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

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.

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.

Study Overview

• Status: Completed
• Conditions: Acne Vulgaris
• Intervention / Treatment: Drug: NVN1000 1% Gel; Drug: NVN1000 4% Gel; Drug: Vehicle Gel

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 Type: Interventional
• Enrollment (Actual): 153
• Phase: Phase 2

Contacts and Locations

Study Locations

• Dominican Republic
  • Santo Domingo, Dominican Republic
    • Instituto Dermatologico & Cirugia de Piel
• Honduras
  • San Pedro Sula, Honduras
    • Hospital y Clinica Bendana
• Panama
  • Panama City, Panama
    • Hosptal Punta Pacifica

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 12 years to 40 years (Child, Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: NVN1000 1% Gel; NVN1000 1% Gel twice daily	Drug: NVN1000 1% Gel; Twice daily NVN1000 1% Gel for 12 weeks; Other Names: NVN1000
Experimental: NVN1000 4% Gel; NVN1000 4% Gel twice daily	Drug: NVN1000 4% Gel; Twice daily NVN1000 4% Gel for 12 weeks; Other Names: NVN1000
Placebo Comparator: Vehicle Gel; Vehicle Gel twice daily	Drug: Vehicle Gel; Twice daily Vehicle Gel for 12 weeks; Other Names: Comparator Gel

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The absolute change from baseline in non-inflammatory lesion counts at Week 12	The absolute change from baseline in non-inflammatory lesion counts at Week 12	12 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The absolute change from baseline in inflammatory lesion counts at Week 12	The absolute change from baseline in inflammatory lesion counts at Week 12	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.	12 week

Collaborators and Investigators

• Sponsor: Novan, Inc.

Publications and helpful links

General Publications

• Baldwin H, Blanco D, McKeever C, Paz N, Vasquez YN, Quiring J, Enloe C, De Leon E, Stasko N. Results of a Phase 2 Efficacy and Safety Study with SB204, an Investigational Topical Nitric Oxide-releasing Drug for the Treatment of Acne Vulgaris. J Clin Aesthet Dermatol. 2016 Aug;9(8):12-8. Epub 2016 Aug 1.

Study record dates

Study Major Dates

• Study Start: April 1, 2013
• Primary Completion (Actual): November 1, 2013
• Study Completion (Actual): November 1, 2013

Study Registration Dates

• First Submitted: April 29, 2013
• First Submitted That Met QC Criteria: April 29, 2013
• First Posted (Estimate): May 1, 2013

Study Record Updates

• Last Update Posted (Actual): November 19, 2018
• Last Update Submitted That Met QC Criteria: November 15, 2018
• Last Verified: November 1, 2018

More Information

Terms related to this study

• Keywords: acne
• Additional Relevant MeSH Terms: Skin Diseases; Acneiform Eruptions; Sebaceous Gland Diseases; Acne Vulgaris
• Other Study ID Numbers: NI-AC201