A Phase 2 Study of ASC-J9 Cream in Acne Vulgaris
This study has been completed.
Sponsor:
AndroScience Corp
Information provided by (Responsible Party):
AndroScience Corp
ClinicalTrials.gov Identifier:
NCT00525499
First received: August 31, 2007
Last updated: November 16, 2011
Last verified: November 2011
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Purpose
The purpose of this study is to evaluate if topical ASC-J9 cream is effective in treating acne.
| Condition | Intervention | Phase |
|---|---|---|
|
Acne Vulgaris |
Drug: ASC-J9 cream Drug: placebo |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Treatment |
| 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 |
Resource links provided by NLM:
Further study details as provided by AndroScience Corp:
Primary Outcome Measures:
- Percent Change in Inflammatory Acne Lesion Counts From Baseline to Week 12 [ Time Frame: Baseline to Week 12 ] [ Designated as safety issue: No ]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 [ Time Frame: Baseline to Week 12 ] [ Designated as safety issue: No ]
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.
| Enrollment: | 186 |
| Study Start Date: | August 2007 |
| Study Completion Date: | July 2008 |
| Primary Completion Date: | April 2008 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Placebo Comparator: 1
Vehicle control cream applied topically to the face twice daily for 12 weeks
|
Drug: placebo
vehicle control applied topically twice daily for 12 weeks
Other Name: Androgen receptor degradation enhancer
|
|
Experimental: 2
0.001% ASC-J9 cream applied topically to the face twice daily for 12 weeks
|
Drug: ASC-J9 cream
Topical application to the face twice daily for 12 weeks.
|
|
Experimental: 3
0.005% ASC-J9 cream applied topically to the face twice daily for 12 weeks
|
Drug: ASC-J9 cream
Topical application to the face twice daily for 12 weeks.
|
|
Experimental: 4
0.025% ASC-J9 cream applied topically to the face twice daily for 12 weeks
|
Drug: ASC-J9 cream
Topical application to the face twice daily for 12 weeks.
|
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.
Eligibility| Ages Eligible for Study: | 12 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00525499
Locations
| United States, California | |
| East Bay Dermatology Medical Group | |
| Fremont, California, United States, 94538 | |
| Therapeutics Clinical Research | |
| San Diego, California, United States, 92123 | |
| United States, Idaho | |
| Northwest Clinical Trial | |
| Boise, Idaho, United States, 83704 | |
| United States, New Jersey | |
| TKL Research, Inc | |
| Paramus, New Jersey, United States, 07652 | |
| United States, New Mexico | |
| Academic Dermatology Associates | |
| Albuquerque, New Mexico, United States, 87106 | |
| United States, Tennessee | |
| Dermatology Associates | |
| Knoxville, Tennessee, United States, 37934 | |
| United States, Texas | |
| DermResearch, Inc | |
| Austin, Texas, United States, 78759 | |
| J&S Studies, Inc | |
| Bryan, Texas, United States, 77802 | |
| United States, Utah | |
| Dermatology Research Center, Inc | |
| Salt Lake City, Utah, United States, 84124 | |
| United States, Virginia | |
| Education and Research Foundation | |
| Lynchburg, Virginia, United States, 24501 | |
Sponsors and Collaborators
AndroScience Corp
Investigators
| Study Chair: | Charles CY Shih, PhD | AndroScience Corp |
More Information
No publications provided
| Responsible Party: | AndroScience Corp |
| ClinicalTrials.gov Identifier: | NCT00525499 History of Changes |
| Other Study ID Numbers: | ASC-J9-201 |
| Study First Received: | August 31, 2007 |
| Results First Received: | January 31, 2011 |
| Last Updated: | November 16, 2011 |
| Health Authority: | United States: Food and Drug Administration |
Keywords provided by AndroScience Corp:
|
acne |
Additional relevant MeSH terms:
|
Acne Vulgaris Acneiform Eruptions Skin Diseases Facial Dermatoses Sebaceous Gland Diseases |
ClinicalTrials.gov processed this record on May 22, 2013