FDAnews
www.fdanews.com/articles/81004-barrier-therapeutics-reports-acne-medicine-trial-data

BARRIER THERAPEUTICS REPORTS ACNE MEDICINE TRIAL DATA

September 19, 2005

Barrier Therapeutics has reported positive Phase IIa data for its oral formulation of Rambazole in the treatment of moderate-to-severe acne and positive biological activity data for its topical formulation of Rambazole.

Rambazole is a novel retinoic acid metabolism-blocking agent. In the recently completed trial with an oral formulation of Rambazole, 17 subjects with moderate-to-severe acne were treated with 1 mg of oral Rambazole once daily for 12 consecutive weeks.

The results of this study indicate that 16 of 17 subjects (94 percent) experienced a reduction in total acne lesion count of more than 50 percent and six of 17 subjects (35 percent) were considered "cleared or almost cleared." To be considered "cleared or almost cleared" a subject must have had more than 90 percent reduction in total lesion count. Inflammatory and non-inflammatory lesions responded equally well to treatment. There were no serious treatment-related adverse effects reported. Non-serious side effects experienced by this patient group included some dryness of skin and lips.