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.

Study Overview

• Status: Completed
• Conditions: Acne
• Intervention / Treatment: Drug: ASC-J9

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.

• Study Type: Interventional
• Enrollment (Actual): 181
• Phase: Phase 2

Contacts and Locations

Study Locations

• Taiwan
  • Taipei, Taiwan, 11696
    • Wan Fang Hospital
  • Kaohsiung City
    • NiaoSong District, Kaohsiung City, Taiwan
      • Chang Gung memorial hospital
  • Taipei
    • Taipei City, Taipei, Taiwan, 11160
      • Shih Kong Wu Ho-Su Memorial Hospital
    • Taipei City, Taipei, Taiwan, 11490
      • Tri-Service General Hospital
    • Taipei City, Taipei, Taiwan
      • Taipei Medical University Hospital
  • Taoyuan County
    • Gueishan Township, Taoyuan County, Taiwan, 33305
      • Chang Gung Memorial Hospital - Linkou Branch
• United States
  • New Jersey
    • Paramus, New Jersey, United States, 07652
      • TKL Research, Inc

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 12 years and older (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percent Change in Inflammatory Acne Lesion Counts	Percent change from Baseline	12 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Success on Investigator Global Assessment (IGA) at Week 12	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	12 weeks
Percent Change in Noninflammatory Acne Lesion Counts	Percent change from Baseline	12 weeks

Collaborators and Investigators

• Sponsor: AndroScience Corp
• Collaborators: 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; 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

Study record dates

Study Major Dates

• Study Start: February 1, 2011
• Primary Completion (Actual): July 1, 2012
• Study Completion (Actual): August 1, 2012

Study Registration Dates

• First Submitted: February 2, 2011
• First Submitted That Met QC Criteria: February 2, 2011
• First Posted (Estimate): February 3, 2011

Study Record Updates

• Last Update Posted (Estimate): August 1, 2014
• Last Update Submitted That Met QC Criteria: July 29, 2014
• Last Verified: July 1, 2014

More Information

Terms related to this study

• Keywords: androgen receptor degradation enhancer
• Additional Relevant MeSH Terms: Skin Diseases; Acneiform Eruptions; Sebaceous Gland Diseases; Acne Vulgaris
• Other Study ID Numbers: ASC-J9-202