P2 Multi-center Study of SB204 Gel in the Treatment of Acne Vulgaris

Study Overview
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Brief Summary
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This is a randomized, multi-center, double-blinded study in subjects with moderate to severe acne vulgaris. Subjects eligible to enroll will be treated once or twice daily with 2 concentrations of a topical drug in development or a vehicle. Subjects will be treated for up to 12 weeks.

Detailed Description
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A randomized, multi-center, double-blinded study in subjects with moderate to severe acne vulgaris. Subjects eligible to enroll will be treated once or twice daily with 2 concentrations of a topical drug in development or a vehicle. Subjects will be treated for up to 12 weeks.

Official Title
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A Phase 2, Multi-Center, Randomized, Evaluator-Blinded, Vehicle-Controlled Study Comparing the Efficacy, Tolerability, and Safety of SB204 Gel and Vehicle Gel Once or Twice Daily in the Treatment of Acne Vulgaris

Conditions
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Acne Vulgaris

Intervention / Treatment
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* Drug: SB204 2%
* Drug: SB204 4%
* Drug: Vehicle Gel


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Moderate to severe acne 25-70 non-inflammatory lesions at Baseline 20-40 inflammatory lesions at Baseline Exclusion Criteria: Subjects with known allergy to any component of the test material or vehicle Women who are pregnant or nursing

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: SB204 2% Twice daily<br>Twice daily SB204 2% | Drug: SB204 2%<br>* Applied topically twice daily<br>* Other names: NVN1000;|
| Experimental: SB204 4% daily<br>Once daily SB204 4% | Drug: SB204 4%<br>* Applied topically daily<br>* Other names: NVN1000;|
| Placebo Comparator: Vehicle Gel Daily<br>Vehicle Gel Daily | Drug: Vehicle Gel<br>* Applied topically twice and once daily<br>* Other names: Placeco;|
| Placebo Comparator: Vehicle Gel Twice Daily<br>Twice daily Vehicle Gel | Drug: Vehicle Gel<br>* Applied topically twice and once daily<br>* Other names: Placeco;|
| Experimental: SB204 4% Twice Daily<br>Twice daily SB204 4% | Drug: SB204 4%<br>* Applied topically daily<br>* Other names: NVN1000;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Absolute Change in Inflammatory Lesion Counts | Change in inflammatory lesion count from Baseline to Week 12 | Baseline and Week 12 | 
| Absolute Change in Non-inflammatory Lesion Counts | Absolute Change in non-inflammatory lesion count from Baseline to Week 12 | Baseline and Week 12 | 
| Proportion of Success According to the Dichotomized Investigator Global Assessment [IGA] at End of Treatment | Proportion of subjects at end of treatment achieving IGA of 'clear' or 'almost clear' and a change of at least 2 in the IGA from baseline. The IGA was a static assessment. The assessment was made with the evaluator approximately 3 feet away from the subject; the IGA assessment was to be done prior to the lesion counts. A lower grade is considered to be a better outcome. Grade 0 = clear (clear skin with no inflammatory or non-inflammatory lesions) Grade 1 = almost clear (few non-inflammatory lesions with no more than rare papules (papules may be resolving and hyperpigmented, though not pink-red) Grade 2 = mild (some non-inflammatory lesions with no more than a few inflammatory lesions) Grade 3 = moderate (up to many non-inflammatory lesions and may have some inflammatory lesions, but no more than 1 nodular lesion) Grade 4= severe (up to many non-inflammatory and inflammatory lesions, including nodular lesions) | Baseline and Week 12 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percent Change in Inflammatory Lesion Count From Baseline to Week 12 | The percent change in inflammatory lesion count from Baseline to Week 12 | Baseline and Week 12 | 
| Percent Change in Non-inflammatory Lesion Count From Baseline to Week 12 | The percent change in non-inflammatory lesion count from Baseline to Week 12 | Baseline and Week 12 | 
| Median Time to Improvement | Median time to a 35% improvement in inflammatory lesion counts (Kaplan-Meier estimate). The full range values presented below are estimates made from the Kaplan-Meier figure. | Baseline through Week 12 | 

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