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Completed

NCT Number: NCT00525499

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

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

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Key information

Conditions

Acne Vulgaris Acneiform Eruptions Sebaceous Gland Diseases Skin Diseases Skin and Connective Tissue Diseases

Age range

12 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

East Bay Dermatology Medical Group, Fremont, California, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

ASC-J9 cream

Drug

Topical application to the face twice daily for 12 weeks.

Placebo

Drug

vehicle control applied topically twice daily for 12 weeks

Other names: Androgen receptor degradation enhancer

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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.

    • Rare non-inflammatory lesions.
    • Some non-inflammatory lesions, no more than a few inflammatory lesions. No nodulo-cystic lesions.
    • Many non-inflammatory lesions, some inflammatory lesions, no more than one nodulo-cystic lesion.
    • Many noninflammatory and inflammatory lesions but no more than a few nodulo-cystic lesions.
    • Highly inflammatory lesions, multiple nodulo-cystic lesions.

Sponsors and collaborators

Lead sponsor

AndroScience Corp

Industry

Registry information

Official study 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

Important dates

Study start
2007
Primary completion
2008
Study completion
2008
First posted
Sep 5, 2007
Registry last updated
Nov 23, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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