Clinical, Cosmetic and Investigational Dermatology 2015:8 179–185

A.Sparavigna, B.Tenconi, I.De Ponti, L.La Penna

Abstract: Acne is characterized by primary lesions on the face, chest, and back, and by a variety of other signs and symptoms. In particular, acne inflammatory lesions result from Propionibacterium acnes colonization and are of particular relevance as they can cause permanent scarring. Acne also causes significant psychological morbidity in affected patients. Products currently available for the treatment of acne include systemic and topical treatments. As these products can cause severe side effects, new, innovative therapies are needed. Farmaka Acne Cream (FAC) is a novel, film-forming cream developed to treat mild and moderate acne. In vitro studies have demonstrated that FAC is as effective as 5% benzoyl peroxide in inhibiting growth of P. acnes. In 32 subjects with mild or moderate acne, FAC reduced all the major signs and symptoms of the disease. These included itching, erythema, and scaling, as well as reductions in the numbers of papules, pustules, and open and closed comedones. Acne severity improved in 38% of subjects, while none worsened.

FAC was found to be effective in controlling sebum secretion, and was non-comedogenic. Most subjects (90%) reported tolerability as good or very good, while clinical efficacy and cosmetic acceptability were judged as good. For assessment of contact sensitization and photosensitization, FAC was applied daily to the backs of 29 subjects in two symmetric areas for 10 days. Using a solar stimulator, one minimal erythema dose was delivered to one side of the back from days 11 to 13. The four different subareas of treated/untreated and irradiated/nonirradiated and combinations thereof were compared. No cases of contact sensitization or photosensitization were observed, and FAC is considered safe for use in intense sunlight. In vitro and in vivo studies provide evidence for the safety and clinical benefits of FAC, a promising candidate for the treatment of mild and moderate acne.