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

Novan, Inc.153 enrolled

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.

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

153

Conditions

Acne Vulgaris

Interventions

NVN1000 1% GelDRUG

Twice daily NVN1000 1% Gel for 12 weeks

NVN1000 4% GelDRUG

Twice daily NVN1000 4% Gel for 12 weeks

Vehicle GelDRUG

Twice daily Vehicle Gel for 12 weeks

Eligibility

Sex: ALLMin age: 12 YearsMax age: 40 Years

Medical Language ↔ Plain English

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

Locations (3)

Instituto Dermatologico & Cirugia de Piel

Santo Domingo, Dominican Republic

Hospital Y Clinica Bendana

San Pedro Sula, Honduras

Hosptal Punta Pacifica

Panama City, Panama

Outcomes

Primary Outcomes

The absolute change from baseline in non-inflammatory lesion counts at Week 12

Time frame: 12 weeks

Secondary Outcomes

The absolute change from baseline in inflammatory lesion counts at Week 12

Time frame: 12 weeks

Success on the Investigator Global Assessment (IGA) at Week 12

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.

Time frame: 12 week

Data from ClinicalTrials.gov

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