VYNE - VYNE Therapeutics highlights initiation of AMZEEQ acne trial

VYNE Therapeutics (VYNE) announces the initiation of an investigator initiated trial evaluating the safety and efficacy of AMZEEQ (minocycline) topical foam, 4%, as a companion treatment with oral isotretinoin in patients with moderate to severe acne.The trial is a randomized, multicenter, evaluator-blinded, study to evaluate the safety, tolerability, and efficacy over a 20-week treatment period of oral isotretinoin and AMZEEQ concomitant use compared to oral isotretinoin only in the treatment of patients with moderate to severe acne vulgaris.The efficacy endpoints are percent change from baseline in inflammatory and comedonal lesion counts at each visit, and IGA Treatment Success at each visit, where success is defined as an IGA score of 0 or 1, and at least a 2-grade improvement (decrease) from Baseline.The planned enrollment is about 30 patients to be enrolled from two sites in the United States.Shares down more than 2% premarket.

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VYNE Therapeutics highlights initiation of AMZEEQ acne trial