Vicept Therapeutics, Inc. announced positive study results from a Phase 2 clinical trial evaluating the dose-response relationship of four concentrations of V-101 cream, a topical cream for the treatment of Type I Rosacea (Erythematotelangiectatic Rosacea). The results demonstrated a statistically significant (p=0.0006) improvement in the primary end point, which was a reduction in facial erythema, over an eight hour period in patients with erythematotelangiectatic rosacea (ETR), versus placebo. Further, V-101 demonstrated a safety profile similar to placebo cream and no evidence of “rebound” or tachyphylaxis was observed.
“These positive data showed that V-101 significantly reduced the redness associated with Type I rosacea (ETR) and demonstrated a favorable side effect profile, further confirming its potential to be the first effective topically applied therapy directed specifically toward the erythema of rosacea,” said Dr. Neal Walker, President and Chief Executive Officer of Vicept. “This is a major milestone for the Company and we are poised and committed to continue the advancement of the V-101 development program.”
Study V-101-ROSE-202 is a prospectively randomized, multi-centered, double-blinded, placebo-controlled, Phase 2 clinical trial designed to evaluate the dose-response relationship of four concentrations of V-101 cream vs. vehicle (placebo) for the treatment of the erythema associated with rosacea. A total of 183 patients with moderate to severe erythema participated at seven investigational centers across the United States. Patients were divided among five groups and self-administered one of four concentrations of V-101 cream or vehicle (placebo) cream once daily for 28 days. The study also demonstrated that V-101 cream was well-tolerated in these patients, a population of patients with facial skin that is highly sensitive to topical preparations. The safety profile of all the active preparations was similar to that of placebo.
Date: January 10, 2011
Source: Vicept Therapeutics, Inc.
Filed Under: Drug Discovery