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

AndroScience

Status and phase: Completed; Phase 2

Conditions: Acne Vulgaris

Treatments: Drug: ASC-J9 cream; Drug: placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT00525499

ASC-J9-201

Details and patient eligibility

About

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

Full description

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.

Enrollment: 186 patients

Sex: All

Ages: 12+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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186 participants in 4 patient groups, including a placebo group

1

Placebo Comparator group

Description:

Vehicle control cream applied topically to the face twice daily for 12 weeks

Treatment:

Drug: placebo

2

Experimental group

Description:

0.001% ASC-J9 cream applied topically to the face twice daily for 12 weeks

Treatment:

Drug: ASC-J9 cream

3

Experimental group

Description:

0.005% ASC-J9 cream applied topically to the face twice daily for 12 weeks

Treatment:

Drug: ASC-J9 cream

4

Experimental group

Description:

0.025% ASC-J9 cream applied topically to the face twice daily for 12 weeks

Treatment:

Drug: ASC-J9 cream