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

Acne Vulgaris Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00525499
• Other study ID #: ASC-J9-201
• Status: Completed
• Phase: Phase 2
• First received: August 31, 2007
• Last updated: November 16, 2011
• Start date: August 2007
• Est. completion date: July 2008

Study information

• Verified date: November 2011
• Source: AndroScience Corp
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 186
• Est. completion date: July 2008
• Est. primary completion date: April 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 12 Years and older

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Acne Vulgaris

Intervention

Drug:
• ASC-J9 cream
Topical application to the face twice daily for 12 weeks.
• placebo
vehicle control applied topically twice daily for 12 weeks

Locations

Country	Name	City	State
United States	Academic Dermatology Associates	Albuquerque	New Mexico
United States	DermResearch, Inc	Austin	Texas
United States	Northwest Clinical Trial	Boise	Idaho
United States	J&S Studies, Inc	Bryan	Texas
United States	East Bay Dermatology Medical Group	Fremont	California
United States	Dermatology Associates	Knoxville	Tennessee
United States	Education and Research Foundation	Lynchburg	Virginia
United States	TKL Research, Inc	Paramus	New Jersey
United States	Dermatology Research Center, Inc	Salt Lake City	Utah
United States	Therapeutics Clinical Research	San Diego	California

Sponsors (1)

Lead Sponsor	Collaborator
AndroScience Corp

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	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	No