Topical ASC-J9 Cream for Acne

Phase 2

Completed

• Conditions: Acne
• Interventions: Drug: ASC-J9

• Registration Number: NCT01289574
• Lead Sponsor: AndroScience Corp

Brief Summary

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.

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 Timeline

• Study Start: 2011-02
• Study First Submitted: 2011-02-02
• Study First Submitted QC: 2011-02-02
• Study First Posted: 2011-02-03
• Primary Completion: 2012-07
• Study Completion: 2012-08
• Results First Submitted: 2014-06-27
• Results First Submitted QC: 2014-06-27
• Status Verified: 2014-07
• Results First Posted: 2014-07-25
• Last Update Submitted: 2014-07-29
• Last Update Posted: 2014-08-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 181

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
0.025% ASC-J9 cream	ASC-J9	-
Vehicle control cream	ASC-J9	-
0.1% ASC-J9 cream	ASC-J9	-

Primary Outcome Measures

Name	Time	Method
Percent Change in Inflammatory Acne Lesion Counts	12 weeks	Percent change from Baseline

Secondary Outcome Measures

Name	Time	Method
Success on Investigator Global Assessment (IGA) at Week 12	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	12 weeks	Percent change from Baseline

Trial Locations

Locations (7)

TKL Research, Inc; 🇺🇸 Paramus, New Jersey, United States

Chang Gung Memorial Hospital; 🇨🇳 NiaoSong District, Kaohsiung City, Taiwan

Chang Gung Memorial Hospital - Linkou Branch; 🇨🇳 Gueishan Township, Taoyuan County, Taiwan

Shih Kong Wu Ho-Su Memorial Hospital; 🇨🇳 Taipei City, Taipei, Taiwan

Wan Fang Hospital; 🇨🇳 Taipei, Taiwan

Tri-Service General Hospital; 🇨🇳 Taipei City, Taipei, Taiwan

Taipei Medical University Hospital; 🇨🇳 Taipei City, Taipei, Taiwan