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

Phase 2

Completed

• Conditions: Acne Vulgaris
• Interventions: Drug: NVN1000 1% Gel; Drug: NVN1000 4% Gel; Drug: Vehicle Gel

• Registration Number: NCT01844752
• Lead Sponsor: Novan, Inc.

Brief Summary

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.

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.

Study Timeline

• Study Start: 2013-04
• Study First Submitted: 2013-04-29
• Study First Submitted QC: 2013-04-29
• Study First Posted: 2013-05-01
• Primary Completion: 2013-11
• Study Completion: 2013-11
• Status Verified: 2018-11
• Last Update Submitted: 2018-11-15
• Last Update Posted: 2018-11-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 153

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
NVN1000 1% Gel	NVN1000 1% Gel	NVN1000 1% Gel twice daily
NVN1000 4% Gel	NVN1000 4% Gel	NVN1000 4% Gel twice daily
Vehicle Gel	Vehicle Gel	Vehicle Gel twice daily

Primary Outcome Measures

Name	Time	Method
The absolute change from baseline in non-inflammatory lesion counts at Week 12	12 weeks	The absolute change from baseline in non-inflammatory lesion counts at Week 12

Secondary Outcome Measures

Name	Time	Method
The absolute change from baseline in inflammatory lesion counts at Week 12	12 weeks	The absolute change from baseline in inflammatory lesion counts at Week 12
Success on the Investigator Global Assessment (IGA) at Week 12	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.

Trial Locations

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