Summary:
Clinical Research of Homestead is conducting a Phase 3 Multi-Center, Randomized, Double-Blinded, Vehicle-Controlled, Parallel Group Study Comparing the Efficacy, Tolerability and Safety of a NVN1000 Gel and Hydrogel vs Vehicle Gel Once Daily in the Treatment of Acne Vulgaris
Qualified Participants Must:
• Have a signed written informed consent form (ICF). Subjects less than 18 years of age or the age of majority in their state must sign an assent form for the study and a parent or a legal guardian must sign the informed consent
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Be male or female, 9 years of age or older, inclusive at Baseline and in good general health
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Have a Baseline IGA score of (3) moderate or (4) severe
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Have a minimum of 25 but not more than 70 non-inflammatory lesions (open and closed comedones) on the face at Baseline
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Have a minimum of 20 but no more than 40 inflammatory lesions (papules and pustules) on the face at Baseline
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Have no more than two nodules or cysts on the face at Baseline
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WOCBP must have a negative urine pregnancy test (UPT) prior to randomization
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WOCBP must agree to use an effective method of birth control during the course of the study and for 30 days after their final study visit
• females taking hormonal contraceptives must have taken the same type for at least three months (90 days) prior to entering the study and must not change type during the study. Those who have used hormonal contraceptives in the past and stopped must have discontinued usage at least three months prior to the start of the study
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Be willing and able to follow study instructions and likely to complete all study requirements. Subjects under 18 years of age or age of majority must be accompanied by the parent or legal guardian at the time of assent/consent signing
Qualified Participants May Receive:
Study Evaluations, Study medication and Compensation for time and travel