Cutaneous Tolerability and Safety of NVN1000 Topical Gel in Healthy Volunteers

Study Overview
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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).

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).

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

Conditions
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Acne Vulgaris

Intervention / Treatment
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* Drug: 2% NVN1000 Topical Gel
* Drug: 4% NVN1000 Topical Gel
* Drug: 8% NVN1000 Topical Gel
* Drug: Vehicle Topical Gel


Participation Criteria
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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

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: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 2% NVN1000 Topical Gel<br>2% NVN1000 Topical Gel once daily for 4 weeks | Drug: 2% NVN1000 Topical Gel<br>* 2% NVN1000 Topical Gel once daily for 4 weeks<br>* Other names: NVN1000;|
| Experimental: 4% NVN1000 Topical Gel<br>4% NVN1000 4% Topical Gel once daily for 4 weeks | Drug: 4% NVN1000 Topical Gel<br>* 4% NVN1000 4% Topical Gel applied once daily 4 weeks<br>* Other names: NVN1000;|
| Placebo Comparator: Vehicle Topical Gel<br>Vehicle Topical Gel once daily for 4 weeks | Drug: Vehicle Topical Gel<br>* Vehicle Topical Gel applied once daily<br>* Other names: Vehicle;|
| Experimental: 8% NVN1000 Topical Gel<br>8% NVN1000 8% Topical Gel applied once daily for 4 weeks | Drug: 8% NVN1000 Topical Gel<br>* 8% NVN1000 Topical Gel applied once daily for 4 weeks<br>* Other names: NVN1000;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cutaneous tolerability Evaluation | 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). | 4 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety Assessment | Comparison of adverse events between groups. | 4 weeks | 
| Safety Assessment | Change from baseline in HCT (L/L) | 4 weeks | 
| Safety Assessment | Change from baseline in HGB, MCHC (g/L) | 4 weeks | 
| Safety Assessment | Change from baseline in % methemoglobin (%) | 4 weeks | 
| Safety Assessment | Change from baseline in % Basophils (%) | 4 weeks | 
| Safety Assessment | Change from baseline in % Eosinophils (%) | 4 weeks | 
| Safety Assessment | Change from baseline in % Lymphocytes (%) | 4 weeks | 
| Safety Assessment | Change from baseline in MCH (pg) | 4 weeks | 
| Safety Assessment | Change from baseline in MCV, MPV (fL) | 4 weeks | 
| Safety Assessment | Change from baseline in % Monocytes (%) | 4 weeks | 
| Safety Assessment | Change from baseline in % Neutrophils (%) | 4 weeks | 
| Safety Assessment | Change from baseline in Platelet Count, WBC (10 ^ 9/L) | 4 weeks | 
| Safety Assessment | Change from baseline in % RDW (%) | 4 weeks | 
| Safety Assessment | Change from baseline in RBC (10 ^ 12/L) | 4 weeks | 
| Safety Assessment | Change from baseline in Albumin, Protein, Total (g/L) | 4 weeks | 
| Safety Assessment | Change from baseline in Alkaline Phosphatase, ALT, AST, (U/L) | 4 weeks | 
| Safety Assessment | Change from baseline in Bicarbonate, Bun, Calcium, Chloride, Glucose, Phosphorus, Potassium, Sodium (mmol/L) | 4 weeks | 
| Safety Assessment | Change from baseline in Bilirubin Direct, Bilirubin Total, Creatinine (umol/ L) | 4 weeks | 

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