A Phase 1, 3 Day Study of Safety and Tolerability of NVN1000 Topical Gel in Healthy Volunteers

Phase 1

Completed

• Conditions: Acne Vulgaris
• Interventions: Drug: Topical Gel Vehicle; Drug: 8% NVN1000 Topical Gel; Drug: 8% NVN1000 Topical Gel and moisturizer

• Registration Number: NCT01755247
• Lead Sponsor: Novan, Inc.

Brief Summary

A Phase I, Single-Center, Open-Label, Randomized, Parallel Group, 3 Day Study Evaluating the Safety and Cutaneous Tolerability of NVN1000 Topical Gel in Healthy Volunteers

Detailed Description

This is a 3 day study to assess safety and tolerability of a new topical gel product, NVN1000 with and without the application of a commercially available moisturizer in approximately 15 healthy subjects. The test product will be applied to the forehead of healthy volunteers once daily for 3 days. One group of subjects will have a moisturizer applied to the same area 15 minutes after the test gel was applied and one group of subjects will be treated with the gel vehicle which does not contain the active product. The hypothesis is that the application of moisturizer will not effect safety or local tolerability.

Study Timeline

• Study Start: 2012-11
• Primary Completion: 2012-11
• Study Completion: 2012-12
• Study First Submitted: 2012-12-18
• Study First Submitted QC: 2012-12-18
• Study First Posted: 2012-12-24
• Status Verified: 2019-05
• Last Update Submitted: 2019-09-09
• Last Update Posted: 2019-09-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 15

Inclusion Criteria

• Healthy Male and Females > 18 years of age
• High degree of fluorescence of facial skin under Wood's lamp

Exclusion Criteria

• Acute or chronic skin disorders
• Topical or systemic antibiotics within 4 weeks of study enrollment
• Use of medication that increases risk of methemoglobinemia or influences P. acnes counts
• Subjects with medical illnesses, anemia, elevated methemoglobin
• Women who are pregnant, nursing or planning a pregnancy

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Topical Gel Vehicle	Topical Gel Vehicle	Once daily application of topical gel vehicle to forehead for 3 days
8% NVN1000 Topical Gel	8% NVN1000 Topical Gel	Once daily application of 8% NVN1000 Topical Gel to the forehead for 3 days
8% NVN1000 Topical Gel and moisturizer	8% NVN1000 Topical Gel and moisturizer	Once daily application of 8% NVN1000 Topical Gel to the forehead, followed 15 minutes later by application of a commercially available moisturizer

Primary Outcome Measures

Name	Time	Method
Cutaneous tolerability	3 days	Tolerability based on a four point scale (0-3) for erythema, scaling ,dryness, pruritus, and burning/stinging.

Secondary Outcome Measures

Name	Time	Method
Safety comparison	3 Days	Assess safety through the comparison of adverse events between groups (lab assessments, physical exams and vital signs).

Trial Locations

Locations (1)

KGL, Inc; 🇺🇸 Broomall, Pennsylvania, United States