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

• Register: ClinicalTrials.gov
• Last refreshed on: 12 December 2020
• Main ID: NCT01844752
• Date of registration: 29/04/2013
• Prospective Registration: No
• Primary sponsor: Novan, Inc.
• Public title: A Phase 2, 3 Arm Study of NVN1000 Gel and Vehicle Gel in Subjects With Acne
• Scientific title: 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.
• Date of first enrolment: April 2013
• Target sample size: 153
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT01844752
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Double (Participant, Investigator).
• Phase: Phase 2

Countries of recruitment

Dominican Republic, Honduras, Panama

Contacts

• Name: Joyce Rico, MD
• Affiliation: Novan, Inc.

Key inclusion & exclusion criteria

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



Age minimum: 12 Years
Age maximum: 40 Years
Gender: All

Health Condition(s) or Problem(s) studied

Acne Vulgaris

Intervention(s)

Drug: Vehicle Gel

Drug: NVN1000 1% Gel

Drug: NVN1000 4% Gel

Primary Outcome(s)

The absolute change from baseline in non-inflammatory lesion counts at Week 12 [Time Frame: 12 weeks]

Secondary Outcome(s)

Success on the Investigator Global Assessment (IGA) at Week 12 [Time Frame: 12 week]

The absolute change from baseline in inflammatory lesion counts at Week 12 [Time Frame: 12 weeks]

Secondary ID(s)

NI-AC201

Source(s) of Monetary Support

Please refer to primary and secondary sponsors