Title
A Phase 2 Study of ASC-J9 Cream in Acne Vulgaris
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
Phase
Phase 2Lead Sponsor
AndroScience CorpStudy Type
InterventionalStatus
Completed Results PostedIndication/Condition
Acne VulgarisIntervention/Treatment
Dimethylcurcumin ...Study Participants
186The purpose of this study is to evaluate if topical ASC-J9 cream is effective in treating acne.
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.
Topical application to the face twice daily for 12 weeks.
vehicle control applied topically twice daily for 12 weeks
Vehicle control cream applied topically to the face twice daily for 12 weeks
0.001% ASC-J9 cream applied topically to the face twice daily for 12 weeks
0.005% ASC-J9 cream applied topically to the face twice daily for 12 weeks
0.025% ASC-J9 cream applied topically to the face twice daily for 12 weeks
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
| Event Type | Organ System | Event Term | Vehicle Control | 0.001% ASC-J9 Cream | 0.005% ASC-J9 Cream | 0.025% ASC-J9 Cream |
|---|
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.
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.
