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Velac is an investigational new drug developed by that combines clindamycin 1% and tretinoin 0.025% in a gel formulation developed by Connectics as a potential new topical treatment for acne. This single formulation enhances compliance in young patients and improves the therapeutic results. Connetics has recently announced positive results from its Phase III clinical trials with Velac versus clindamycin gel and tretinoin gel for the treatment of acne. The topical prescription acne category is one of the largest segments in the United States dermatology market, and is estimated to exceed $1.2 billion per year. Approximately 17 million people in the United States have acne resulting in approximately 5.5 million office visits per year.
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Treatment with Velac was found to be more effective than tretinoin alone in inflamed lesions and at least similar in open and closed comedones. In two of the three studies on the whole acne severity grade was significantly more reduced when compared with tretinoin. Velac is also more effective than clindamycin alone in the treatment of non-inflamed lesions. In the two multicentre studies the reduction of the on the whole acne severity grade was also more favourable for the new gel formulation. A more rapid response occurred with Velac than with either component used alone.
This study was designed to assess whether the recently developed fixed formulation of 1.2% clindamycin phosphate and 0.025% tretinoin in a gel base (Velac), further referred to as Clindamycin phosphate Tretinoin Gel is at least as effective as a proprietary 0.025% tretinoin gel formulation showing an additional anti-inflammatory effect in the treatment of moderate to severe acne vulgaris.
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