A Phase 2, 3 Arm Study of NVN1000 Gel and Vehicle Gel in Subjects With Acne

Study Overview
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Brief Summary
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This is a 12 week clinical trial in subjects with acne vulgaris. Subjects will be randomized to NVN1000 1% Gel, NVN1000 4% Gel or Vehicle Gel twice daily. Safety, tolerability and efficacy will be assessed over the course of the study.

Detailed Description
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This is a multi-center, evaluator and subject blinded, randomized, vehicle-controlled, parallel group, dose-ranging study to be conducted in approximately 150 subjects with acne vulgaris. Subjects who satisfy the entry criteria at the Baseline visit will be randomized to NVN1000 1% Gel, NVN1000 4% Gel or Vehicle Gel in a 1:1:1 ratio. Efficacy assessments will include inflammatory and non-inflammatory lesion counts and investigator global assessments (IGA). Tolerability and safety assessments include cutaneous tolerability evaluation, adverse event collection, physical exams, and laboratory studies. Subjects will return for post-baseline evaluation at Weeks 2, 4, 8, and 12.

Official Title
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A Multi-Center, Randomized, Evaluator-Blinded, Vehicle-Controlled, Parallel Group, 3-arm Study Comparing the Efficacy, Tolerability and Safety of 2 Concentrations of NVN1000 Gel and Vehicle Gel Twice Daily in the Treatment of Acne Vulgaris.

Conditions
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Acne Vulgaris

Intervention / Treatment
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* Drug: NVN1000 1% Gel
* Drug: NVN1000 4% Gel
* Drug: Vehicle Gel


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Subjects with acne vulgaris and at least 20 but no more than 40 inflammatory lesions, 25-70 non-inflammatory lesions, no more than 2 nodules on the face Baseline IGA score of mild, moderate or severe Women of child-bearing potential must agree to use an effective method of birth control during the study and for 30 days after their final study visit Exclusion Criteria: Any dermatologic condition or other medical problem that could interfere with clinical evaluation or requires the use of topical or systemic therapy that make evaluations and lesion count inconclusive Female subjects who are pregnant, nursing, or considering becoming pregnant Methemoglobin > 2% at baseline Clinically significant anemia at baseline Use of topical or systemic medications to treat acne Use of medications that make acne worse, associated with methemoglobinemia, or nitric oxide donors

Ages Eligible for Study
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Minimum Age: 12 Years
Maximum Age: 40 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

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 1% Gel<br>NVN1000 1% Gel twice daily | Drug: NVN1000 1% Gel<br>* Twice daily NVN1000 1% Gel for 12 weeks<br>* Other names: NVN1000;|
| Experimental: NVN1000 4% Gel<br>NVN1000 4% Gel twice daily | Drug: NVN1000 4% Gel<br>* Twice daily NVN1000 4% Gel for 12 weeks<br>* Other names: NVN1000;|
| Placebo Comparator: Vehicle Gel<br>Vehicle Gel twice daily | Drug: Vehicle Gel<br>* Twice daily Vehicle Gel for 12 weeks<br>* Other names: Comparator Gel;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The absolute change from baseline in non-inflammatory lesion counts at Week 12 | The absolute change from baseline in non-inflammatory lesion counts at Week 12 | 12 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The absolute change from baseline in inflammatory lesion counts at Week 12 | The absolute change from baseline in inflammatory lesion counts at Week 12 | 12 weeks | 
| Success on the Investigator Global Assessment (IGA) at Week 12 | Analysis of the dichotomized IGA scores (success vs failure) at Week 12. Success is defined as a score of clear or almost clear and a 2 point improvement in the IGA score from Baseline. | 12 week | 

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