Vulvar Lichen Sclerosus is an inflammatory condition of the vulva, which manifests in itching and burning, with either thickened or thinned skin. Traditionally treated with ultra high-potency steroid creams, these topical prescriptions are not intended for long-term use due to health risks. NEOGYN Vulvar Soothing Cream, now available, can be used as adjunctive care to steroid treatments and part of a successful, longstanding regimen to minimize recurrence and maintain vulvar comfort. NEOGYN Vulvar Soothing Cream is a non-medicated soothing cream ideal for use in combination with other Lichen Sclerosus therapies. A clinical study recently demonstrated a significant improvement in itching, burning and pain reduction after using NEOGYN Vulvar Soothing Cream twice daily for three months. Conducted by Dr. Andrew Goldstein, a leading authority on Lichen Sclerosus and vulvar diseases, the 30 subject, placebo controlled study suggests that adjunctive care such as NEOGYN provides a new option both with steroids and in-between steroid treatments. NeoGyn Vulvar Soothing Cream is a cosmetic product, not a medication. Dr. Goldstein is the author of numerous medical textbooks on Vulvodnia, as well as When Sex Hurts, a woman’s guide to banishing sexual pain. Dr. Goldstein is also the Director of the Center for Vulvovaginal disorders in Washington D.C. and New York City.

1. Safety and Efficacy of Human Fibroblast Lysate Cream for Vulvar Lichen Sclerosus. Andrew Goldstein, Lara Burrows, Richard Pfau, Matthew Bremmer, LaurileeRoybal, CorrieGoldfinger, & Frank Dreher

2. Disclosures: Andrew Goldstein is a consultant and has received research funding for this study from Neogyn, Inc. (Troy, Michigan, USA)

5. Circulating autoimmune antibodies > 50%.2

6. 30% have autoimmune disease: autoimmune thyroiditis, pernicious anemia, vitiligo, alopecia areata.2

7. Circulating autoantibodies to endothelial cell Adhesion molecule (ECAM 1) in 67% and antibodies to BP 180 and BP 230 have been detected in 30% of affected patients.3,41 Lukowsky A, J Invest Dermatol 2000;115:254e9. 2. Ueda K, J Skin Cancer. 2011; 2011: 951250 3 Oyama N, Chan I, Neill SM, et al. Lancet 2003;362:118e23. 4. Howard A, Dean D, Cooper S, et al. Australas J Dermatol 2004;45(1):12e5.

9. Human Fibroblast Lysate Cream Cutaneous Lysate Cellular lysate of cultured human fetal fibroblasts (also called Processed Skin Cell Proteins, or PSP®) Origin of Cells Fully tested Cell Bank Lysate Composition Mixture of >100 cytokines - growth factors (EGF, FGFs, VEGF, TGF-b1, TGF-b3, PDGF, …) - anti-inflammatory interleukins (IL-1ra, IL-4, IL-10, …) - interferons (IFN-g, …) In Vitro Activity Promotes proliferation of NHEK Promotes proliferation of NHDF Promotes collagen formation in NHDF Does not promote proliferation of SCC Does not interfere with the normal apoptotic process Clinical Data Post-wound healing Post-cosmetic procedure Skin rejuvenation

10. Potential Mechanisms of action of Human Fibroblast Lysate Cream (HFLC) in Lichen Sclerosus Inhibition of pro-inflammatory cytokines that are elevated in lichen sclerosus. Promotion of collagen formation. Additional wound healing properties of HFLC (promotion of growth of keratinocytes and fibroblasts).

11. Randomized placebo controlled study of HFCL for vulvar lichen sclerosus 30 subjects (15 cream with lysate [Active], 15 cream w/0 lysate [Placebo]); ; 12 weeks twice daily application Endpoints: Change in inflammation between pre-treatment and post-treatment biopsies as determined by two blinded dermatopathologists Investigator Global Assessment (IGA) Subjective improvement as measured by VAS of pruritus (VAS-PR) and burning/pain (VAS-BP)

12. RESULTS All 30 women completed the study without SAE. Significant Improvement in IGA, VAS-PR, and VAS-BP (P < 0.05) in women using HFCL from baseline to the end of the study. However, there was no difference between placebo and HFCL. No significant difference in inflammation between pre and post treatment biopsies. 60% of women using HFCL had an improvement in IGA but only 33% of woman using placebo had an improvement.

13. Results of women using HFCL Pre treatment Post treatment

14. Results of women using HFCL Pre treatment Post treatment

15. Results of women using HFCL Pretreatment Post treatment

16. Conclusions HFLC and placebo were well tolerated. There was clinical improvement in 60% the HFCL arm as compared to 33% in the placebo arm. This did not reach statistical significant. High placebo response due to a high quality emollient base. This exploratory study was inadequately powered. HFLC may be an adjunctive therapy, combined with high potency corticosteroids, for lichen sclerosus.

17. International Society for the Study of Women’s Sexual Health 2012 (ISSWSH.org) Jerusalem, Israel February 19 – 22, 2012