To evaluate the safety and effectiveness of 3 strengths of P005672-HCl compared to placebo for the treatment of moderate to severe facial acne vulgaris.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
285
P005672-HCl administered as an oral capsule(s) once daily
Dose-matched Placebo capsule administered as an oral capsule(s) once daily
P005672-HCl administered as an oral capsule(s) once daily
The Absolute Change From Baseline in the Inflammatory Lesion Count at the Final Visit
Time frame: Baseline (Week 0) to Final Visit (Up to Week 12)
The Dichotomized IGA (Investigator Global Assessment) Score at Final Visit
The Investigator Global Assessment Scale (IGA) for Acne Vulgaris Score is a 5-point ordinal scale ranging from 0 to 4. The dichotomized IGA score, where success was defined as at least a 2-grade decrease in the IGA score during the Final Visit as compared to the Baseline Visit.
Time frame: Final Visit (Up to Week 12)
The Absolute Change From Baseline in the Inflammatory Lesion Count at Weeks 1, 2, 4, 8, 12 and the Final Visit
Time frame: Baseline (Week 0) up to Week 12
The Absolute Change From Baseline in the Noninflammatory Lesion Count at Weeks 1, 2, 4, 8, 12, and the Final Visit
Time frame: Baseline (Week 0) up to Week 12
The Percent Change From Baseline in the Inflammatory Lesion Count at Weeks 1, 2, 4, 8, 12, and the Final Visit
Time frame: Baseline (Week 0) up to Week 12
The Percent Change From Baseline in the Noninflammatory Lesion Count at Weeks 1, 2, 4, 8, 12, and the Final Visit
Time frame: Baseline (Week 0) up to Week 12
The Dichotomized IGA Score at Weeks 1, 2, 4, 8, and 12
The Investigator Global Assessment Scale (IGA) for Acne Vulgaris Score is a 5-point ordinal scale ranging from 0 to 4. The dichotomized IGA score, where success was defined as at least a 2-grade decrease in the IGA score during the Final Visit as compared to the Baseline Visit.
Time frame: Baseline to Final Visit (Up to Week 12)
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Warner Chilcott Investigational Site
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