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news.Vicept Therapeutics has reported positive results from a second Phase II clinical trial of V-101 cream, a topical cream for the treatment of Type I Rosacea (Erythematous Rosacea).
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Study of V-101 is a randomized, multi-centered, double-blinded, vehicle-controlled, Phase II clinical trial designed to evaluate the dose-response relationship of two concentrations of V-101 cream vs. vehicle (placebo).
The results demonstrated a statistically significant improvement (p= <0.01) in the primary endpoint, a reduction in facial erythema or redness, over a 12 hour period versus placebo cream in patients with erythematous rosacea.
Vicept president and CEO Neal Walker said this study was designed to optimize the concentration of V-101 cream in preparation for Phase III clinical testing in patients with erythematous rosacea and to further characterize the duration of the clinical effect.
"In addition to the favorable dose-response results, the data also demonstrated a statistically significant outcome (p = <0.05) in the anticipated Phase III primary end point of a two ordinal reduction in the combined clinician and patient assessments," Walker said.