The purpose of this study is to evaluate the efficacy and safety of Trifarotene 50 microgram per gram (mcg/g) cream compared to its vehicle cream in the treatment of moderate acne vulgaris with risk of acne-induced post inflammatory hyperpigmentation (PIH) after 24 weeks of treatment in facial acne participants
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
123
Participants will apply a thin a layer of trifarotene (CD5789) 50 mcg/g cream on the face once daily, in the evening for 24 weeks
Participants will apply a thin a layer of trifarotene vehicle cream on the face once daily, in the evening for 24 weeks
Absolute Change From Baseline in Post-Inflammatory Hyperpigmentation (PIH) Overall Disease Severity (ODS) Scores at Week 24
The PIH ODS Score is based on a 9-point scale: Grade 0 Normal; Grade 1 Present, but \<mild; Grade 2 Mild (slightly noticeable); Grade 3 Between mild and moderate; Grade 4 Moderate; Grade 5 Between moderate and marked; Grade 6 Marked (distinctive); Grade 7 Between marked and severe; Grade 8 Severe (very distinctive). A negative change indicates a reduction from in PIH disease severity score from baseline.
Time frame: Baseline and Week 24
Percent Change From Baseline in PIH ODS Scores at Week 24
The PIH ODS Score is based on a 9-point scale: Grade 0 Normal; Grade 1 Present, but \<mild; Grade 2 Mild (slightly noticeable); Grade 3 Between mild and moderate; Grade 4 Moderate; Grade 5 Between moderate and marked; Grade 6 Marked (distinctive); Grade 7 Between marked and severe; Grade 8 Severe (very distinctive). A negative change indicates a reduction from in PIH disease severity score from baseline.
Time frame: Baseline and Week 24
Absolute Change From Baseline in PIH ODS Scores at Weeks 12, 16 and 20
The PIH ODS Score is based on a 9-point scale: Grade 0 Normal; Grade 1 Present, but \<mild; Grade 2 Mild (slightly noticeable); Grade 3 Between mild and moderate; Grade 4 Moderate; Grade 5 Between moderate and marked; Grade 6 Marked (distinctive); Grade 7 Between marked and severe; Grade 8 Severe (very distinctive). A negative change indicates a reduction from in PIH disease severity score from baseline.
Time frame: Baseline, at Week 12, Week 16 and Week 20
Percent Change From Baseline in PIH Overall Disease Severity Scores at Weeks 12, 16 and 20
The PIH ODS Score is based on a 9-point scale: Grade 0 Normal; Grade 1 Present, but \<mild; Grade 2 Mild (slightly noticeable); Grade 3 Between mild and moderate; Grade 4 Moderate; Grade 5 Between moderate and marked; Grade 6 Marked (distinctive); Grade 7 Between marked and severe; Grade 8 Severe (very distinctive). A negative change indicates a reduction from in PIH disease severity score from baseline.
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Time frame: Baseline, at Week 12, Week 16 and Week 20