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

Novan

Status and phase: Completed; Phase 2

Conditions: Acne Vulgaris

Treatments: Drug: NVN1000 4% Gel; Drug: NVN1000 1% Gel; Drug: Vehicle Gel

Study type: Interventional

Funder types: Industry

Identifiers

NCT01844752

NI-AC201

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 153 patients

Sex: All

Ages: 12 to 40 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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153 participants in 3 patient groups, including a placebo group

NVN1000 1% Gel

Experimental group

Description:

NVN1000 1% Gel twice daily

Treatment:

Drug: NVN1000 1% Gel

NVN1000 4% Gel

Experimental group

Description:

NVN1000 4% Gel twice daily

Treatment:

Drug: NVN1000 4% Gel

Vehicle Gel

Placebo Comparator group

Description:

Vehicle Gel twice daily

Treatment:

Drug: Vehicle Gel