Topical ASC-J9 Cream for Acne

AndroScience Corp181 enrolled

Overview

To evaluate the safety and efficacy of topical 0.1% and 0.025% ASC-J9 creams applied twice daily for facial acne compared to vehicle control.

Approximately 180 patients at least 12 years of age with facial acne will be randomized to twice daily topical treatment with 0.1% or 0.025% ASC-J9 cream or vehicle control for 12 weeks. Patients will return to the clinic at Weeks 2, 4, 8 and 12 and again 4 weeks after the last dose of study drug for evaluation of acne status and safety parameters.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

181

Conditions

Acne

Interventions

ASC-J9DRUG

Cream for twice daily topical application to the face

Eligibility

Sex: ALLMin age: 12 Years

Medical Language ↔ Plain English

Key Inclusion Criteria: * At least 12 years of age at the time of enrollment * Facial acne, with: 1. 20-60 inflammatory facial lesions (papules/pustules/nodules/cysts); 2. 20-100 noninflammatory facial lesions (open and closed comedones); 3. No more than 2 nodules/cysts on the face (defined as an inflammatory lesion greater than or equal to 5 mm in diameter); 4. Investigator's Global Assessment (IGA) acne score of 3 or 4. Key Exclusion Criteria: * Females who are pregnant or breast-feeding * Skin diseases other than acne vulgaris * Use of other topical or systemic treatments for acne * Other significant medical conditions or clinically significant abnormal laboratory test results.

Locations (7)

TKL Research, Inc

Paramus, New Jersey, United States

Chang Gung Memorial Hospital

NiaoSong District, Kaohsiung City, Taiwan

Shih Kong Wu Ho-Su Memorial Hospital

Taipei City, Taipei, Taiwan

Tri-Service General Hospital

Taipei City, Taipei, Taiwan

Outcomes

Primary Outcomes

Percent Change in Inflammatory Acne Lesion Counts

Percent change from Baseline

Time frame: 12 weeks

Secondary Outcomes

Success on Investigator Global Assessment (IGA) at Week 12

Overall acne rated as clear, almost clear, mild, moderate, severe, very severe. Success = Week 12 rating of clear or almost clear and at least a 2-grade improvement from baseline

Time frame: 12 weeks

Percent Change in Noninflammatory Acne Lesion Counts

Percent change from Baseline

Time frame: 12 weeks

Data from ClinicalTrials.gov

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