A Phase 1, 3 Day Study of Safety and Tolerability 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

15 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-11-30

Study Completion Date

2012-12-31

Brief Summary

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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

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Detailed Description

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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.

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

NONE

Study Groups

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Topical Gel Vehicle

Once daily application of topical gel vehicle to forehead for 3 days

Group Type PLACEBO_COMPARATOR

Topical Gel Vehicle

Intervention Type DRUG

8% NVN1000 Topical Gel

Once daily application of 8% NVN1000 Topical Gel to the forehead for 3 days

Group Type ACTIVE_COMPARATOR

8% NVN1000 Topical Gel

Intervention Type DRUG

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

Group Type ACTIVE_COMPARATOR

8% NVN1000 Topical Gel and moisturizer

Intervention Type DRUG

Interventions

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Topical Gel Vehicle

Intervention Type DRUG

8% NVN1000 Topical Gel

Intervention Type DRUG

8% NVN1000 Topical Gel and moisturizer

Intervention Type DRUG

Other Intervention Names

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Vehicle NVN1000 Topical Gel NVN1000 plus moisturizer

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes