Cutaneous Tolerability and Safety of NVN1000 Topical Gel in Healthy Volunteers

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-09-30

Study Completion Date

2012-11-30

Brief Summary

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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).

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Detailed Description

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This is a single center, observer blinded, randomized, multiple dose study with 3 doses of NVN1000 and vehicle applied once daily for 4 weeks. There are 4 arms to the study (3 active and 1 vehicle).

Conditions

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Acne Vulgaris

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Investigators

Study Groups

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2% NVN1000 Topical Gel

2% NVN1000 Topical Gel once daily for 4 weeks

Group Type EXPERIMENTAL

2% NVN1000 Topical Gel

Intervention Type DRUG

2% NVN1000 Topical Gel once daily for 4 weeks

4% NVN1000 Topical Gel

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

Group Type EXPERIMENTAL

4% NVN1000 Topical Gel

Intervention Type DRUG

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

Vehicle Topical Gel

Vehicle Topical Gel once daily for 4 weeks

Group Type PLACEBO_COMPARATOR

Vehicle Topical Gel

Intervention Type DRUG

Vehicle Topical Gel applied once daily

8% NVN1000 Topical Gel

8% NVN1000 8% Topical Gel applied once daily for 4 weeks

Group Type EXPERIMENTAL

8% NVN1000 Topical Gel

Intervention Type DRUG

8% NVN1000 Topical Gel applied once daily for 4 weeks

Interventions

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2% NVN1000 Topical Gel

2% NVN1000 Topical Gel once daily for 4 weeks

Intervention Type DRUG

4% NVN1000 Topical Gel

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

Intervention Type DRUG

8% NVN1000 Topical Gel

8% NVN1000 Topical Gel applied once daily for 4 weeks

Intervention Type DRUG

Vehicle Topical Gel

Vehicle Topical Gel applied once daily

Intervention Type DRUG

Other Intervention Names

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NVN1000 NVN1000 NVN1000 Vehicle

Eligibility Criteria

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Inclusion Criteria

* Healthy male and female volunteers
* Age 18 or older
* High degree of fluorescence of facial skin under Wood's lamp

Exclusion Criteria

* Acute or chronic skin disorders
* Use of topical or systemic antibiotics within 4 weeks of study
* Concomitant use of nitroglycerin or other nitric oxide donor drugs
* Females who are pregnant, planning pregnancy or breast feeding

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes