The objective of this Phase II SBIR grant proposal is to demonstrate tolerability and efficacy of an ISW Group, Inc. topical dermatologic formulation developed for the treatment of the human skin disorder Pseudofolliculitis barbae (PFB). PFB is characterized by skin lesions (e.g. """"""""razor bumps""""""""), skin discoloration, and/or irritation. Pseudofolliculitis can affect almost anyone who shaves; however, the disease disproportionately affects African-American and Hispanic males. PFB is especially problematic for military personnel and first-line responders (e.g., police officers, firemen, hazmat and healthcare workers, etc.). These individuals may have open sores or lesions on the face and neck as a result of PFB which makes them more susceptible to infection or chemical and biological agents. The broad long term objectives of this study are to gain FDA approval and commercialize a therapeutic product for the management and treatment of PFB. To meet the objectives of this Phase II SBIR grant proposal, a randomized, placebo-controlled study will be conducted at two study sites. Subjects with PFB who meet eligibility requirements will be enrolled for up to seven weeks. Results will be assessed by the physician and the subject using quantitative and qualitative parameters. Successful outcomes of the proposed studies will advance ISW Group's topical dermatologic formulation along the regulatory approval process leading to commercialization. ? ? The research proposed in the Phase II SBIR application aims to develop an FDA approved topical product for management and treatment of Pseudofolliculitis barbae (PFB), a chronic inflammatory skin condition. Pseudofolliculitis barbae affects a large number of individuals who shave; however, it is particularly problematic for African-American and Hispanic males; and Caucasian males to a lesser degree. The development of a safe and effective topical product for PFB is likely to yield applications for other acute and chronic inflammatory skin conditions, thereby, further benefiting society as a whole. ? ? ?
