Topical ASC-J9 Cream for Acne
This study has been completed.
Sponsor:
AndroScience Corp
Collaborator:
Orient Europharma Co., Ltd.
Information provided by (Responsible Party):
AndroScience Corp
ClinicalTrials.gov Identifier:
NCT01289574
First received: February 2, 2011
Last updated: August 7, 2012
Last verified: August 2012
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Purpose
To evaluate the safety and efficacy of topical 0.1% and 0.025% ASC-J9 creams applied twice daily for facial acne compared to vehicle control.
| Condition | Intervention | Phase |
|---|---|---|
|
Acne |
Drug: ASC-J9 |
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: | Phase 2, Multi-Center, Randomized, Double-Blind, Vehicle-Controlled Clinical Study to Evaluate the Safety and Efficacy of 0.1% and 0.025% ASC-J9 Creams Applied Topically 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 reduction in inflammatory acne lesion counts [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]Percent reduction from Baseline
Secondary Outcome Measures:
- Investigator Global Assessment (IGA) [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]Investigators overall assessment of facial acne (score 0-5)
- Percent reduction in noninflammatory acne lesion counts [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]Percent reduction from Baseline
| Enrollment: | 181 |
| Study Start Date: | February 2011 |
| Study Completion Date: | August 2012 |
| Primary Completion Date: | July 2012 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Placebo Comparator: Vehicle control cream |
Drug: ASC-J9
Cream for twice daily topical application to the face
|
| Experimental: 0.025% ASC-J9 cream |
Drug: ASC-J9
Cream for twice daily topical application to the face
|
| Experimental: 0.1% ASC-J9 cream |
Drug: ASC-J9
Cream for twice daily topical application to the face
|
Detailed Description:
Approximately 180 patients at least 12 years of age with facial acne will be randomized to twice daily topical treatment with 0.1% or 0.025% ASC-J9 cream or vehicle control for 12 weeks. Patients will return to the clinic at Weeks 2, 4, 8 and 12 and again 4 weeks after the last dose of study drug for evaluation of acne status and safety parameters.
Eligibility| Ages Eligible for Study: | 12 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Key Inclusion Criteria:
- At least 12 years of age at the time of enrollment
Facial acne, with:
- 20-60 inflammatory facial lesions (papules/pustules/nodules/cysts);
- 20-100 noninflammatory facial lesions (open and closed comedones);
- No more than 2 nodules/cysts on the face (defined as an inflammatory lesion greater than or equal to 5 mm in diameter);
- Investigator's Global Assessment (IGA) acne score of 3 or 4.
Key Exclusion Criteria:
- Females who are pregnant or breast-feeding
- Skin diseases other than acne vulgaris
- Use of other topical or systemic treatments for acne
- Other significant medical conditions or clinically significant abnormal laboratory test results.
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01289574
Locations
| United States, New Jersey | |
| TKL Research, Inc | |
| Paramus, New Jersey, United States, 07652 | |
| Taiwan | |
| Chang Gung Memorial Hospital | |
| NiaoSong District, Kaohsiung City, Taiwan | |
| Shih Kong Wu Ho-Su Memorial Hospital | |
| Taipei City, Taipei, Taiwan, 11160 | |
| Taipei Medical University Hospital | |
| Taipei City, Taipei, Taiwan | |
| Tri-Service General Hospital | |
| Taipei City, Taipei, Taiwan, 11490 | |
| Chang Gung Memorial Hospital - Linkou Branch | |
| Gueishan Township, Taoyuan County, Taiwan, 33305 | |
| Wan Fang Hospital | |
| Taipei, Taiwan, 11696 | |
Sponsors and Collaborators
AndroScience Corp
Orient Europharma Co., Ltd.
Investigators
| Principal Investigator: | Jonathan S Dosik, MD | TKL Research |
| Principal Investigator: | Chieh-Chen Huang, MD | Shih Kong Wu Ho-Su Memorial Hospital |
| Principal Investigator: | Chih-Hsun Yang, MD | Chang Gung Memorial Hospital - LinKou Branch |
| Principal Investigator: | Ting-Jui Chen, MD | Wan Fang Hospital |
| Principal Investigator: | Wei-Ming Wang, MD PhD | Tri-Service General Hospital |
| Principal Investigator: | Kuo-Hsien Wang, MD | Taipei Medical University Hospital |
| Principal Investigator: | Ji-Chen Ho, MD | Chang Gung Memorial Hospital Kaohsiung Branch |
More Information
No publications provided
| Responsible Party: | AndroScience Corp |
| ClinicalTrials.gov Identifier: | NCT01289574 History of Changes |
| Other Study ID Numbers: | ASC-J9-202 |
| Study First Received: | February 2, 2011 |
| Last Updated: | August 7, 2012 |
| Health Authority: | United States: Food and Drug Administration |
Keywords provided by AndroScience Corp:
|
androgen receptor degradation enhancer |
Additional relevant MeSH terms:
|
Acne Vulgaris Acneiform Eruptions Skin Diseases Facial Dermatoses Sebaceous Gland Diseases |
ClinicalTrials.gov processed this record on May 19, 2013