The purpose of this study was to demonstrate that daily use of topical trifarotene (CD5789) 50 microgram per gram (mcg/g) cream when used in association with oral antibiotic is safe and effective for the treatment of severe AV.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
202
Trifarotene 50 mcg/g cream applied topically once daily on face for 12 weeks.
Doxycycline hyclate delayed release 120 mg tablets was administered orally for 12 weeks.
Trifarotene 50 mcg/g vehicle cream was applied topically once daily on face for 12 weeks.
Absolute Change From Baseline in Facial Total Lesion Counts to Week 12
Total lesion counts corresponded to the sum of inflammatory and non-inflammatory lesions, and papules. The investigator (or subinvestigator) counted all inflammatory lesions (papules, pustules, and nodular lesions) and non-inflammatory lesions (open and closed comedos; diagnosis based on palpation) on the face.
Time frame: From Baseline to Week 12
Absolute Change From Baseline in Facial Inflammatory Lesions (IL) Counts to Week 12
All inflammatory lesions (papules, pustules, and nodular lesions) were counted by investigator/subinvestigator.
Time frame: From Baseline to Week 12
Absolute Change From Baseline in Facial Non Inflammatory Lesions (NIL) Counts to Week 12
Non-inflammatory lesions (open and closed comedo) were counted by investigator/subinvestigator.
Time frame: From Baseline to Week 12
Percentage of Participants Who Achieved an IGA Score of 1 (Almost Clear) or 0 (Clear) and At Least a 2-Grade Improvement From Baseline to Week 12
IGA was an assessment scale used to evaluate facial acne severity. IGA was recorded from components collected on the case report form (CRF) using a 5-point scale where (0 = clear; 1 = almost clear; 2 = mild; 3 = moderate; 4 = severe) based on inflammation, pustules and papulation/infiltration. Success Rate was defined as the percentage of participants who achieved an IGA score of 1 (Almost Clear) or 0 (Clear) and at least a 2-grade improvement from Baseline to Week 12.
Time frame: From Baseline to Week 12
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Doxycycline hyclate delayed release 120 mg placebo tablets was administered orally for 12 weeks.
Galderma Investigational Site
Fort Smith, Arkansas, United States
Galderma Investigational Site
Hot Springs, Arkansas, United States
Galderma Investigational Site
Rogers, Arkansas, United States
Galderma Investigational Site
Newport Beach, California, United States
Galderma Investigational Site
Aventura, Florida, United States
Galderma Investigational Site
Boca Raton, Florida, United States
Galderma Investigational Site
Miramar, Florida, United States
Galderma Investigational Site
Newnan, Georgia, United States
Galderma Investigational Site
Evansville, Indiana, United States
Galderma Investigational Site
New Albany, Indiana, United States
...and 16 more locations