Safety and efficacy of human fibroblast lysate cream for vulvar lichen sclerosus: a randomized placebo-controlled trial.

© 2015 The Authors. doi: 10.2340/00015555-2052 Journal Compilation © 2015 Acta Dermato-Venereologica. ISSN 0001-5555 Lichen sclerosus (LS) is a chronic inflammatory disorder that predominantly affects the anogenital skin. It has been estimated that it affects one in 60 women (1). Typical vulvar LS lesions are white plaques with areas of focal purpura, excoriation, and erosions (2). Frequently accompanying these lesions are architectural changes of the vulva, including scaring of the clitoral prepuce (phimosis), resorption of the labia minora, and narrowing of the introitus. Moreover, 4–6% of women with vulvar LS develop squamous cell carcinoma (SCC) (3). Histo­ pathological changes of LS include hyperkeratosis of the epidermis, epidermal atrophy with loss of rete ridges, homogenization of collagen in the upper dermis, and a lichenoid (band­like) inflammatory infiltrate in the dermis (2). Vulvar LS has also been associated with circulating auto­antibodies to endothelial cell adhesion molecules (ECAM­1) and to bullous pemphigoid antigens BP180 and BP230 (4, 5). Currently, the gold standard for treatment for vulvar LS is application of ultra­potent topical corticosteroid such as clobetasol propionate. Corticosteroids have repeatedly been shown to be safe and effective in the treatment of LS leading to a significant resolution of hyperkeratosis, purpura, fissures, and erosions (6, 7, 8). Furthermore, preliminary data indicate that the risk of malignant transformation may also decline with corticosteroid use (3, 9, 10). However, long­term use of corticosteroids may be associated with serious systemic and local side effects, including dermal thickening, skin atrophy, superimposed infections, rebound dermatitis, and adrenal insufficiency (11–13). Hence, it would be beneficial if there were an effective alternative to corticosteroids for the treatment of vulvar LS. Human fibroblast lysate cream (HFLC), also known as cutaneous lysate (Neogyn creamTM, Neogyn, Inc Jersey City, New Jersey, USA), which is obtained from cultured human fetal fibroblasts, has been shown to contain anti­inflammatory cytokines including interleukin (IL) 1 receptor antagonist (IL­1ra), IL­10, and IL­13, as well as wound­healing growth factors EGF, FGFs and VEGF which could potentially participate in anti­inflammatory activity. HFLC does not promote the proliferation of SCC nor does it interfere with the normal apoptotic processes in vitro (14). Recently, a placebo­controlled crossover study indicated that the HFLC reduces symptoms of provoked vestibulodynia, another inflammatory condition of the vulva (15). Therefore, this pilot study was designed to further evaluate the safety and efficacy of HFLC in patients with vulvar LS.