Topical ASC-J9 Cream for Acne

Study Overview
=================
Brief Summary
-----------------
To evaluate the safety and efficacy of topical 0.1% and 0.025% ASC-J9 creams applied twice daily for facial acne compared to vehicle control.

Detailed Description
-----------------
Approximately 180 patients at least 12 years of age with facial acne will be randomized to twice daily topical treatment with 0.1% or 0.025% ASC-J9 cream or vehicle control for 12 weeks. Patients will return to the clinic at Weeks 2, 4, 8 and 12 and again 4 weeks after the last dose of study drug for evaluation of acne status and safety parameters.

Official Title
-----------------
Phase 2, Multi-Center, Randomized, Double-Blind, Vehicle-Controlled Clinical Study to Evaluate the Safety and Efficacy of 0.1% and 0.025% ASC-J9 Creams Applied Topically Twice Daily for 12 Weeks for the Treatment of Facial Acne Vulgaris

Conditions
-----------------
Acne

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


Participation Criteria
=================
Eligibility Criteria
-----------------
Key Inclusion Criteria: At least 12 years of age at the time of enrollment Facial acne, with: 20-60 inflammatory facial lesions (papules/pustules/nodules/cysts); 20-100 noninflammatory facial lesions (open and closed comedones); No more than 2 nodules/cysts on the face (defined as an inflammatory lesion greater than or equal to 5 mm in diameter); Investigator's Global Assessment (IGA) acne score of 3 or 4. Key Exclusion Criteria: Females who are pregnant or breast-feeding Skin diseases other than acne vulgaris Use of other topical or systemic treatments for acne Other significant medical conditions or clinically significant abnormal laboratory test results.

Ages Eligible for Study
-----------------
Minimum Age: 12 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Vehicle control cream<br> | Drug: ASC-J9<br>* Cream for twice daily topical application to the face<br>|
| Experimental: 0.025% ASC-J9 cream<br> | Drug: ASC-J9<br>* Cream for twice daily topical application to the face<br>|
| Experimental: 0.1% ASC-J9 cream<br> | Drug: ASC-J9<br>* Cream for twice daily topical application to the face<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percent Change in Inflammatory Acne Lesion Counts | Percent change from Baseline | 12 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Success on Investigator Global Assessment (IGA) at Week 12 | Overall acne rated as clear, almost clear, mild, moderate, severe, very severe. Success = Week 12 rating of clear or almost clear and at least a 2-grade improvement from baseline | 12 weeks | 
| Percent Change in Noninflammatory Acne Lesion Counts | Percent change from Baseline | 12 weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
androgen receptor degradation enhancer