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Topical ASC-J9 Cream for Acne

This study has been completed.
Orient Europharma Co., Ltd.
Information provided by (Responsible Party):
AndroScience Corp Identifier:
First received: February 2, 2011
Last updated: July 29, 2014
Last verified: July 2014
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
Drug: ASC-J9
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Participant, Care Provider, 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 Change in Inflammatory Acne Lesion Counts [ Time Frame: 12 weeks ]
    Percent change from Baseline

Secondary Outcome Measures:
  • 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

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.

Ages Eligible for Study:   12 Years and older   (Child, Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT01289574

United States, New Jersey
TKL Research, Inc
Paramus, New Jersey, United States, 07652
Chang Gung Memorial Hospital
NiaoSong District, Kaohsiung City, Taiwan
Shih Kong Wu Ho-Su Memorial Hospital
Taipei City, Taipei, Taiwan, 11160
Tri-Service General Hospital
Taipei City, Taipei, Taiwan, 11490
Taipei Medical University Hospital
Taipei City, Taipei, Taiwan
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.
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
  More Information

Responsible Party: AndroScience Corp Identifier: NCT01289574     History of Changes
Other Study ID Numbers: ASC-J9-202
Study First Received: February 2, 2011
Results First Received: June 27, 2014
Last Updated: July 29, 2014

Keywords provided by AndroScience Corp:
androgen receptor degradation enhancer processed this record on May 25, 2017