A Phase 1 Study Evaluating Safety and Tolerability of NVN1000 Gel

Study Overview
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Brief Summary
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This is a 2 week Phase 1 study of SB204 (NVN1000 Gel) in healthy adult volunteers with elevated Propionibacterium acnes (P. acnes) counts. Subjects will apply NVN1000 4% Gel or Vehicle Gel twice daily to their face. Assessments will include cutaneous tolerability, safety, and P. acnes counts.

Detailed Description
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In this single-center, vehicle gel-controlled, evaluator and subject blinded study, approximately 30 otherwise healthy adult subjects with elevated P. acnes counts will be randomized 2:1 to NVN1000 4% Gel or Vehicle Gel. The subjects will apply the test material twice daily to their face after washing. Subjects will be seen daily at the skin study center during the week and will apply their evening and weekend dose at home. Cutaneous tolerability will be assessed by the Investigator at Baseline, Week 1, and Week 2. Safety assessments include collection of adverse events, laboratory results, and clinically significant changes in physical examination. P. acnes counts will be obtained at Baseline, Week 1 and Week 2.

Official Title
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A Phase 1, Multiple-dose, Evaluator-blind, Randomized, Parallel Group Study Evaluating the Safety and Cutaneous Tolerability of SB204 (NVN1000 Gel) in Healthy Volunteers

Conditions
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Acne Vulgaris

Intervention / Treatment
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* Drug: NVN1000 4% Gel
* Drug: Vehicle Gel


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Healthy adult male or female volunteers If a woman of child-bearing potential, agrees to use effective method of birth control during the study and for 30 days after the final study visit Agree to refrain from use of antimicrobial topical products during study Exclusion Criteria: Any skin disorders of acute or chronic nature including psoriasis, eczema, etc Female subjects who are pregnant, nursing, or planning to become pregnant Subjects who have used topical or systemic antibiotics, estrogens, drugs associated with methemoglobinemia, nitrate donors Subjects with baseline methemoglobin > 2% Subjects with clinically significant anemia

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: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: NVN1000 4% Gel<br>NVN1000 4% Gel twice daily to the face for 2 weeks | Drug: NVN1000 4% Gel<br>* Applied topically twice daily<br>* Other names: SB204;|
| Placebo Comparator: Vehicle Gel<br>Vehicle Gel twice daily to the face for 2 weeks | Drug: Vehicle Gel<br>* Applied topically twice daily<br>* Other names: Placebo;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Tolerability based on the cutaneous tolerability scores | Cutaneous tolerability assessments (erythema, scaling, dryness, pruritus, burning/stinging) will be summarized with frequency counts and percentages at each score category for Week 1 and Week 2. | 2 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety which includes reported adverse events, clinically significant changes in physical exam, and labs | Adverse events will be summarized by treatment group. Clinically significant changes in physical examination, including vital signs, over the treatment period will be reported as adverse events. Changes in laboratory results will be analyzed. | 2 weeks | 

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