A Phase 2 Study of ASC-J9 Cream in Acne Vulgaris

Study Overview
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Brief Summary
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The purpose of this study is to evaluate if topical ASC-J9 cream is effective in treating acne.

Detailed Description
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Subjects with acne were randomized to one of four treatment groups for twice daily topical dosing to the face for 12 weeks. Assessments of acne status were performed at Baseline, Weeks 2, 4, 8 and 12 and then 4 weeks after the last dose of study drug.

Official Title
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A Phase 2, Multi-Center, Randomized, Double-Blind, Vehicle-Controlled Dose-Ranging Clinical Study to Evaluate the Safety and Efficacy of ASC-J9 Cream Applied Twice Daily for 12 Weeks for the Treatment of Facial Acne Vulgaris

Conditions
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Acne Vulgaris

Intervention / Treatment
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* Drug: ASC-J9 cream
* Drug: placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: At least 12 years of age. Facial acne, with: 20 -100 inflammatory facial lesions 20 -100 noninflammatory facial lesions No more than 2 nodules/cysts on the face Exclusion Criteria: Women who are pregnant or breastfeeding Skin diseases other than acne vulgaris Use of oral retinoids within 6 months of Baseline Visit Unwilling to discontinue all other treatments for facial acne Unwilling to avoid excessive swimming/sun exposure and use of cosmetics

Ages Eligible for Study
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Minimum Age: 12 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: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: 1<br>Vehicle control cream applied topically to the face twice daily for 12 weeks | Drug: placebo<br>* vehicle control applied topically twice daily for 12 weeks<br>* Other names: Androgen receptor degradation enhancer;|
| Experimental: 2<br>0.001% ASC-J9 cream applied topically to the face twice daily for 12 weeks | Drug: ASC-J9 cream<br>* Topical application to the face twice daily for 12 weeks.<br>|
| Experimental: 3<br>0.005% ASC-J9 cream applied topically to the face twice daily for 12 weeks | Drug: ASC-J9 cream<br>* Topical application to the face twice daily for 12 weeks.<br>|
| Experimental: 4<br>0.025% ASC-J9 cream applied topically to the face twice daily for 12 weeks | Drug: ASC-J9 cream<br>* Topical application to the face twice daily for 12 weeks.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percent Change in Inflammatory Acne Lesion Counts From Baseline to Week 12 | Percent change in inflammatory lesion counts from Baseline to Week 12. It is calculated by taking the Week 12 count minus the Baseline count and then dividing by the Baseline count. Thus, a negative percent change will reflect a reduction in lesion counts. | Baseline to Week 12 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Participants With Improvement in Investigator Global Assessment by at Least One Grade From Baseline to Week 12 | The Investigator Global Assessment used a static categorical scale, with zero corresponding to no acne and higher scores reflecting more severe acne: 0 No acne lesions. Rare non-inflammatory lesions. Some non-inflammatory lesions, no more than a few inflammatory lesions. No nodulo-cystic lesions. Many non-inflammatory lesions, some inflammatory lesions, no more than one nodulo-cystic lesion. Many noninflammatory and inflammatory lesions but no more than a few nodulo-cystic lesions. Highly inflammatory lesions, multiple nodulo-cystic lesions. | Baseline to Week 12 | 

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