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

Overview

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 Title of Study: “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.”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: Double (Participant, Investigator)
  • Study Primary Completion Date: November 2013

Detailed 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.

Interventions

  • Drug: NVN1000 1% Gel
    • Twice daily NVN1000 1% Gel for 12 weeks
  • Drug: NVN1000 4% Gel
    • Twice daily NVN1000 4% Gel for 12 weeks
  • Drug: Vehicle Gel
    • Twice daily Vehicle Gel for 12 weeks

Arms, Groups and Cohorts

  • Experimental: NVN1000 1% Gel
    • NVN1000 1% Gel twice daily
  • Experimental: NVN1000 4% Gel
    • NVN1000 4% Gel twice daily
  • Placebo Comparator: Vehicle Gel
    • Vehicle Gel twice daily

Clinical Trial Outcome Measures

Primary Measures

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

Secondary Measures

  • The absolute change from baseline in inflammatory lesion counts at Week 12
    • Time Frame: 12 weeks
    • The absolute change from baseline in inflammatory lesion counts at Week 12
  • Success on the Investigator Global Assessment (IGA) at Week 12
    • Time Frame: 12 week
    • Analysis of the dichotomized IGA scores (success vs failure) at Week 12. “Success” is defined as a score of “clear” or “almost clear” and a 2 point improvement in the IGA score from Baseline.

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: 12 Years

Maximum Age: 40 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Novan, Inc.
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Joyce Rico, MD, Study Director, Novan, Inc.

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