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: August 7, 2012
Last verified: August 2012
  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:

    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
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 April 17, 2014