Phase 2 N=181 Randomized Quadruple-blind Treatment

Topical ASC-J9 Cream for Acne

Acne

Bottom Line

View on ClinicalTrials.gov: NCT01289574 ↗

Enrolled (actual)

181

Serious AEs

0.0%

Results posted

Jul 2014

Primary outcome: Primary: Percent Change in Inflammatory Acne Lesion Counts — -28.6; -44.3; -44.4 Percentage change from baseline — p=0.1919

Study Design & Population

Study type: Interventional
Phase: Phase 2
Interventions: ASC-J9 (Drug)
Age: Pediatric, Adult, Older Adult · 12+ yrs
Sex: All
Sponsor: AndroScience Corp
Primary completion: Jul 2012

Outcome Measures

Outcome	Result	p-value
PRIMARY Percent Change in Inflammatory Acne Lesion Counts	-28.6; -44.3; -44.4	0.1919
SECONDARY Success on Investigator Global Assessment (IGA) at Week 12	6.9; 21.7; 17.5	0.0610
SECONDARY Percent Change in Noninflammatory Acne Lesion Counts	-18.5; -35.5; -36.3	0.0857

Summary

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.

Eligibility Criteria

Key Inclusion Criteria

At least 12 years of age at the time of enrollment
Facial acne, with:
20-60 inflammatory facial lesions (papules/pustules/nodules/cysts);
20-100 noninflammatory facial lesions (open and closed comedones);
No more than 2 nodules/cysts on the face (defined as an inflammatory lesion greater than or equal to 5 mm in diameter);
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.

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT01289574). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.