Cutaneous Tolerability and Safety of NVN1000 Topical Gel in Healthy Volunteers

A Phase 1 Multiple Dose, Single-Center, Observer-Blind Parallel Group Study Evaluating Safety and Cutaneous Tolerability of NVN1000 Topical Gel in Healthy Volunteers

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01694810

Enrollment

Registered

2012-09-27

Start date

2012-09-30

Completion date

2012-11-30

Last updated

2020-01-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Acne Vulgaris

Keywords

acne vulgaris

Brief 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).

Detailed description

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).

Interventions

DRUG2% NVN1000 Topical Gel

2% NVN1000 Topical Gel once daily for 4 weeks

DRUG4% NVN1000 Topical Gel

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

DRUG8% NVN1000 Topical Gel

8% NVN1000 Topical Gel applied once daily for 4 weeks

DRUGVehicle Topical Gel

Vehicle Topical Gel applied once daily

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

SINGLE (Investigator)

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Yes

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

Design outcomes

Primary

Measure	Time frame	Description
Cutaneous tolerability Evaluation	4 weeks	Cutaneous tolerability evaluations to include erythema, scaling, dryness, puritus and burning/stinging using a 4-category scale with scores ranging from 0-3 (0=none, 1=mild, 2=moderate, 3 - severe).

Secondary

Measure	Time frame	Description
Safety Assessment	4 weeks	Comparison of adverse events between groups.

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026