Study to Compare the Safety and Efficacy of IDP-126 Gel to Epiduo® Forte Gel and Vehicle Gel
- Conditions
- Acne Vulgaris
- Interventions
- Registration Number
- NCT04892706
- Lead Sponsor
- Bausch Health Americas, Inc.
- Brief Summary
The safety and efficacy of once daily application of IDP 126 Gel will be compared to Epiduo® Forte and IDP-126 Vehicle Gel.
- Detailed Description
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 with Epiduo® Forte gel and IDP-126 Vehicle Gel at Weeks 2, 4, 8, and 12. To be eligible for the study, subjects must be at least 12 years of age and have a clinical diagnosis of moderate to severe acne (defined as an Evaluator's Global Severity Score \[EGSS\] of 3 or 4), presenting with 30-100 inflammatory facial lesions (papules, pustules, and nodules), 35-150 non-inflammatory facial lesions (open and closed comedones), and ≤ 2 facial nodules.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 686
- Male or female at least 12 years of age and older.
- Written and verbal informed consent must be obtained. Subjects less than age of consent must sign an assent for the study and a parent or a legal guardian must sign the informed consent (if subject reaches age of consent during the study they should be re-consented at the next study visit).
- Subject must have an EGSS of 3 (moderate) or 4 (severe) at the baseline visit.
- Subjects with a facial acne inflammatory lesion (papules, pustules, and nodules) count no less than 30, but no more than 100.
- Subjects with a facial acne non-inflammatory lesion (open and closed comedones) count no less than 35, but no more than 150.
- Subjects with 2 or fewer facial nodules.
- Any dermatological conditions on the face that could interfere with clinical evaluations such as acne conglobata, acne fulminans, secondary acne, perioral dermatitis, clinically significant rosacea, gram negative folliculitis, dermatitis, eczema.
- Any underlying disease(s) or some other dermatological condition of the face that requires the use of interfering topical or systemic therapy or makes evaluations and lesion count inconclusive.
- Subjects with more than 2 facial nodules.
- Female subjects who are pregnant, nursing mothers, planning a pregnancy during the course of the study, or become pregnant during the study.
- Use of estrogens (eg, Depogen, Depo-Testadiol, Gynogen, Valergen, etc) for less than 12 weeks immediately preceding study entry; subjects treated with estrogens 12 or more consecutive weeks immediately prior to study entry need not be excluded unless the subject expects to change dose, drug or discontinue estrogen use during the study.
- Treatment of any type of cancer within the last 6 months, with the exception of complete surgical excision of skin cancer outside the treatment area.
- Subjects who have not undergone specified washout period(s) for topical preparations/physical treatments used on the face or subjects who require the concurrent use in the treatment area.
- Subjects who have not undergone specified washout period(s) for systemic medications or subjects who require the concurrent use of systemic medications.
- Subjects with any underlying disease that the investigator deems uncontrolled, and poses a concern for the subject's safety while participating in the study.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description IDP-126 Gel IDP-126 Gel - IDP-126 Vehicle Gel IDP-126 Vehicle Gel - Epiduo® Forte Gel Epiduo® Forte Gel -
- Primary Outcome Measures
Name Time Method Percentage of subjects who achieve at least a two-grade reduction from baseline and are "Clear" or "Almost Clear" at Week 12 in the Evaluator's Global Severity Score. Baseline to Week 12 EGSS evaluations will be scored on a scale of 0-4, with 0 being clear and 4 being severe.
Absolute change from Baseline to Week 12 in lesion counts. Baseline to Week 12
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (42)
Bausch Site 142
🇺🇸High Point, North Carolina, United States
Bausch Site 110
🇺🇸Fremont, California, United States
Bausch Site 135
🇺🇸North Miami Beach, Florida, United States
Bausch Site 133
🇺🇸New York, New York, United States
Bausch Site 101
🇺🇸Manhattan Beach, California, United States
Bausch Site 143
🇺🇸Sanford, Florida, United States
Bausch Site 118
🇺🇸Rogers, Arkansas, United States
Bausch Site 124
🇺🇸Newnan, Georgia, United States
Bausch Site 119
🇺🇸New York, New York, United States
Bausch Site 105
🇺🇸Boynton Beach, Florida, United States
Bausch Site 123
🇺🇸Pflugerville, Texas, United States
Bausch Site 130
🇨🇦Waterloo, Ontario, Canada
Bausch Site 134
🇺🇸Bryant, Arkansas, United States
Bausch Site 116
🇺🇸Rockville, Maryland, United States
Bausch Site 107
🇺🇸Gresham, Oregon, United States
Bausch Site 111
🇺🇸Austin, Texas, United States
Bausch Site 132
🇺🇸Houston, Texas, United States
Bausch Site 137
🇺🇸Spokane, Washington, United States
Bausch Site 140
🇧🇪Maldegem, Belgium
Bausch Site 136
🇧🇪Kortrijk, Belgium
Bausch Site 141
🇨🇦Oakville, Ontario, Canada
Bausch Site 113
🇨🇦Saint-Jérôme, Quebec, Canada
Bausch Site 115
🇨🇦Peterborough, Ontario, Canada
Bausch Site 112
🇺🇸San Diego, California, United States
Bausch Site 128
🇺🇸San Diego, California, United States
Bausch Site 104
🇺🇸West Palm Beach, Florida, United States
Bausch Site 106
🇺🇸San Diego, California, United States
Bausch Site 122
🇺🇸West Palm Beach, Florida, United States
Bausch Site 125
🇨🇦Markham, Ontario, Canada
Bausch Site 126
🇺🇸Clearwater, Florida, United States
Bausch Site 127
🇺🇸Boise, Idaho, United States
Bausch Site 120
🇺🇸New Brighton, Minnesota, United States
Bausch Site 109
🇺🇸Dublin, Ohio, United States
Bausch Site 108
🇺🇸Las Vegas, Nevada, United States
Bausch Site 138
🇨🇦Winnipeg, Manitoba, Canada
Bausch Site 114
🇺🇸Nashville, Tennessee, United States
Bausch Site 117
🇺🇸Oklahoma City, Oklahoma, United States
Bausch Site 139
🇺🇸Mandeville, Louisiana, United States
Bausch Site 121
🇺🇸Metairie, Louisiana, United States
Bausch Site 102
🇺🇸Tampa, Florida, United States
Bausch Site 103
🇺🇸Brighton, Massachusetts, United States
Bausch Site 129
🇺🇸Louisville, Kentucky, United States