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

AndroScience Corp186 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

186

Conditions

Acne Vulgaris

Interventions

ASC-J9 creamDRUG

Topical application to the face twice daily for 12 weeks.

placeboDRUG

vehicle control applied topically twice daily for 12 weeks

Eligibility

Sex: ALLMin age: 12 Years

Medical Language ↔ Plain English

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

Locations (10)

East Bay Dermatology Medical Group

Fremont, California, United States

Therapeutics Clinical Research

San Diego, California, United States

Northwest Clinical Trial

Boise, Idaho, United States

Outcomes

Primary Outcomes

Percent Change in Inflammatory Acne Lesion Counts From 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.

Time frame: Baseline to Week 12

Secondary Outcomes

Number of Participants With Improvement in Investigator Global Assessment by at Least One Grade From 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.

Time frame: Baseline to Week 12

Data from ClinicalTrials.gov

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