Back to resultsA Phase 2 Study of ASC-J9 Cream in Acne Vulgaris
Primary Purpose
Acne Vulgaris
Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
ASC-J9 cream
placebo
Sponsored by
About this trial
This is an interventional treatment trial for Acne Vulgaris focused on measuring 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
Sites / Locations
- East Bay Dermatology Medical Group
- Therapeutics Clinical Research
- Northwest Clinical Trial
- TKL Research, Inc
- Academic Dermatology Associates
- Dermatology Associates
- DermResearch, Inc
- J&S Studies, Inc
- Dermatology Research Center, Inc
- Education and Research Foundation
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm Type
Placebo Comparator
Experimental
Experimental
Experimental
Arm Label
1
2
3
4
Arm Description
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
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
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.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00525499
Brief Title
A Phase 2 Study of ASC-J9 Cream in Acne Vulgaris
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
Study Type
Interventional
2. Study Status
Record Verification Date
November 2011
Overall Recruitment Status
Completed
Study Start Date
August 2007 (undefined)
Primary Completion Date
April 2008 (Actual)
Study Completion Date
July 2008 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
AndroScience Corp
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acne Vulgaris
Keywords
acne
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
186 (Actual)
8. Arms, Groups, and Interventions
Arm Title
1
Arm Type
Placebo Comparator
Arm Description
Vehicle control cream applied topically to the face twice daily for 12 weeks
Arm Title
2
Arm Type
Experimental
Arm Description
0.001% ASC-J9 cream applied topically to the face twice daily for 12 weeks
Arm Title
3
Arm Type
Experimental
Arm Description
0.005% ASC-J9 cream applied topically to the face twice daily for 12 weeks
Arm Title
4
Arm Type
Experimental
Arm Description
0.025% ASC-J9 cream applied topically to the face twice daily for 12 weeks
Intervention Type
Drug
Intervention Name(s)
ASC-J9 cream
Intervention Description
Topical application to the face twice daily for 12 weeks.
Intervention Type
Drug
Intervention Name(s)
placebo
Other Intervention Name(s)
Androgen receptor degradation enhancer
Intervention Description
vehicle control applied topically twice daily for 12 weeks
Primary Outcome Measure Information:
Title
Percent Change in Inflammatory Acne Lesion Counts From Baseline to Week 12
Description
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.
Time Frame
Baseline to Week 12
Secondary Outcome Measure Information:
Title
Number of Participants With Improvement in Investigator Global Assessment by at Least One Grade From Baseline to Week 12
Description
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.
Time Frame
Baseline to Week 12
10. Eligibility
Sex
All
Minimum Age & Unit of Time
12 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Charles CY Shih, PhD
Organizational Affiliation
AndroScience Corp
Official's Role
Study Chair
Facility Information:
Facility Name
East Bay Dermatology Medical Group
City
Fremont
State/Province
California
ZIP/Postal Code
94538
Country
United States
Facility Name
Therapeutics Clinical Research
City
San Diego
State/Province
California
ZIP/Postal Code
92123
Country
United States
Facility Name
Northwest Clinical Trial
City
Boise
State/Province
Idaho
ZIP/Postal Code
83704
Country
United States
Facility Name
TKL Research, Inc
City
Paramus
State/Province
New Jersey
ZIP/Postal Code
07652
Country
United States
Facility Name
Academic Dermatology Associates
City
Albuquerque
State/Province
New Mexico
ZIP/Postal Code
87106
Country
United States
Facility Name
Dermatology Associates
City
Knoxville
State/Province
Tennessee
ZIP/Postal Code
37934
Country
United States
Facility Name
DermResearch, Inc
City
Austin
State/Province
Texas
ZIP/Postal Code
78759
Country
United States
Facility Name
J&S Studies, Inc
City
Bryan
State/Province
Texas
ZIP/Postal Code
77802
Country
United States
Facility Name
Dermatology Research Center, Inc
City
Salt Lake City
State/Province
Utah
ZIP/Postal Code
84124
Country
United States
Facility Name
Education and Research Foundation
City
Lynchburg
State/Province
Virginia
ZIP/Postal Code
24501
Country
United States
12. IPD Sharing Statement
Learn more about this trial
A Phase 2 Study of ASC-J9 Cream in Acne Vulgaris
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