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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
AndroScience Corp
ClinicalTrials.gov Identifier:
NCT00525499
First received: August 31, 2007
Last updated: November 16, 2011
Last verified: November 2011
  Purpose

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


Condition Intervention Phase
Acne Vulgaris
Drug: ASC-J9 cream
Drug: placebo
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: 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

Resource links provided by NLM:


Further study details as provided by AndroScience Corp:

Primary Outcome Measures:
  • Percent Change in Inflammatory Acne Lesion Counts From Baseline to Week 12 [ Time Frame: Baseline to Week 12 ] [ Designated as safety issue: No ]
    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.


Secondary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

    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.


Enrollment: 186
Study Start Date: August 2007
Study Completion Date: July 2008
Primary Completion Date: April 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 Name: 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.

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.

  Eligibility

Ages Eligible for Study:   12 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  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: NCT00525499

Locations
United States, California
East Bay Dermatology Medical Group
Fremont, California, United States, 94538
Therapeutics Clinical Research
San Diego, California, United States, 92123
United States, Idaho
Northwest Clinical Trial
Boise, Idaho, United States, 83704
United States, New Jersey
TKL Research, Inc
Paramus, New Jersey, United States, 07652
United States, New Mexico
Academic Dermatology Associates
Albuquerque, New Mexico, United States, 87106
United States, Tennessee
Dermatology Associates
Knoxville, Tennessee, United States, 37934
United States, Texas
DermResearch, Inc
Austin, Texas, United States, 78759
J&S Studies, Inc
Bryan, Texas, United States, 77802
United States, Utah
Dermatology Research Center, Inc
Salt Lake City, Utah, United States, 84124
United States, Virginia
Education and Research Foundation
Lynchburg, Virginia, United States, 24501
Sponsors and Collaborators
AndroScience Corp
Investigators
Study Chair: Charles CY Shih, PhD AndroScience Corp
  More Information

No publications provided

Responsible Party: AndroScience Corp
ClinicalTrials.gov Identifier: NCT00525499     History of Changes
Other Study ID Numbers: ASC-J9-201
Study First Received: August 31, 2007
Results First Received: January 31, 2011
Last Updated: November 16, 2011
Health Authority: United States: Food and Drug Administration

Keywords provided by AndroScience Corp:
acne

Additional relevant MeSH terms:
Acne Vulgaris
Acneiform Eruptions
Skin Diseases
Facial Dermatoses
Sebaceous Gland Diseases

ClinicalTrials.gov processed this record on August 27, 2014