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Topical ASC-J9 Cream for Acne

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ClinicalTrials.gov Identifier: NCT01289574
Recruitment Status : Completed
First Posted : February 3, 2011
Results First Posted : July 25, 2014
Last Update Posted : August 1, 2014
Sponsor:
Collaborator:
Orient Europharma Co., Ltd.
Information provided by (Responsible Party):
AndroScience Corp

February 2, 2011
February 3, 2011
June 27, 2014
July 25, 2014
August 1, 2014
February 2011
July 2012   (Final data collection date for primary outcome measure)
Percent Change in Inflammatory Acne Lesion Counts [ Time Frame: 12 weeks ]
Percent change from Baseline
Percent Reduction in Inflammatory Acne Lesion Counts [ Time Frame: 12 weeks ]
Percent reduction from Baseline
Complete list of historical versions of study NCT01289574 on ClinicalTrials.gov Archive Site
  • Success on Investigator Global Assessment (IGA) at Week 12 [ Time Frame: 12 weeks ]
    Overall acne rated as clear, almost clear, mild, moderate, severe, very severe. Success = Week 12 rating of clear or almost clear and at least a 2-grade improvement from baseline
  • Percent Change in Noninflammatory Acne Lesion Counts [ Time Frame: 12 weeks ]
    Percent change from Baseline
  • Investigator Global Assessment (IGA) [ Time Frame: 12 weeks ]
    Investigators overall assessment of facial acne (score 0-5)
  • Percent Reduction in Noninflammatory Acne Lesion Counts [ Time Frame: 12 weeks ]
    Percent reduction from Baseline
Not Provided
Not Provided
 
Topical ASC-J9 Cream for Acne
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
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.
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.
Interventional
Phase 2
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Acne
Drug: ASC-J9
Cream for twice daily topical application to the face
  • Placebo Comparator: Vehicle control cream
    Intervention: Drug: ASC-J9
  • Experimental: 0.025% ASC-J9 cream
    Intervention: Drug: ASC-J9
  • Experimental: 0.1% ASC-J9 cream
    Intervention: Drug: ASC-J9
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
181
180
August 2012
July 2012   (Final data collection date for primary outcome measure)

Key Inclusion Criteria:

  • At least 12 years of age at the time of enrollment
  • 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.

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.
Sexes Eligible for Study: All
12 Years and older   (Child, Adult, Older Adult)
No
Contact information is only displayed when the study is recruiting subjects
Taiwan,   United States
 
 
NCT01289574
ASC-J9-202
No
Not Provided
Not Provided
AndroScience Corp
AndroScience Corp
Orient Europharma Co., Ltd.
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
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
AndroScience Corp
July 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP