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

August 31, 2007
November 16, 2011
August 2007
April 2008   (final data collection date for primary outcome measure)
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.
Acne lesion counts and Investigator's Global Assessment (IGA) [ Time Frame: 12 weeks ]
Complete list of historical versions of study NCT00525499 on ClinicalTrials.gov Archive Site
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.
Not Provided
Not Provided
Not Provided
 
A Phase 2 Study of ASC-J9 Cream in Acne Vulgaris
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.

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.

Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Acne Vulgaris
  • Drug: ASC-J9 cream
    Topical application 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
  • Placebo Comparator: 1
    Vehicle control cream applied topically to the face twice daily for 12 weeks
    Intervention: Drug: placebo
  • Experimental: 2
    0.001% ASC-J9 cream applied topically to the face twice daily for 12 weeks
    Intervention: Drug: ASC-J9 cream
  • Experimental: 3
    0.005% ASC-J9 cream applied topically to the face twice daily for 12 weeks
    Intervention: Drug: ASC-J9 cream
  • Experimental: 4
    0.025% ASC-J9 cream applied topically to the face twice daily for 12 weeks
    Intervention: Drug: ASC-J9 cream
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
186
July 2008
April 2008   (final data collection date for primary outcome measure)

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
Both
12 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00525499
ASC-J9-201
No
AndroScience Corp
AndroScience Corp
Not Provided
Study Chair: Charles CY Shih, PhD AndroScience Corp
AndroScience Corp
November 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP