P3 Study in Acne Comparing Once Daily SB204 and Vehicle

Study Overview
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Brief Summary
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This is a 12 week, multi-center, double-blinded, randomized, vehicle-controlled, parallel group, study to be conducted in approximately 1300 subjects with acne vulgaris in the US.

Detailed Description
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This is a double-blind, placebo controlled study in subjects with moderate to severe acne. Subjects who satisfy the entry criteria will be randomized to SB204 4% QD or Vehicle Gel QD in a 1:1 ratio. Efficacy assessments will include Investigator Global Assessments (IGA) and inflammatory and non-inflammatory lesion counts. Subjects will return for post-Baseline evaluation at Weeks 2, 4, 8, and 12/Early Termination (ET).

Official Title
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A Phase 3 Multi-Center, Randomized, Double-Blinded, Vehicle-Controlled, Parallel Group Study Comparing the Efficacy, Tolerability and Safety of SB204 and Vehicle Gel Once Daily in the Treatment of Acne Vulgaris

Conditions
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Acne Vulgaris

Intervention / Treatment
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* Drug: SB204 4%
* Drug: Vehicle Gel


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Moderate to severe acne Minimum of 25 and no more than 70 non-inflammatory lesions (open and closed comedones) on the face Minimum of 20 and no more than 40 inflammatory lesions (papules and pustules) Exclusion Criteria: Women of child-bearing potential who are pregnant, nursing, considering becoming pregnant Any dermatologic condition that could interfere with clinical evaluations including severe, recalcitrant cystic acne

Ages Eligible for Study
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Minimum Age: 9 Years
Maximum Age: 99 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: SB204 4%<br>SB204 4% topically once daily | Drug: SB204 4%<br>* Once daily<br>* Other names: NVN1000;|
| Placebo Comparator: Vehicle Gel<br>Vehicle Gel topically once daily | Drug: Vehicle Gel<br>* Placebo comparator<br>* Other names: Placebo;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Absolute Change From Baseline in Inflammatory Lesion Counts | The absolute change from Baseline in inflammatory lesion counts was to be assessed on the face only (forehead, right and left cheeks, chin, and nose). Inflammatory lesions included papules, pustules, nodules, and cysts. | Baseline and Week 12 | 
| Absolute Change From Baseline in Non-inflammatory Lesion Counts | The absolute change from Baseline in non-inflammatory lesion counts was to be assessed on the face only (forehead, right and left cheeks, chin, and nose). Non-inflammatory lesions included open comedones (blackheads) and closed comedones (whiteheads). | Baseline and Week 12 | 
| Proportion of Subjects With Investigator Global Assessment (IGA) Success at Week 12 | Proportion of subjects with Investigator Global Assessment (IGA) Success at Week 12 is defined as an IGA score of 0 or 1 (Clear/Almost Clear) and at least a 2 grade improvement from Baseline. The IGA scale is as follows: Grade Description 0 Clear: Clear skin with no inflammatory or non-inflammatory lesions. Almost clear: Rare non-inflammatory lesions with rare papules (papules may be resolving and hyperpigmented, though not pink-red). Mild: Some non-inflammatory lesions with no more than a few inflammatory lesions. Moderate: Up to many non-inflammatory lesions and may have some inflammatory lesions, but no more than one nodulocystic lesion. Severe: Up to many non-inflammatory and inflammatory lesions, but no more than a few nodulocystic lesions | Baseline and Week 12 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percent Change in Inflammatory Lesion Count | The percent change from baseline in inflammatory lesion count | Baseline and Week 12 | 
| Percent Change in Non-inflammatory Lesion Count | The percent change from baseline in non-inflammatory lesion count | Baseline and Week 12 | 
| Time to Reduction in Inflammatory Lesion Counts | Median time to a 35% reduction in inflammatory lesion count (Kaplan-Meier) | Week 12 | 
| Time to Improvement in IGA | Median time to a 2 or more grade improvement in IGA (Kaplan-Meier analysis). | Week 12 |