NCT01844752

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.

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 153 (actual)
• Sponsor: Novan, Inc. · Industry
• Sex: All
• Age: 12 Years – 40 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Acne Vulgaris

Interventions

Type	Name	Description
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

Timeline

• Start date: 2013-04-01
• Primary completion: 2013-11-01
• Completion: 2013-11-01
• First posted: 2013-05-01
• Last updated: 2018-11-19

Locations

3 sites across 3 countries: Dominican Republic, Honduras, Panama