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Cutaneous Tolerability and Safety of NVN1000 Topical Gel in Healthy Volunteers

NCT01694810 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2020-01-30

No results posted yet for this study

Summary

The study will assess safety and tolerability of different doses of topical gel containing a new chemical entity, NVN1000, and the vehicle (gel without drug) applied to the face of healthy volunteers with high counts of Propionibacterium acnes. The test product will be applied once daily for 4 weeks. Exploratory measures include whether the topical product decreases the amount of a bacteria associated with acne (P. acnes).

Conditions

  • Acne Vulgaris

Interventions

DRUG

2% NVN1000 Topical Gel

2% NVN1000 Topical Gel once daily for 4 weeks

DRUG

4% NVN1000 Topical Gel

4% NVN1000 4% Topical Gel applied once daily 4 weeks

DRUG

8% NVN1000 Topical Gel

8% NVN1000 Topical Gel applied once daily for 4 weeks

DRUG

Vehicle Topical Gel

Vehicle Topical Gel applied once daily

Sponsors & Collaborators

  • Novan, Inc.

    lead INDUSTRY

Principal Investigators

  • James J Leyden, MD · KGL, Inc.

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2012-09-30
Primary Completion
2012-11-30
Completion
2012-11-30

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01694810 on ClinicalTrials.gov