Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2
181 participants
INTERVENTIONAL
2011-02-28
2012-08-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Vehicle control cream
ASC-J9
Cream for twice daily topical application to the face
0.025% ASC-J9 cream
ASC-J9
Cream for twice daily topical application to the face
0.1% ASC-J9 cream
ASC-J9
Cream for twice daily topical application to the face
Interventions
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ASC-J9
Cream for twice daily topical application to the face
Eligibility Criteria
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Inclusion Criteria
* Facial acne, with:
1. 20-60 inflammatory facial lesions (papules/pustules/nodules/cysts);
2. 20-100 noninflammatory facial lesions (open and closed comedones);
3. No more than 2 nodules/cysts on the face (defined as an inflammatory lesion greater than or equal to 5 mm in diameter);
4. Investigator's Global Assessment (IGA) acne score of 3 or 4.
Exclusion Criteria
* 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.
12 Years
ALL
No
Sponsors
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Orient Europharma Co., Ltd.
INDUSTRY
AndroScience Corp
INDUSTRY
Responsible Party
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Principal Investigators
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Jonathan S Dosik, MD
Role: PRINCIPAL_INVESTIGATOR
TKL Research
Chieh-Chen Huang, MD
Role: PRINCIPAL_INVESTIGATOR
Shih Kong Wu Ho-Su Memorial Hospital
Chih-Hsun Yang, MD
Role: PRINCIPAL_INVESTIGATOR
Chang Gung Memorial Hospital
Ting-Jui Chen, MD
Role: PRINCIPAL_INVESTIGATOR
Wan Fang Hospital
Wei-Ming Wang, MD PhD
Role: PRINCIPAL_INVESTIGATOR
Tri-Service General Hospital
Kuo-Hsien Wang, MD
Role: PRINCIPAL_INVESTIGATOR
Taipei Medical University Hospital
Ji-Chen Ho, MD
Role: PRINCIPAL_INVESTIGATOR
Chang Gung Memorial Hospital Kaohsiung Branch
Locations
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TKL Research, Inc
Paramus, New Jersey, United States
Chang Gung Memorial Hospital
NiaoSong District, Kaohsiung City, Taiwan
Shih Kong Wu Ho-Su Memorial Hospital
Taipei City, Taipei, Taiwan
Tri-Service General Hospital
Taipei City, Taipei, Taiwan
Taipei Medical University Hospital
Taipei City, Taipei, Taiwan
Wan Fang Hospital
Taipei, Taipei, Taiwan
Chang Gung Memorial Hospital - Linkou Branch
Gueishan Township, Taoyuan County, Taiwan
Countries
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Other Identifiers
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ASC-J9-202
Identifier Type: -
Identifier Source: org_study_id
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