Topical ASC-J9 Cream for Acne

This study has been completed.
Sponsor:
Collaborator:
Orient Europharma Co., Ltd.
Information provided by (Responsible Party):
AndroScience Corp
ClinicalTrials.gov Identifier:
NCT01289574
First received: February 2, 2011
Last updated: July 29, 2014
Last verified: July 2014
  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 Change in Inflammatory Acne Lesion Counts [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
    Percent change from Baseline


Secondary Outcome Measures:
  • Success on Investigator Global Assessment (IGA) at Week 12 [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]

    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 ] [ Designated as safety issue: No ]
    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.

  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:

    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 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
Results First Received: June 27, 2014
Last Updated: July 29, 2014
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 August 20, 2014