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  • Section 3. Lichen Sclerosus

    As a reminder, the horrors of severe lichen sclerosus can include all of the following and more:

    • phimosis of the clitoral hood with decreased sensation and anorgasmia
    • decreased blood flow,
    • fissures (pain),
    • itching to the point of torment
    • bleeding & pain with walking,
    • pain, bleeding, & tearing with defecation,
    • pain with urination,
    • pain and bleeding from wearing jeans (any tight clothing),
    • pain, bleeding, and tearing of tissue with sex (dyspareunia), often causing years of being unable to tolerate any penetration even if aroused,
    • secondary loss of libido when sex becomes associated with pain,
    • permanent destruction of the labia (especially in prepubescent girls),
    • all of the above torments can lead to loneliness from broken and strained love relations,
    • which can lead to broken families,
    • depression,
    • loss of self-esteem,
    • an overall painful day-to-day life.

    In other words, imagine trying to enjoy just about anything while your genitalia is hurting, cracking, itching, and bleeding.

    Here’s a photo of what many women who suffer from LS wake to find between their legs in the morning (often) without hope of relief after years of the usual daily clobetasol.

    They also can look forward to a ten percent chance of squamous cell carcinoma with the resultant needed vulvectomy.

    Lichen sclerosus is thought to be caused by the autoimmune process, hence the usual treatment—a strong topical steroid cream, clobetasol.

    Unfortunately, even with clobetasol, many women continue to suffer both the tormenting symptoms and the 10% risk of squamous cell carcinoma. We need a better way.

    Since the O-Shot® procedure utilizes PRP, to understand how the procedure may help those suffering from lichen sclerosus, consider all of the following:

    1. The effects of PRP on the autoimmune process,
    2. The effects of PRP on scaring,
    3. The effects of PRP on wound healing,
    4. How the O-Shot® procedure may be modified to best treat lichen sclerosus.

    PRP Down-Regulates the Autoimmune Response

    In thinking about the use of PRP for use in lichen sclerosus, consider other autoimmune conditions in which PRP has been shown to down-regulate the disease process.

    Vitiligo treatment usually involves steroids or melanocyte transplantation, both of which can lead to unsatisfactory results. But, studies showed a dramatic improvement with PRP.

    Also, alopecia areata (usually treated with steroids) responded better to PRP than to steroids in more than one study, with more and darker hair follicles when using PRP compared with steroids.

    For rheumatoid arthritis (also an autoimmune process), studies demonstrated that PRP did all the following:

    alleviated arthritis, and reduced humoral and cellular immune responses, leading to beneficial effects on histological parameters as observed using joint tissue histological staining. CIA mice treated with PRP exhibited downregulated expression of IL-6, IL-8, IL-17A, IL-1β, TNF-α, receptor activator for nuclear factor-κB and IFN-γ in inflammatory tissue. In addition, VEGF, PDGF, IGF‑1 and TGF-β expression in peripheral whole blood was increased following treatment with PRP. The serum concentration of anti-collagen antibody was decreased in PRP-treated CIA mice. In conclusion, CIA mice treated with PRP exhibited beneficial effects, including decreased joint inflammation, cartilage destruction and bone damage, and increased repair (Tong2017).

    Even experimental autoimmune encephalitis and Bell’s Palsy (both autoimmune in etiology) have shown benefit from PRP.

    With benefit shown in these and other autoimmune conditions, it is within reason that PRP may be of help in attenuating or arresting the autoimmune activity and the resultant progression of signs and symptoms of lichen sclerosus.

    PRP Remodels Scar Tissue into Healthier Tissue

    With the recurrent cracking, bleeding, and sclerotic changes that plague women with lichen sclerosus (LS), even if the LS is magically turned off, there is still a need to remodel the scarring from the previous activity of the disease.

    PRP has been used to treat acne scars, postpartum striae, cleft-palate-repair scars, and even the scars left from devices used to treat breast cancer patients.

    With the breast cancer patients, there was even seen an increased survival rate in the women who received the PRP; the authors considered it coincidental even though the benefit was statistical (Eichler2022). It’s too early to claim from this one study that PRP can protect against recurrence of breast cancer; but, similar data was seen with fat transfer for reconstruction after breast cancer. Two studies showed those who received fat (usually mixed with PRP to improve survival of the fat) showed a trend toward prolonged survival; in these two studies, the increased survival was measured but not statistically relevant. Still, these and other studies indicate that PRP is, at worst, safe in the face of women at high risk for recurrence of their breast cancer.

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    This discussion regarding the lack of increased risk of neoplasia when using PRP is significant considering that ten percent of women with lichen sclerosus will develop squamous cell carcinoma as part of the progression and ongoing disease activity of the lichen sclerosus. One might postulate that with decreased disease activity that results from the use of PRP in some women, the risk of squamous cell carcinoma might also be decreased.

    Even in women who use clobetasol like a religion, women still face a 10% risk of squamous cell carcinoma, and little is known about the effects of chronic use of clobetasol on the recurrence or occurrence of other problems like HPV (since chronic steroids could affect the local immune system). But, the fear that PRP its self may propagate neoplasia should be addressed and has been; as of yet, thousands of studies have indicated that neoplasia is not a risk when PRP is used. A growing number of studies indicate (but do not conclusively prove) that PRP may decrease the risk of neoplasia; long-term follow-up in those with lichen sclerosus needs to be done before we can claim a decreased rate of progression to squamous cell carcinoma in women who use PRP for treatment.

    PRP Promotes Wound Healing

    Just pretend for a moment that you have a magic wand and that if you wave that wand over the diseased tissue of a woman suffering from lichen sclerosus, then her disease activity will immediately go quiescent. Now consider this: what if your needle becomes like a magic wand for many women when you fill it with PRP? Now, you wave your magic wand, and the autoimmune process of the lichen sclerosus shuts off.

    Does the woman immediately feel immediately well if you instantly turn off the disease activity?

    Not at all, because she would still be left with the ravages of the process; before feeling well, she would need to replace sclerotic tissue with healthy tissue, to heal fissures, and to regrow blood vessels into the damaged tissue.

    So, in effect, she would need to heal the wounds of the lichen sclerosus before she would enjoy a healthy vulva, even if you magically and instantly shut off the lichen sclerosus. Unfortunately, cortisone (used by most women to treat lichen sclerosus) delays wound healing. In comparison, a material (PRP) that both shuts off the overactive autoimmune process (and therefore shuts off the lichen sclerosus) and also promotes (rather than delaying) the healing of the damaged tissue could provide a remarkable synergy of benefits.

    As we have discussed in previous sections of this report, the primary work that led to the widespread use of PRP and to the development of the devices used for the preparation of PRP began in the effort to heal surgical wounds in avascular areas like the cartilage of the knee and the bone in oral surgery. This idea of healing avascular surgical wounds with PRP extended with the publishing of many papers regarding the use of PRP to promote the healing of hard-to-heal wounds in the distal extremities of those suffering from diabetes.

    Before using PRP in the genitals, I developed a method of using PRP in the face, the Vampire Facelift® for cosmetic purposes and many papers were published regarding using PRP in the scalp for reviving hair follicles. With cosmetic procedures and with hair regrowth, we are not healing a wound; instead, we are starting the cascade with PRP that would occur if there were a wound, with the result that healthier and younger-appearing tissue develops.

    With lichen sclerosus, we not only face an active autoimmune process that creates sclerosis and blood vessel destruction, we also face the secondary wounds of fissures and excoriations. So, using PRP to help heal these wounds could be of great benefit.

    PRP Helps Some Women with Lichen Sclerosus (both with and without phimosis)

    When I first met Dr. Andrew Goldstein, he was lecturing to the International Society for Women’s Sexual Health regarding a genetic marker that could predict which women might suffer dyspareunia as a complication of taking birth control pills (yes, this is a known complication). He also revealed to the audience that he was in the process of passing a kidney stone while he was giving the lecture! I found his lecture to be brilliant and his grit to be impressive.

    So, after his talk, I approached him about the possibility of doing research together. Knowing of my work with the O-Shot® procedure, he suggested we do a study regarding the use of PRP for lichen sclerosus. At that time, Dr. Casabona had published an article demonstrating that stem cells would improve lichen sclerosus but no one had published anything regarding PRP for LS.

    I agreed to sponsor the study on the spot, and we exchanged numbers.

    Some months later, we published a study where women suffering from LS were biopsied, treated with PRP, and then surveyed for changes in symptoms and re-biopsied. Two dermatopathologists with much experience with LS were blinded to which was the before and which was the after biopsy. Both the surveys of the women and the biopsies demonstrated a statistical improvement in lichen sclerosus after treatment with PRP. We then extended the numbers of women in the study and published a second paper—also showing a statistical benefit to PRP for LS. These were the first two studies to show the benefit of LS after treatment with PRP using a variation of our O-Shot® procedure.

    Then, after our second study, a woman who suffered with lichen sclerosus and who had been greatly helped by PRP, sponsored a third study. In this study (done without my participation), saline was used as a placebo. In other words , the women in one group were injected with PRP and the women in the second group were injected with saline.

    Ironically, in this third study (sponsored by a woman who’s LS improved after treatment with PRP), where saline was used as a placebo, there was no statistical difference between the placebo group and the PRP group; but, 50% of the women in the placebo group improved!

    In short, both groups got better, and the group that was injected with PRP did better than the saline group; but because there was such a strong response rate in the “placebo” group, there was not a statistical difference between the two and the authors concluded that PRP does not work.

    Put another way: a generous woman suffering from LS who got better with PRP paid for a study of treating LS with PRP—and the authors she hired concluded that there was “no benefit” from PRP, the same treatment that got the woman financier well.

    I think something more important was shown by the study than that PRP does not help LS: the research further demonstrates the idea shown by others that saline, when used for hydrodissection, is not a placebo. Saline can even be used to treat scars and even to decrease pain.

    Especially when saline is injected in such a way that it causes hydrodissection, there can be measurable changes in the tissue resulting from the resultant micro-trauma followed by post-op healing.

    So, in this third study, Dr. Goldstein and his collaborators concluded (in contradiction to our previous two studies) that PRP offers no benefit. But, this was a study with biopsies, not simply a survey; I cannot find another study of LS where 50% of the placebo group improved on biopsy. I think that Dr. Goldstein showed something more important than what he reported; I think his study showed that hydrodissection alone precipitates changes (as has been shown with other conditions) that improve LS and that PRP can be used for the hydrodissection for benefits measurably better than saline alone.

    In other words, I think what Dr. Goldstein showed was that, with our O-Shot®, there is not simply a biological effect from the growth factors; there is also a mechanical effect—essentially a surgical effect—from the mechanical hydrodissection of injecting the PRP.

    I have tremendous respect for Dr. Goldstein and his knowledge of lichen sclerosus, but I think my interpretation of his research can be different than his and still maintain great respect for his work. 

    Put simply; the O-Shot® is a mechanical procedure combined with a biochemical cascade.

    Other studies have since been published showing that PRP can improve lichen sclerosus.

    The O-Shot® for Those with Phimosis

    A woman of fifty-three years old came to my office because she had been unable to tolerate her husband’s penis for 7 years because of her lichen sclerosus. She was using daily clobetasol and being followed by her dermatologist with regular visits for the entire 7 years.

    In addition to being unable to tolerate more than about two inches of one of my fingers inserted into her vagina because her clitoris was completely covered by her phimosed clitoral hood, she reported that she enjoyed very little pleasure from her attempts to masturbate.

    Her husband, who came with her to my office, as is often the case, seemed loving and content but suffered empathetically for his wife because she enjoyed very little sexual pleasure of any kind. There is this idea in some circles that women only want to heal their vagina so they can please their husbands and that we should just leave such women alone, that if it were not for demanding men that they would be just fine; but, if you see only a few women with LS, you realize how very wrong is that idea; husband or no husband, women with LS can lose the ability to enjoy sexual pleasure and often feel broken and alone.

    In the following photograph, the first image on the far left shows her vagina on the day she came to my office.

    I injected her labia, clitoral hood, the clitoris (through the hood), the entire area, and the anterior vagina wall.

    I am not a surgeon, so I sent her to an excellent board-certified gynecologist near my office, Dr. Kathleen Posey, who then dissected out the clitoris—freeing it from the scaring phimosis that had it trapped.

    Research has shown that with LS even if the hood is completely phimosed such that the clitoris is unreachable, the clitoris is not directly affected by LS and, when freed, will function normally.

    Dr. Posey took the second photo (the one in the middle) on the day she freed the clitoris.

    Normally, with such a surgery in a woman suffering from LS, there would likely be a quick recurrence of sclerosis with re-entrapment of the clitoris beneath the LS-diseased clitoral hood.

    Instead of the hood re-phimosing, six weeks later, Dr. Posey took the photograph on the far right demonstrating that the hood and labia had grown healthier in appearance, and the woman reported she was having comfortable sex with her husband for the first time in over seven years—off of her clobetasol!

    She continues to get a modified O-Shot® from Dr. Posey every year or so and to enjoy comfortable sex.

    Dr. Posey went on to treat other women in this way and published her findings (Posey2015).

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    Alexandra Runnels, MD, sent photos of a patient who had ten years of Clobetasol and was working as a soldier—imagine marching, and that’s what you have to remind yourself with itching, burning, and bleeding—every time you take a step with your pack.

    And then, after stopping the Clobetasol—she achieved the results on the right by using a combination of PRP with micro-needling to the more sclerotic areas and the usual 2-injection O-Shot®, combined with injecting PRP into the area and using daily UVB light, combined with Altar® cream to achieve the much healthier tissue (see below).

    The phimosis surgery was done about 8 weeks after the first PRP treatment. Her marriage and her self-image and her life changed for the better.

    O-Shot® Variations for the Treatment of Lichen Sclerosus

    • Techniques: For phimosis, after you dissect the clitoris to freedom, then injecting with PRP and micro-needling the more sclerotic areas seems to work well in about 80% of women with LS.
    • This summary neither qualifies nor fully instructs in the O-Shot® procedure for lichen sclerosus. Application for training can be found here<-- or by callling the Cellular Medicine Association at 1-888-920-5311
    • Not all women respond; if no improvement, they go back on clobetasol.
    • Stop clobetasol 3-5 days before the treatment and see the woman back in 3 to 6 weeks.
    • Reinject on sec0nd visit any active areas.
    • Expect to need to reinject every six to eighteen months.
    • Works in synergy with UV light
    • Have a low threshold for rebiopsy.
    • Bring back at least once every 6 months to revaluate.
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    Summary

    • PRP, when injected in some women suffering from lichen sclerosus, provides a dramatic down-regulation of their disease.
    • There is, of yet, no sure-fire “cure” for lichen sclerosus. Not everyone responds to PRP and those who do usually require repeated treatments every nine to eighteen months. Also, not everyone finds complete relief from clobetasol. It does appear that some who do not find relief from clobetasol do find relief from PRP and vice versa.
    • Those who do not respond to PRP should be put back on clobetasol. Those who find complete relief from clobetasol may not need PRP.
    • Biopsies should always be done regularly as we do not yet have a sure way of preventing the progression of lichen sclerosus to squamous cell carcinoma—clobetosol does not completely prevent the progression and it’s unlikely that PRP completely prevents the progression.
    • Studies of other diseases processes (like breast cancer), and over 15,000 published papers on PubMed regarding PRP without complication from neoplasia, indicate that PRP does not increase the risk of neoplasia.
    • If PRP is carcinogenic, then every surgery should be carcinogenic, considering the same growth factors are released from platelets in the healing of a surgical wound as are released from PRP.
    • It seems logical that in the women who respond to the O-Shot® procedure, there would be less risk of squamous cell carcinoma since the disease seems to go quiescent, but we do not yet know if this is the case.

    References

    Research Regarding the Use of PRP for Autoimmune Disease

    1. Vazquez OA, Safeek RH, Komberg J, Becker H. Alopecia Areata Treated with Advanced Platelet-rich Fibrin Using Micronization. Plast Reconstr Surg Glob Open. 2022;10(1):e4032. doi:10.1097/GOX.0000000000004032
    2. Anitua E, Pino A, Aspe L, et al. Anti-inflammatory effect of different PRGF formulations on cutaneous surface. Journal of Tissue Viability. 2021;30(2):183-189. doi:10.1016/j.jtv.2021.02.011
    3. Huber SC, de Lima Montalvão SA, Sachetto Z, Santos Duarte Lana JF, Annichino-Bizzacchi JM. Characterization of autologous platelet rich plasma (PRP) and its biological effects in patients with Behçet’s Disease. Regen Ther. 2021;18:339-346. doi:10.1016/j.reth.2021.08.010
    4. Rekik M, Mseddi M, Nadine K, Sellami K, Turki H. Efficacy of autologous platelet-rich plasma in the treatment of vitiligo : A 10- patient prospective study. Journal of Cosmetic Dermatology. n/a(n/a). doi:10.1111/jocd.15050
    5. Tong S, Zhang C, Liu J. Platelet-rich plasma exhibits beneficial effects for rheumatoid arthritis mice by suppressing inflammatory factors. Mol Med Rep. 2017;16(4):4082-4088. doi:10.3892/mmr.2017.7091
    6. Seffer I, Nemeth Z. Recovery from Bell Palsy after Transplantation of Peripheral Blood Mononuclear Cells and Platelet-Rich Plasma: Plastic and Reconstructive Surgery – Global Open. 2017;5(6):e1376. doi:10.1097/GOX.0000000000001376
    7. Pototschnig H, Madl MT. Successful Treatment of Alopecia Areata Barbae with Platelet-rich Plasma. Cureus. 2020;12(4):e7495. doi:10.7759/cureus.7495
    8. Trink A, Sorbellini E, Bezzola P, et al. A randomized, double-blind, placebo- and active-controlled, half-head study to evaluate the effects of platelet-rich plasma on alopecia areata. British Journal of Dermatology. 2013;169(3):690-694. doi:10.1111/bjd.12397
    9. Borhani-Haghighi M, Mohamadi Y. The therapeutic effect of platelet-rich plasma on the experimental autoimmune encephalomyelitis mice. J Neuroimmunol. 2019;333:476958. doi:10.1016/j.jneuroim.2019.04.018
    10. Behnia-Willison F, Pour NR, Mohamadi B, et al. Use of Platelet-rich Plasma for Vulvovaginal Autoimmune Conditions Like Lichen Sclerosus. Plast Reconstr Surg Glob Open. 2016;4(11):e1124. doi:10.1097/GOX.0000000000001124
    11. Pensato R, La Padula S. The Effect of Lipofilling and Platelet-Rich Plasma on Patients with Moderate–Severe Vulvar Lichen Sclerosus Who were Non-responders to Topical Clobetasol Propionate: A Randomized Pilot Study. Aesth Plast Surg. Published online May 31, 2022. doi:10.1007/s00266-022-02947-y

    Research Showing PRP Remodels Scar Tissue

    1. Alves R, Grimalt R. A Review of Platelet-Rich Plasma: History, Biology, Mechanism of Action, and Classification. Skin Appendage Disord. 2018;4(1):18-24. doi:10.1159/000477353
    2. Gawdat H, El-Hadidy YA, Allam RSHM, Abdelkader HA. Autologous platelet-rich plasma “fluid” versus “gel” form in combination with fractional CO2 laser in the treatment of atrophic acne scars: a split-face randomized clinical trial. Journal of Dermatological Treatment. 2022;0(ja):1-31. doi:10.1080/09546634.2022.2067816
    3. Charles-de-Sá L, Gontijo-de-Amorim NF, Takiya CM, et al. Effect of Use of Platelet-Rich Plasma (PRP) in Skin with Intrinsic Aging Process. Aesthet Surg J. 2018;38(3):321-328. doi:10.1093/asj/sjx137
    4. Eichler C, Üner J, Thangarajah F, et al. Platelet-rich plasma (PRP) in oncological patients: long-term oncological outcome analysis of the treatment of subcutaneous venous access device scars in 89 breast cancer patients. Arch Gynecol Obstet. Published online April 4, 2022. doi:10.1007/s00404-022-06416-4
    5. Number 5 SV 24. Platelet-Rich Plasma (PRP): Current Applications in Dermatology. Accessed August 26, 2021. https://www.skintherapyletter.com/dermatology/platelet-rich-plasma-prp/
    6. Sánchez M, Anitua E, Delgado D, et al. Platelet-rich plasma, a source of autologous growth factors and biomimetic scaffold for peripheral nerve regeneration. Expert Opinion on Biological Therapy. 2017;17(2):197-212. doi:10.1080/14712598.2017.1259409

    Research Showing the PRP Promotes Wound Healing

    1. Autologous platelet-rich plasma vs conventional dressing in the management of chronic diabetic foot ulcers – PubMed. Accessed March 7, 2022. https://pubmed.ncbi.nlm.nih.gov/35108667/
    2. Pourkarim R, Farahpour MR, Rezaei SA. Comparison effects of platelet-rich plasma on healing of infected and non-infected excision wounds by the modulation of the expression of inflammatory mediators: experimental research. Eur J Trauma Emerg Surg. Published online February 12, 2022. doi:10.1007/s00068-022-01907-0
    3. García-Sánchez JM, Mirabet Lis V, Ruiz-Valls A, Pérez-Plaza A, Sepúlveda Sanchis P, Pérez-del-Caz MD. Platelet rich plasma and plasma rich in growth factors for split-thickness skin graft donor site treatment in the burn patient setting: A randomized clinical trial. Burns. Published online October 22, 2021. doi:10.1016/j.burns.2021.10.001
    4. Chicharro-Alcántara D, Rubio-Zaragoza M, Damiá-Giménez E, et al. Platelet Rich Plasma: New Insights for Cutaneous Wound Healing Management. J Funct Biomater. 2018;9(1):10. doi:10.3390/jfb9010010
    5. Spanò R, Muraglia A, Todeschi MR, et al. Platelet-rich plasma-based bioactive membrane as a new advanced wound care tool. Journal of Tissue Engineering and Regenerative Medicine. 2018;12(1):e82-e96. doi:10.1002/term.2357
    6. Saputro ID, Rizaliyana S, Noverta DA. The effect of allogenic freeze-dried platelet-rich plasma in increasing the number of fibroblasts and neovascularization in wound healing. Ann Med Surg (Lond). 2022;73:103217. doi:10.1016/j.amsu.2021.103217
    7. Kelm RC, Ibrahim O. Utility of platelet-rich plasma in aesthetics. Clinics in Dermatology. 2022;40(1):19-28. doi:10.1016/j.clindermatol.2021.08.007

    Research Regarding Fat Transfer to the Breast and No Increased Risk of Breast Cancer and that PRP is Safe with a History of Breast Cancer

    1. Kaoutzanis, Christodoulos, Minqiang Xin, Tiffany N.S. Ballard, Kathleen B. Welch, Adeyiza O. Momoh, Jeffrey H. Kozlow, David L. Brown, Paul S. Cederna, and Edwin G. Wilkins. “Autologous Fat Grafting After Breast Reconstruction in Postmastectomy Patients: Complications, Biopsy Rates, and Locoregional Cancer Recurrence Rates.” Annals of Plastic Surgery 76, no. 3 (March 2016): 270–75. https://doi.org/10.1097/SAP.0000000000000561.
    2. Kronowitz, Steven J., Cosman Camilo Mandujano, Jun Liu, Henry M. Kuerer, Benjamin Smith, Patrick Garvey, Reshma Jagsi, Limin Hsu, Summer Hanson, and Vicente Valero. “Lipofilling of the Breast Does Not Increase the Risk of Recurrence of Breast Cancer: A Matched Controlled Study.” Plastic and Reconstructive Surgery 137, no. 2 (February 2016): 385–93. https://doi.org/10.1097/01.prs.0000475741.32563.50.
    3. Eichler C, Baucks C, Üner J, et al. Platelet-Rich Plasma (PRP) in Breast Cancer Patients: An Application Analysis of 163 Sentinel Lymph Node Biopsies. Guan X yuan, ed. BioMed Research International. 2020;2020:1-7. doi:10.1155/2020/3432987d

    Research Showing Improvement of Lichen Sclerosus with UVB

    Garrido-Colmenero C, Martínez-Peinado CM, Galán-Gutiérrez M, Barranco-Millán V, Ruiz-Villaverde R. Successful response of vulvar lichen sclerosus with NB-UVB. Dermatologic Therapy. 2021;34(2):e14801. doi:10.1111/dth.14801

    Research Regarding Steroids Reactivating Papilloma Virus

    von Krogh G, Dahlman-Ghozlan K, Syrjänen S. Potential human papillomavirus reactivation following topical corticosteroid therapy of genital lichen sclerosus and erosive lichen planus. Journal of the European Academy of Dermatology and Venereology : JEADV. 2002;16(2):130-133. Accessed August 24, 2015. http://www.ncbi.nlm.nih.gov/pubmed/12046814

    Research Showing that PRP Helps Women Suffering from Lichen Sclerosus

    1. Goldstein AT, Mitchell L, Govind V, Heller D. A Randomized Double-Blind Placebo Controlled Trial of Autologous Platelet Rich Plasma Intradermal Injections for the Treatment of Vulvar Lichen Sclerosus. Journal of the American Academy of Dermatology. Published online January 2019. doi:10.1016/j.jaad.2018.12.060
    2. Msc MK, Tolson H, Runels C, Gloth M, Pfau R, Goldstein AT. Autologous Platelet Rich Plasma (PRP) Intradermal Injections for the Treatment of Vulvar Lichen Sclerosus. Journal of Lower Genital Tract Disease. 2015;19(3):S1-S25. http://journals.lww.com/jlgtd/Fulltext/2015/07001/ISSVD2015Abstracts.2.aspx
    3. Casabona F, Gambelli I, Casabona F, Santi P, Santori G, Baldelli I. Autologous platelet-rich plasma (PRP) in chronic penile lichen sclerosus: the impact on tissue repair and patient quality of life. Int Urol Nephrol. 2017;49(4):573-580. doi:10.1007/s11255-017-1523-0
    4. Mitchell L, Goldstein AT, Heller D, et al. Fractionated Carbon Dioxide Laser for the Treatment of Vulvar Lichen Sclerosus: A Randomized Controlled Trial. Obstetrics & Gynecology. 2021;137(6):979-987. doi:10.1097/AOG.0000000000004409
    5. Goldstein AT, King M, Runels C, Gloth M, Pfau R. Intradermal injection of autologous platelet-rich plasma for the treatment of vulvar lichen sclerosus. Journal of the American Academy of Dermatology. 2017;76(1):158-160. doi:10.1016/j.jaad.2016.07.037
    6. Posey K, Runels C. In-Office Surgery and Use of Platelet Rich Plasma for Treatment of Vulvar Lichen Sclerosus to Alleviate Painful Sexual Intercourse. Journal of Lower Genital Tract Disease. 2015;19(3):S1-S25. doi:10.1097/lgt.0000000000000121
    7. ISSVD 2015 Abstracts. Journal of Lower Genital Tract Disease. 2015;19(3):S1-S25. doi:10.1097/lgt.0000000000000121
    8. Lee A, Bradford J, Fischer G. Long-term management of adult vulvar lichen sclerosus: a prospective cohort study of 507 women. JAMA Dermatol. 2015;151:1061-1067.
    9. Casabona F, Priano V, Vallerino V, Cogliandro A, Lavagnino G. New surgical approach to lichen sclerosus of the vulva: the role of adipose-derived mesenchymal cells and platelet-rich plasma in tissue regeneration. Plastic and reconstructive surgery. 2010;126(4):210e-211e.
    10. Franic D, Iternička Z, Franić-Ivanišević M. Platelet-rich plasma (PRP) for the treatment of vulvar lichen sclerosus in a premenopausal woman: A case report. Case reports in women’s health. 2018;18:e00062. doi:10.1016/j.crwh.2018.e00062
    11. Smith JG. The journal of the American Academy of Dermatology. International journal of dermatology. 2005;18(6):466-467. http://www.ncbi.nlm.nih.gov/pubmed/19539853
    12. Vittrup G, Mørup L, Heilesen T, Jensen D, Westmark S, Melgaard D. The Quality of Life and Sexuality in Women with Lichen Sclerosus – A Cross Sectional Study. Clinical and Experimental Dermatology. n/a(n/a). doi:10.1111/ced.14893
    13. Tedesco M, Pranteda G, Chichierchia G, al. et. The use of PRP (platelet-rich plasma) in patients affected by genital lichen sclerosus: clinical analysis and results. J Eur Acad Dermatol Venereol. 2019;33:e58-e59.
    14. Marnach ML, Torgerson RR. Therapeutic Interventions for Challenging Cases of Vulvar Lichen Sclerosus and Lichen Planus. Obstetrics & Gynecology. 2021;138(3):374-378. doi:10.1097/AOG.0000000000004498
    15. Behnia-Willison F, Pour NR, Mohamadi B, et al. Use of Platelet-rich Plasma for Vulvovaginal Autoimmune Conditions Like Lichen Sclerosus: Plastic and Reconstructive Surgery – Global Open. 2016;4(11):e1124. doi:10.1097/GOX.0000000000001124
    16. Corazza M, Schettini N, Zedde P, Borghi A. Vulvar Lichen Sclerosus from Pathophysiology to Therapeutic Approaches: Evidence and Prospects. Biomedicines. 2021;9(8):950. doi:10.3390/biomedicines9080950
    17. Krapf JM, Mitchell L, Holton MA, Goldstein AT. Vulvar Lichen Sclerosus: Current Perspectives. IJWH. 2020;Volume 12:11-20. doi:10.2147/IJWH.S191200

    Research Indicating the Saline Is Not Be A Placebo When Used for Hydrodissection

    1. Clinical benefit of intra-articular saline as a comparator in clinical trials of knee osteoarthritis treatments A systematic review and meta-analysis of randomized trials | Elsevier Enhanced Reader. doi:10.1016/j.semarthrit.2016.04.003
    2. Sharma R, Gupta M, Rani R. Delineating injectable triamcinolone-induced cutaneous atrophy and therapeutic options in 24 patients—A retrospective study. Indian Dermatol Online J. 2022;13(2):199. doi:10.4103/idoj.idoj48321
    3. Asghar A, Tahir Z, Ghias A, Iftikhar U, Ahmad TJ. Efficacy and Safety of Intralesional Normal Saline in Atrophic Acne Scars. Annals of King Edward Medical University. 2019;25(2). doi:10.21649/akemu.v25i2.2867
    4. Bagherani N, R Smoller B. Introduction of a novel therapeutic option for atrophic acne scars: saline injection therapy. Glob Dermatol. 2016;2(6). doi:10.15761/GOD.1000159
    5. Searle T, Al-Niaimi F, Ali FR. Saline in dermatologic surgery. Journal of Cosmetic Dermatology. 2021;20(4):1346-1347. doi:10.1111/jocd.13996
    6. El-Amawy HS, Sarsik SM. Saline in Dermatology: A literature review. Journal of Cosmetic Dermatology. 2021;20(7):2040-2051. doi:10.1111/jocd.13813
    7. Saltzman BM, Leroux T, Meyer MA, et al. The Therapeutic Effect of Intra-articular Normal Saline Injections for Knee Osteoarthritis: A Meta-analysis of Evidence Level 1 Studies. Am J Sports Med. 2017;45(11):2647-2653. doi:10.1177/0363546516680607

     

  • PRP for Improved Sexual Function. International Society for Cosmetogynecology

    International Society for Cosmetogynecology<–

    Cellular Medicine Association<–

    Transcript

    Dr. Marco Pelosi III: Our next speaker is probably best described as the Michael Jordan of platelet rich plasma, Dr. Charles Runels from Alabama, that pioneered the O-Shot® [Orgasm Shot®], the Vampire [Face]lift®, the P-Shot® [Priapus Shot®], and he’s taken all the abuse and he’s given the world some very, very useful procedures for everyone. He’s going to talk about the studies he did and the studies done in platelet rich plasma in regards to sexual function. Dr. Runels, it’s a pleasure to have you here.

    Dr. Runels: Thank you for having me.

    I’m going to go through a whirlwind look at research that’s been done where people have used PRP to help with sex. Much of the research has been done by the people in our group, and I’ve described many of them in this room who have done this research. It’s a for-profit organization, but we pay for research, we pay for education, we pay for marketing for our providers. Just to echo what you just heard, sex is much more than about just having fun. Rainer Maria Rilke said it’s just so correlated to the creative experience that it’s affecting how we do our work, how you do your presentation, and how – of course – relationships and families.

    I want to echo that sentiment, and remind us that back in 1980, if you look in ‘Urology’ – this was ‘Urology’ 1980 – the most common cause for erectile dysfunction was thought to be 85% psychogenic. Here’s a quote from ‘Urology’ where urologists were encouraged to become counselors, because most of erectile dysfunction was thought to be psychogenic. Of course, I’m echoing the penis stuff because if you take a penis and shrink it and unzip it, that becomes a clitoris. I’m thinking most of the research will eventually apply to that. Certainly, our attitude is applying because we’re back in the … We’re not, I’m preaching to the choir, but many of our colleagues are back in the 1980’s and saying the main thing we have for sexuality for women is counseling.

    My thinking that perhaps, as you guys do, some of the pathology that applies to the penis may apply to the clitoris, and maybe some of these women are suffering from actual genital histopathology, not just psychogenic problems. We have this one FDA approved drug now for female sexual dysfunction that’s a psych drug, flibanserin. It’s a useful drug, but obviously, we need much more and maybe we should think in terms of systems, like we do for the rest of the body.

    Into play is platelet rich plasma. Obviously, this is not a new idea. This is from, this month, over 9,000 papers indexed in PubMed about platelet rich plasma. Our orthopedic colleagues, our dentist, our facial plastic surgeons have worked with this, and all we have to do is take their ideas and then hopefully people in this room will extend what I’m about to show you and just take those ideas and adapt them to the genital space. Here’s some of the growth factors we know about. There are many more. They have these effects. These are good things for the genitalia. Down-regulating autoimmune response, proliferation of fibroblasts, new angiogenesis, the adipocytes enlarge and multiply – think labia majora, collagen production, neurogenesis and maybe some glandular function.

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    There’s never, in all those 9,000 papers, I still cannot find one serious side effect. No granulomas, no serious infection. PRP is what your body makes to heal when you do your surgeries and help prevent infection. Obviously, there are always certain things that can happen, bruising and such, but if you have a serious life-threatening complication from PRP, you will have the first recorded in all of that 9,000 plus papers. That’s a nice thing.

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    We have commercially available methods for preparing it, within 5 or 10 minutes of the bedside, and the devices are FDA approved. So you guys don’t get confused, obviously the FDA does not approve your procedures. That’s a doctor business. They don’t approve blood that belongs to you, just like your spit and your saliva and your skin. They tried, at one time, to control eggs and the gynecologists said, “Hell no.” So they don’t control eggs and they don’t control blood, but you should use an FDA approved device if you do this [approved for preparation of PRP to go back into the body].

    Here’s some of the ideas about down-regulating autoimmune response. We have split-scalp studies showing that PRP helps alopecia areata better than triamcinolone. More hair growth that comes in thicker. Here’s rat studies looking at rheumatoid arthritis. What do we have in the genital space? We have lichens sclerosus. We did some before and after pictures where you use stem cells mixed with PRP, and before and after pictures show improvement. Of course, that’s two variables because you have stem cells and you have the PRP.

    We took the same idea and just used PRP. Andrew Goldstein worked with me on this, and we had two blinded dermatopathologists. The protocol was biopsy, PRP, wait six weeks later, another PRP injection, and then six weeks after that, another biopsy. Two blinded dermatopathologists out of George Washington University did not know the before or the after. We showed statistical improvement in both the histology and symptomatology. Here’s our histology. You can see obviously, that’s the same magnification and we’re showing decreased hyperkeratosis. That’s obviously healthier tissue. A layperson could tell that’s better. Of course if you look at the gross pictures, lady on the left as you guys know, she has pain wearing her blue jeans. The lady on the right is back to making love to her husband. They’ve invited me into their close Facebook groups and I saw a post a few months ago. Quote says, “I was sitting next to my husband, whom I love, last night. I was afraid to hold his hand because I was afraid he would become aroused and I’m bleeding and hurting today.” That’s what you guys are helping.

    We published that in ‘Lower Genital Tract Disease’. We extended it because it worked. We published this past January in the journal of the American Academy of Dermatology. You have some science to go do this now.

    One of our providers, Kathleen Posey, who’s a gynecologist out of New Orleans, took this idea and then she said, “Let’s do some dissection in the office”, and she presented this in Argentina, published it in the same journal ‘Lower Genital Tract Disease’. Here’s one of her patients, where you can introduce [inaudible 00:06:44]. It had been 12 years since she had had sexual intercourse, penis and vagina intercourse, with her loving husband … 12 years. She was being followed by a dermatologist on high dose clobetasol. Kathleen dissected it out in the office and then injected PRP … 8 weeks later, she’s having comfortable sex with her husband. She’s now 3 years out. She’s had to be treated with PRP, not repeat surgery … PRP now, 2 other times a year apart to maintain that result. She now has a series of 60 or so patients that she’s now going to publish with similar results, where she’s dissecting out – as you guys know how to do – treating the [inaudible 00:07:27], but then following that with PRP injections to help the healing and decease the autoimmune response.

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    That same doctor, Casabona, repeated his study with lichen sclerosus in men [BXO], and showed with just PRP alone … This study of 45 men with repeat treatments … It is cumulative, 2 to 10 treatments, the same thing. All of them stopped their steroids. None of them started back. Only one went on to have circumcision.

    Peyronie’s disease, another autoimmune disease … This came out this month out of Wake Forest, where they took men and they followed their results with Peyronie’s disease. Not only did their Peyronie’s improve statistically, but they also improved their erectile dysfunction by 5 on that scale of 5 to 25 that the urologists use. For some reason, thankfully, they threw in one woman just for good measure, and showed that it helped her incontinence. They just tucked that in as an aftermath.

    Ronald Virag, as you guys know as the legendary vascular surgeon who was first to present the idea of intracavernosal injections for erectile dysfunction, out of Paris. His big thing now is PRP for Peyronie’s. He just published a study where he showed that this is comparing PRP with Xiapex, which is a $50,000 series of injections, FDA approved version of collagenase. He showed that PRP works better with few side effects. There’s a risk of about 1 in 30, that actually go from a bent pencil to a fractured pencil and a limp noodle. You don’t see that with PRP. You see the side effect is the erectile function improves. He showed the same thing, actually, in his studies that erectile dysfunction improves by an average of about 7 on that 5 to 25 point scale.

    Let’s think about the [inaudible 00:09:29] literature. Look at this, there’s so much of this out there. This is looking at post-operative adhesions, lots of studies looking at scarring with microneedling and PRP. This is a split-face study comparing PRP with microneedling verus PRP … Excuse me, microneedling with saline or Vitamin C serum and split-faced studies in PRP wins. Dr. Sclafani did some studies in the cosmetic space looking at increased collagen production and fibroblast activity, and never a neoplasia documented. People worry about that. This is not indiscriminate blindness blind growth. You don’t worry about carcinogenesis when you do surgery and it’s the same PRP that’s causing healing. There’s actually some helpful immune processes that go on, that you could argue actually might help prevent cancer. I’m not going to make that argument but it might need to be made one day.

    If you look further, here’s a wound healing study looking at reepithelialized exposed bone and tendon of the foot and ankle. When I took that and applied, this is a hypertrophic scar that was a year old from cortisone, and then using PRP and Juvederm or HA filler, this is a few days later, a month later, and that’s a year later. Now, take that and think, “How could I use that in the genitourinary space?” Doing that anecdotally, we have many of the members of our group are seeing help with episiotomy scars or dyspareunia, pelvic foreplay instead of injecting that pelvic floor tenderness with triamcinolone. Physiatrist for the past ten years has been using PRP, your sports medicine doctors. Now, when you palpate it, consider injecting with PRP instead. Dyspareunia from mesh and that unknown dyspareunia, we’re seeing this is where we need you guys to help extend the research. The science is there that it should help and it seems to be helping. Not 100%, but about 80% in people with dyspareunia.

    Here is a look at a gentleman who did … He took the mesh out and then he patched the hole with a gel form of PRP and showed benefit. We’re finding anecdotally – no one’s done this study yet, here’s another one for you to pick up … I’m giving you low hanging fruit. We’re seeing anecdotally that if you inject in the distribution of the pudendal nerve, which seems to be inflamed in some women with mesh pain, that their pain will frequently go from 9 out of 10 down to 1 or 2 out of 10, without even taking the mesh out. Just another place where we need some research done.

    Here, we have rat studies looking at inflammation. Let’s think about this one. Here’s a rat study where they modeled cystitis and we are seeing in chronic interstitial cystitis without even infiltrating the bladder, just infiltrating in the periurethral space, some of our women are getting better. I’ve had two separate urologists call me and say, “Charles, I can’t believe it. I was doing this and expecting not this to happen. I have these patients now who have had chronic interstitial cystitis pain for years, and it’s gone.” Not 1005 but finding out who’s going to respond and who’s not and why, there’s a lot of variables that need to be thought about that you guys will hopefully do the research.

    Here’s a study that came out in the ‘Journal of Sexual Medicine’, where a guy took … the [inaudible 00:12:51] men who have an erection of 3 inches or less and then he treated them with PRP, combined with a pump, and showed that if you repeated it every time you did it, it grew by about 7 millimeters. I’ve always thought if I could give you a guarantee half an inch to an inch with anything, I’d get my picture on a postage stamp. I don’t have that yet, but I can tell you that we’re seeing about 60% of the time we do this procedure, men will see some sort of growth.

    If you look at the neovascular space, there was a study out of Southern California that was published in the ‘Journal of Sexual Medicine’ where they transferred adipocyte stem cells to the penis of diabetic rats. They showed new endothelial cell growth and increased nitric oxide activity in the dorsal nerve. Would that be helpful in the clitoris? Probably, but the interesting thing is the adipocyte-derived stem cells were attacked and they died. The postulate was the improvement was from the growth factors.

    I have seen what [inaudible 00:13:52] have seen in that when you inject this in the penis, erectile function goes up on the average of about 5 to 7 per injection. Think about nerve repair. We have rat studies modeling prostrate surgery, showing that the nerves improved with PRP and so we have, again, another clear place where we need studies if you add this now to the usual protocol for rehabilitating the penis post-prostate surgery … would you see benefit? We have seen that in some of our patients who are a year or two out who failed the rehabilitation part of that. Would that help your patients who have, say, numbness and decreased function from riding their bikes too much, or trauma? I don’t know, but it’s worth thinking about and publishing research about.

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    In thinking about where to put this, where we do our O-Shot, when we do PRP to the anterior vaginal wall, we’re putting it as distal from the bladder as possible. We found that it works better. We’re essentially making a liquid sling. Think infiltrating and getting ready to put in the mesh. That’s what we’re doing. Very simple, only we’re using a material that has never caused a granuloma ever. Doing that, frequently our patients will have their incontinence go away that day from the actual liquid and as it’s replaced with new tissue, it never recurs. Usually, you’ll have to repeat the procedure at a year or two out depending on the etiology. Sometimes it lasts longer.

    The interesting idea is what might be happening with those [inaudible 00:15:21]. They become more active, and does that help with sexual function? The other place we put it is in the actual corpus cavernosum of the clitoris. We use [inaudible 00:15:29] ultrasound visualization and see it flow down into the body of the clitoris by the pubic ramus and the wave form goes to what you see in a flaccid penis to what you see in an erect penis.

    That’s my time, almost done. Just 30 more seconds. Here’s a pilot study we did where we showed that in women with female sexual distress, that it dropped by an average of 10 and female sexual function went up by 5 when you do what I just showed you. Here’s a study that Dr. Neto, who may be here, published where he looked at incontinence and sexual function down in Brazil and showed that 94% of the people loved it. The question here is how would you combine it with your energy source? It works great in the face if you do laser and follow it with PRP … better results, faster healing. Is it going to … We need people to help us work out the algorithms. Not everybody has laxity, but when you have something, when do you use which treatment and when do you combine it with PRP? We need those answers, because I don’t have them yet. This is possible helps.

    I am done. Thank you very much for having me. I put all these references at that website, if you want to go download them. Thank you. You guys have a wonderful conference.

    Dr. Marco Pelosi III: Thank you Charles. Beautiful

    More about the Cellular Medicine Association

    O-Shot® Research<–
    P-Shot® Research<–

    Upcoming Workshops With Live Models<–

  • O-Shot® Research. New Study. Double-Blind Placebo Controlled

    Here’s the link to copy and paste into a facebook page, tweet, & send a link to your patients (with the following note…”New research underway to help women with sex. Please forward so that we may find participants”)…

    Click here and then click the facebook, twitter, Google plus links
    to let your patients know about this research (click)<—

    Here’s where to find the research already published…
    click<–

    Here’s our list of certified teachers (soon to be updated with new people)…
    click

    Here’s the new text (Chapter 15 O-Shot® goes well with Chapters 16 & 17 which discuss the use of the O-Shot® in combination with laser and with radiofrequency…

    Thank you very much!
    More good stuff coming soon!

    Charles

    Charles Runels, MD
    888-920-5311
    Calendly.com/CellMed

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