A Phase 2 Study of ASC-J9 Cream in Acne Vulgaris

November 16, 2011 updated by: AndroScience Corp

A Phase 2, Multi-Center, Randomized, Double-Blind, Vehicle-Controlled Dose-Ranging Clinical Study to Evaluate the Safety and Efficacy of ASC-J9 Cream Applied Twice Daily for 12 Weeks for the Treatment of Facial Acne Vulgaris

The purpose of this study is to evaluate if topical ASC-J9 cream is effective in treating acne.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Subjects with acne were randomized to one of four treatment groups for twice daily topical dosing to the face for 12 weeks. Assessments of acne status were performed at Baseline, Weeks 2, 4, 8 and 12 and then 4 weeks after the last dose of study drug.

Study Type

Interventional

Enrollment (Actual)

186

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • Fremont, California, United States, 94538
        • East Bay Dermatology Medical Group
      • San Diego, California, United States, 92123
        • Therapeutics Clinical Research
    • Idaho
      • Boise, Idaho, United States, 83704
        • Northwest Clinical Trial
    • New Jersey
      • Paramus, New Jersey, United States, 07652
        • TKL Research, Inc
    • New Mexico
      • Albuquerque, New Mexico, United States, 87106
        • Academic Dermatology Associates
    • Tennessee
      • Knoxville, Tennessee, United States, 37934
        • Dermatology Associates
    • Texas
      • Austin, Texas, United States, 78759
        • DermResearch, Inc
      • Bryan, Texas, United States, 77802
        • J&S Studies, Inc
    • Utah
      • Salt Lake City, Utah, United States, 84124
        • Dermatology Research Center, Inc
    • Virginia
      • Lynchburg, Virginia, United States, 24501
        • Education and Research Foundation

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

12 years and older (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • At least 12 years of age.

  • Facial acne, with:

    20 -100 inflammatory facial lesions 20 -100 noninflammatory facial lesions No more than 2 nodules/cysts on the face

Exclusion Criteria:

  • Women who are pregnant or breastfeeding
  • Skin diseases other than acne vulgaris
  • Use of oral retinoids within 6 months of Baseline Visit
  • Unwilling to discontinue all other treatments for facial acne
  • Unwilling to avoid excessive swimming/sun exposure and use of cosmetics

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: 1
Vehicle control cream applied topically to the face twice daily for 12 weeks
Drug: placebo
vehicle control applied topically twice daily for 12 weeks
Other Names:
  • Androgen receptor degradation enhancer
Experimental: 2
0.001% ASC-J9 cream applied topically to the face twice daily for 12 weeks
Drug: ASC-J9 cream
Topical application to the face twice daily for 12 weeks.
Experimental: 3
0.005% ASC-J9 cream applied topically to the face twice daily for 12 weeks
Drug: ASC-J9 cream
Topical application to the face twice daily for 12 weeks.
Experimental: 4
0.025% ASC-J9 cream applied topically to the face twice daily for 12 weeks
Drug: ASC-J9 cream
Topical application to the face twice daily for 12 weeks.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Percent Change in Inflammatory Acne Lesion Counts From Baseline to Week 12
Time Frame: Baseline to Week 12
Percent change in inflammatory lesion counts from Baseline to Week 12. It is calculated by taking the Week 12 count minus the Baseline count and then dividing by the Baseline count. Thus, a negative percent change will reflect a reduction in lesion counts.
Baseline to Week 12

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of Participants With Improvement in Investigator Global Assessment by at Least One Grade From Baseline to Week 12
Time Frame: Baseline to Week 12

The Investigator Global Assessment used a static categorical scale, with zero corresponding to no acne and higher scores reflecting more severe acne:

0 No acne lesions.

  1. Rare non-inflammatory lesions.
  2. Some non-inflammatory lesions, no more than a few inflammatory lesions. No nodulo-cystic lesions.
  3. Many non-inflammatory lesions, some inflammatory lesions, no more than one nodulo-cystic lesion.
  4. Many noninflammatory and inflammatory lesions but no more than a few nodulo-cystic lesions.
  5. Highly inflammatory lesions, multiple nodulo-cystic lesions.
Baseline to Week 12

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

AndroScience Corp

Investigators

  • Study Chair: Charles CY Shih, PhD, AndroScience Corp

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2007

Primary Completion (Actual)

April 1, 2008

Study Completion (Actual)

July 1, 2008

Study Registration Dates

First Submitted

August 31, 2007

First Submitted That Met QC Criteria

August 31, 2007

First Posted (Estimate)

September 5, 2007

Study Record Updates

Last Update Posted (Estimate)

November 23, 2011

Last Update Submitted That Met QC Criteria

November 16, 2011

Last Verified

November 1, 2011

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ASC-J9-201

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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