A Phase 3, Vehicle-controlled Efficacy and Safety Study of IDP-123 Lotion in the Treatment of Acne Vulgaris (301)
- Conditions
- Acne Vulgaris
- Interventions
- Drug: IDP-123 Vehicle Lotion
- Registration Number
- NCT03168321
- Lead Sponsor
- Bausch Health Americas, Inc.
- Brief Summary
This is a multicenter, randomized, double-blind, vehicle-controlled, 12-week study designed to assess the safety, efficacy, and tolerability of IDP-123 Lotion in comparison with IDP-123 Vehicle Lotion.
- Detailed Description
This is a multi-center, randomized, double-blind, vehicle-controlled, 12-week study designed to assess the safety, efficacy, and tolerability of IDP-123 Lotion and IDP-123 Vehicle Lotion. 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
- 813
- 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 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 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-123 Lotion IDP-123 Lotion Tazarotene 0.045% Lotion IDP-123 Vehicle Lotion IDP-123 Vehicle Lotion Vehicle Lotion
- Primary Outcome Measures
Name Time Method 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.
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.
- Secondary Outcome Measures
Name Time Method 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 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 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 (45)
Valeant Site 27
🇺🇸Pembroke Pines, Florida, United States
Valeant Site 36
🇺🇸New York, New York, United States
Valeant Site 26
🇺🇸Newnan, Georgia, United States
Valeant Site 23
🇺🇸New Albany, Indiana, United States
Valeant Site 04
🇺🇸La Mesa, California, United States
Valeant Site 01
🇺🇸San Diego, California, United States
Valeant Site 32
🇺🇸Cincinnati, Ohio, United States
Valeant Site 25
🇺🇸San Antonio, Texas, United States
Valeant Site 31
🇺🇸Overland Park, Kansas, United States
Valeant Site 21
🇺🇸Phoenix, Arizona, United States
Valeant Site 38
🇺🇸Detroit, Michigan, United States
valeant Site 14
🇺🇸Nashville, Tennessee, United States
Valeant Site 41
🇺🇸Salt Lake City, Utah, United States
Valeant Site 19
🇺🇸Phoenix, Arizona, United States
Valeant Site 02
🇺🇸Manhattan Beach, California, United States
Valeant Site 24
🇺🇸Hot Springs, Arkansas, United States
Valeant Site 42
🇺🇸Murrieta, California, United States
Valeant Site 37
🇺🇸Wheat Ridge, Colorado, United States
Valeant Site 13
🇺🇸Sanford, Florida, United States
Valeant Site 33
🇺🇸Ormond Beach, Florida, United States
Valeant Site 40
🇺🇸North Miami Beach, Florida, United States
Valeant Site 03
🇺🇸West Palm Beach, Florida, United States
Valeant Site 30
🇺🇸Boise, Idaho, United States
Valeant Site 06
🇺🇸Arlington Heights, Illinois, United States
Valeant Site 17
🇺🇸South Bend, Indiana, United States
Valeant Site 08
🇺🇸Metairie, Louisiana, United States
Valeant Site 16
🇺🇸Warren, Michigan, United States
Valeant site 20
🇺🇸New York, New York, United States
Valeant Site 09
🇺🇸High Point, North Carolina, United States
Valeant Site 11
🇺🇸Dublin, Ohio, United States
valeant Site 07
🇺🇸Gresham, Oregon, United States
Valeant Site 34
🇺🇸Knoxville, Tennessee, United States
Valeant Site 05
🇺🇸Katy, Texas, United States
Valeant Site 18
🇺🇸Plano, Texas, United States
Valeant Site 43
🇺🇸Webster, Texas, United States
Valeant Site 45
🇺🇸Norfolk, Virginia, United States
Valeant Site 29
🇨🇦Peterborough, Ontario, Canada
Valeant Site 44
🇺🇸Spokane, Washington, United States
Valeant Site 28
🇨🇦Waterloo, Ontario, Canada
Valeant Site 10
🇨🇦Laval, Quebec, Canada
Valeant Site 15
🇺🇸Johnston, Rhode Island, United States
Valeant Site 35
🇺🇸Boca Raton, Florida, United States
Valeant Site 39
🇺🇸Sacramento, California, United States
Valeant Site 22
🇺🇸Louisville, Kentucky, United States
Valeant Site 12
🇺🇸Austin, Texas, United States