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
180
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 205
Rogers, Arkansas, United States
Bausch Site 201
Manhattan Beach, California, United States
Bausch Site 207
West Palm Beach, Florida, 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
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Bausch Site 208
Boise, Idaho, United States
Bausch Site 209
Louisville, Kentucky, United States
Bausch Site 202
Brighton, Massachusetts, United States
Bausch Site 212
Detroit, Michigan, United States
Bausch Site 206
New York, New York, United States
Bausch Site 203
Gresham, Oregon, United States
Bausch Site 204
Johnston, Rhode Island, United States
...and 3 more locations