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

Phase 2

Completed

• Conditions: Acne Vulgaris
• Interventions: Drug: ASC-J9 cream; Drug: placebo

• Registration Number: NCT00525499
• Lead Sponsor: AndroScience Corp

Brief Summary

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

Detailed Description

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.

Study Timeline

• Study Start: 2007-08
• Study First Submitted: 2007-08-31
• Study First Submitted QC: 2007-08-31
• Study First Posted: 2007-09-05
• Primary Completion: 2008-04
• Study Completion: 2008-07
• Results First Submitted: 2011-01-31
• Results First Submitted QC: 2011-03-15
• Results First Posted: 2011-04-18
• Status Verified: 2011-11
• Last Update Submitted: 2011-11-16
• Last Update Posted: 2011-11-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 186

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
2	ASC-J9 cream	0.001% ASC-J9 cream applied topically to the face twice daily for 12 weeks
4	ASC-J9 cream	0.025% ASC-J9 cream applied topically to the face twice daily for 12 weeks
1	placebo	Vehicle control cream applied topically to the face twice daily for 12 weeks
3	ASC-J9 cream	0.005% ASC-J9 cream applied topically to the face twice daily for 12 weeks

Primary Outcome Measures

Name	Time	Method
Percent Change in Inflammatory Acne Lesion Counts From Baseline to Week 12	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.

Secondary Outcome Measures

Name	Time	Method
Number of Participants With Improvement in Investigator Global Assessment by at Least One Grade From Baseline to Week 12	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.; 1. Rare non-inflammatory lesions.; 2. Some non-inflammatory lesions, no more than a few inflammatory lesions. No nodulo-cystic lesions.; 3. Many non-inflammatory lesions, some inflammatory lesions, no more than one nodulo-cystic lesion.; 4. Many noninflammatory and inflammatory lesions but no more than a few nodulo-cystic lesions.; 5. Highly inflammatory lesions, multiple nodulo-cystic lesions.

Trial Locations

Locations (10)

Therapeutics Clinical Research; 🇺🇸 San Diego, California, United States

Northwest Clinical Trial; 🇺🇸 Boise, Idaho, United States

TKL Research, Inc; 🇺🇸 Paramus, New Jersey, United States

Dermatology Associates; 🇺🇸 Knoxville, Tennessee, United States

Academic Dermatology Associates; 🇺🇸 Albuquerque, New Mexico, United States

Education and Research Foundation; 🇺🇸 Lynchburg, Virginia, United States

J&S Studies, Inc; 🇺🇸 Bryan, Texas, United States

DermResearch, Inc; 🇺🇸 Austin, Texas, United States

East Bay Dermatology Medical Group; 🇺🇸 Fremont, California, United States

Dermatology Research Center, Inc; 🇺🇸 Salt Lake City, Utah, United States