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

Study Overview
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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

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.

Official Title
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A Phase One, Single-Center, Open-Label, Randomized, Parallel Group, 3 Day Study Evaluating the Safety and Cutaneous Tolerability of NVN10000 Topical Gel in Healthy Volunteers

Conditions
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Acne Vulgaris

Intervention / Treatment
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* Drug: Topical Gel Vehicle
* Drug: 8% NVN1000 Topical Gel
* Drug: 8% NVN1000 Topical Gel and moisturizer


Participation Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Topical Gel Vehicle<br>Once daily application of topical gel vehicle to forehead for 3 days | Drug: Topical Gel Vehicle<br> <br> * Other names: Vehicle;|
| Active Comparator: 8% NVN1000 Topical Gel<br>Once daily application of 8% NVN1000 Topical Gel to the forehead for 3 days | Drug: 8% NVN1000 Topical Gel<br> <br> * Other names: NVN1000 Topical Gel;|
| Active Comparator: 8% NVN1000 Topical Gel and moisturizer<br>Once daily application of 8% NVN1000 Topical Gel to the forehead, followed 15 minutes later by application of a commercially available moisturizer | Drug: 8% NVN1000 Topical Gel and moisturizer<br> <br> * Other names: NVN1000 plus moisturizer;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cutaneous tolerability | Tolerability based on a four point scale (0-3) for erythema, scaling ,dryness, pruritus, and burning/stinging. | 3 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety comparison | Assess safety through the comparison of adverse events between groups (lab assessments, physical exams and vital signs). | 3 Days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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acne