A Phase 2, 3 Arm Study of NVN1000 Gel and Vehicle Gel in Subjects With Acne

A Multi-Center, Randomized, Evaluator-Blinded, Vehicle-Controlled, Parallel Group, 3-arm Study Comparing the Efficacy, Tolerability and Safety of 2 Concentrations of NVN1000 Gel and Vehicle Gel Twice Daily in the Treatment of Acne Vulgaris.

This is a 12 week clinical trial in subjects with acne vulgaris. Subjects will be randomized to NVN1000 1% Gel, NVN1000 4% Gel or Vehicle Gel twice daily. Safety, tolerability and efficacy will be assessed over the course of the study.

This is a multi-center, evaluator and subject blinded, randomized, vehicle-controlled, parallel group, dose-ranging study to be conducted in approximately 150 subjects with acne vulgaris. Subjects who satisfy the entry criteria at the Baseline visit will be randomized to NVN1000 1% Gel, NVN1000 4% Gel or Vehicle Gel in a 1:1:1 ratio. Efficacy assessments will include inflammatory and non-inflammatory lesion counts and investigator global assessments (IGA). Tolerability and safety assessments include cutaneous tolerability evaluation, adverse event collection, physical exams, and laboratory studies. Subjects will return for post-baseline evaluation at Weeks 2, 4, 8, and 12.

Inclusion Criteria:

• Subjects with acne vulgaris and at least 20 but no more than 40 inflammatory lesions, 25-70 non-inflammatory lesions, no more than 2 nodules on the face
• Baseline IGA score of mild, moderate or severe
• Women of child-bearing potential must agree to use an effective method of birth control during the study and for 30 days after their final study visit

Exclusion Criteria:

• Any dermatologic condition or other medical problem that could interfere with clinical evaluation or requires the use of topical or systemic therapy that make evaluations and lesion count inconclusive
• Female subjects who are pregnant, nursing, or considering becoming pregnant
• Methemoglobin > 2% at baseline
• Clinically significant anemia at baseline
• Use of topical or systemic medications to treat acne
• Use of medications that make acne worse, associated with methemoglobinemia, or nitric oxide donors