Study Comparing the Safety and Efficacy of IDP-120 Gel and IDP-120 Vehicle Gel in the Treatment of Acne Vulgaris
- Conditions
- Acne Vulgaris
- Interventions
- Drug: IDP-120 GelDrug: IDp-120 Vehicle Gel
- Registration Number
- NCT03664739
- Lead Sponsor
- Bausch Health Americas, Inc.
- Brief Summary
study designed to assess the safety, tolerability, and efficacy of IDP-120 Gel and IDP-120 Vehicle Gel
- Detailed Description
This is a multi-center, randomized, double-blind, vehicle-controlled, 12-week study designed to assess the safety, tolerability, and efficacy of IDP-120 Gel and IDP-120 Vehicle Gel at Weeks 2, 4, 8, and 12. To be eligible for the study subjects must be at least 9 years of age and have a clinical diagnosis of moderate to severe acne
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 608
- Male or female at least 9 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 a score of 3 (moderate) or 4 (severe) on the Evaluator's Global Severity Score (EGSS) assessment at the baseline visit;
- Subjects with facial acne inflammatory lesion (papules, pustules, and nodules) count no less than 20 but no more than 50;
- Subjects with facial acne non-inflammatory lesion (open and closed comedones) count no less than 25 but no more than 100;
- Subjects with two or fewer facial nodules
- Use of an investigational drug or device within 30 days of enrollment or participation in a research study concurrent with this study;
- 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 a facial beard or mustache that could interfere with the study assessments;
- Subjects with more than two (2) facial nodules;
- Evidence or history of cosmetic-related acne
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description IDP-120 Gel IDP-120 Gel IDP-120 Gel, once-daily application IDP-120 Vehicle Gel IDp-120 Vehicle Gel IDP-120 Vehicle Gel, once-daily application
- Primary Outcome Measures
Name Time Method Percentage of Subjects Who Had at Least a 2-grade Reduction From Baseline at Week 12 in the Evaluator's Global Severity Score (EGSS) and Had an EGSS at Week 12 That Equated to "Clear" or "Almost Clear" Baseline to Week 12 Evaluator's Global Severity Score (EGSS) was determined based on evaluator-blinded evaluations of the signs and symptoms of acne vulgaris. Evaluations were scored on a scale of 0-4, with 0 being clear and 4 being severe.
Absolute Change in Mean Lesion Counts at Week 12 Baseline to Week 12 For noninflammatory facial lesions, open comedones (blackheads) and closed comedones (whiteheads) were recorded as a single count. For inflammatory facial lesions, papules (solid, elevated lesion less than 5 mm) and pustules (elevated lesion containing pus less than 5 mm) were recorded as a single count, while nodular lesions (palpable subcutaneous lesion greater than 5 mm) were counted and recorded separately.
- Secondary Outcome Measures
Name Time Method Percentage Change in Mean Lesion Counts at Week 12 Baseline to Week 12 For noninflammatory facial lesions, open comedones (blackheads) and closed comedones (whiteheads) were recorded as a single count. For inflammatory facial lesions, papules (solid, elevated lesion less than 5 mm) and pustules (elevated lesion containing pus less than 5 mm) were recorded as a single count, while nodular lesions (palpable subcutaneous lesion greater than 5 mm) were counted and recorded separately.
Percentage Change in Mean Lesion Counts at Week 8 Baseline to Week 8 For noninflammatory facial lesions, open comedones (blackheads) and closed comedones (whiteheads) were recorded as a single count. For inflammatory facial lesions, papules (solid, elevated lesion less than 5 mm) and pustules (elevated lesion containing pus less than 5 mm) were recorded as a single count, while nodular lesions (palpable subcutaneous lesion greater than 5 mm) were counted and recorded separately.
Percentage of Subjects Who Had at Least a 2-grade Reduction From Baseline at Week 12 in the Evaluator's Global Severity Score (EGSS) Baseline to Week 12 Evaluator's Global Severity Score (EGSS) was determined based on evaluator-blinded evaluations of the signs and symptoms of acne vulgaris. Evaluations were scored on a scale of 0-4, with 0 being clear and 4 being severe.
Percentage Change in Mean Lesion Counts at Week 4 Baseline to Week 4 For noninflammatory facial lesions, open comedones (blackheads) and closed comedones (whiteheads) were recorded as a single count. For inflammatory facial lesions, papules (solid, elevated lesion less than 5 mm) and pustules (elevated lesion containing pus less than 5 mm) were recorded as a single count, while nodular lesions (palpable subcutaneous lesion greater than 5 mm) were counted and recorded separately.
Trial Locations
- Locations (30)
Valeant Site 130
🇺🇸Pflugerville, Texas, United States
Valeant Site 110
🇺🇸Norfolk, Virginia, United States
Valeant Site 118
🇺🇸Largo, Maryland, United States
Valeant Site 107
🇺🇸Fremont, California, United States
Valeant Site 113
🇺🇸Clearwater, Florida, United States
Valeant Site 124
🇺🇸Evansville, Indiana, United States
Valeant Site 120
🇺🇸Beverly Hills, California, United States
Valeant Site 126
🇺🇸New York, New York, United States
Valeant Site 117
🇺🇸Encinitas, California, United States
Valeant Site 125
🇨🇦Waterloo, Ontario, Canada
Valeant Site 102
🇨🇦Waterloo, Ontario, Canada
Valeant Site 114
🇨🇦Waterloo, Ontario, Canada
Valeant Site 115
🇺🇸Wheat Ridge, Colorado, United States
Valeant Site 101
🇺🇸Oakbrook Terrace, Illinois, United States
Valeant Site 122
🇺🇸North Miami Beach, Florida, United States
Valeant Site 116
🇺🇸Walla Walla, Washington, United States
Valeant Site 103
🇺🇸West Palm Beach, Florida, United States
Valeant Site 104
🇺🇸San Diego, California, United States
Valeant Site 105
🇺🇸San Antonio, Texas, United States
Valeant Site 123
🇺🇸Mobile, Alabama, United States
Valeant Site 109
🇺🇸Austin, Texas, United States
Valeant Site 112
🇨🇦Markham, Ontario, Canada
Valeant Site 119
🇺🇸Detroit, Michigan, United States
Valeant Site 106
🇺🇸Oklahoma City, Oklahoma, United States
Valeant Site 127
🇨🇦Waterloo, Ontario, Canada
Valeant Site 128
🇺🇸Denver, Colorado, United States
Valeant Site 129
🇺🇸Needham, Massachusetts, United States
Valeant Site 108
🇺🇸High Point, North Carolina, United States
Valeant Site 111
🇺🇸Louisville, Kentucky, United States
Valeant Site 121
🇺🇸Hot Springs, Arkansas, United States