Topical ASC-J9 Cream for Acne

AndroScience

Status and phase: Completed; Phase 2

Conditions: Acne

Treatments: Drug: ASC-J9

Study type: Interventional

Funder types: Industry

Identifiers

NCT01289574

ASC-J9-202

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 181 patients

Sex: All

Ages: 12+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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181 participants in 3 patient groups, including a placebo group

Vehicle control cream

Placebo Comparator group

Treatment:

Drug: ASC-J9

0.025% ASC-J9 cream

Experimental group

Treatment:

Drug: ASC-J9

0.1% ASC-J9 cream

Experimental group

Treatment:

Drug: ASC-J9