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
Cream for twice daily topical application to the face
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
Percent Change in Inflammatory Acne Lesion Counts
Percent change from Baseline
Time frame: 12 weeks
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
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Taipei Medical University Hospital
Taipei City, Taipei, Taiwan
Wan Fang Hospital
Taipei, Taipei, Taiwan
Chang Gung Memorial Hospital - Linkou Branch
Gueishan Township, Taoyuan County, Taiwan