Phase 2
N=186
A Phase 2 Study of ASC-J9 Cream in Acne Vulgaris
Acne Vulgaris
Bottom Line
View on ClinicalTrials.gov: NCT00525499 ↗Enrolled (actual)
186
Serious AEs
0.5%
Results posted
Apr 2011
Primary outcome: Primary: Percent Change in Inflammatory Acne Lesion Counts From Baseline to Week 12 — -37.4; -34.7; -30.7; -44.8 Percent change
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- ASC-J9 cream (Drug); placebo (Drug)
- Age
- Pediatric, Adult, Older Adult · 12+ yrs
- Sex
- All
- Sponsor
- AndroScience Corp
- Primary completion
- Apr 2008
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percent Change in Inflammatory Acne Lesion Counts From Baseline to Week 12 |
-37.4; -34.7; -30.7; -44.8 | — |
| SECONDARY Number of Participants With Improvement in Investigator Global Assessment by at Least One Grade From Baseline to Week 12 |
23; 20; 23; 28 | — |
Summary
The purpose of this study is to evaluate if topical ASC-J9 cream is effective in treating acne.
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT00525499). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.