This is a multicenter, randomized, double-blind, vehicle-controlled, 12-week study designed to assess the safety, tolerability, and efficacy of IDP-126 Gel in comparison IDP-126 Vehicle Gel at Weeks 2, 4, 8, and 12.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
183
IDP-126 Gel applied topically to the face once daily for 12 weeks.
IDP-126 Vehicle Gel applied topically to the face once daily for 12 weeks.
Bausch Site 110
Bryant, Arkansas, United States
Bausch Site 104
Fremont, California, United States
Bausch Site 109
Denver, Colorado, United States
Absolute Change From Baseline to Week 12 in Inflammatory Lesion Counts
Time frame: 12 weeks
Absolute Change From Baseline to Week 12 in Non-inflammatory Lesion Counts
Time frame: 12 weeks
Percentage of Participants With Success on the Evaluator's Global Severity Score
Success was defined as at least a two grade reduction and clear or almost clear at Week 12. The Evaluator's Global Severity Score has grades for acne severity of 0 (Clear), 1 (Almost Clear), 2 (Mild), 3 (Moderate), and 4 (Severe), with higher scores indicating worse severity.
Time frame: 12 weeks
Inflammatory Lesion Count Percentage Changes at Week 4, 8, and 12
Time frame: Baseline to Week 4, 8, 12
Noninflammatory Lesion Count Percentage Changes at Week 4, 8, and 12
Time frame: Baseline to Week 4, 8, 12
Percentage of Participants With at Least a Two Grade Reduction on the Evaluator's Global Severity Score at Week 12
The Evaluator's Global Severity Score has grades for acne severity of 0 (Clear), 1 (Almost Clear), 2 (Mild), 3 (Moderate), and 4 (Severe), with higher scores indicating worse severity.
Time frame: 12 weeks
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Bausch Site 102
Boynton Beach, Florida, United States
Bausch Site 111
North Miami Beach, Florida, United States
Bausch Site 106
Sanford, Florida, United States
Bausch Site 103
Las Vegas, Nevada, United States
Bausch Site 114
New York, New York, United States
Bausch Site 105
High Point, North Carolina, United States
Bausch Site 107
Nashville, Tennessee, United States
...and 3 more locations