Clinical trial NCT03664739: Study Comparing the Safety and Efficacy of IDP-120 Gel and IDP-120 Vehicle Gel in the Treatment of Acne Vulgaris
Official title: A Phase 3, Multi-Center, Randomized, Double-Blind, Vehicle-Controlled, 2 Arm, Parallel Group Study Comparing the Safety and Efficacy of IDP-120 Gel and IDP-120 Vehicle Gel in the Treatment of Acne Vulgaris
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Acne Vulgaris
Lead sponsor: Bausch Health Americas, Inc.
Sponsor class: INDUSTRY
First posted: 2018-09-10
Enrollment: 608
Sex: ALL
Minimum age (years): 9
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Multi-Center, Randomized, Double-Blind, Vehicle-Controlled, 2 Arm, Parallel Group Study
Primary purpose: TREATMENT

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

Eligibility criteria: Inclusion Criteria:

1. Male or female at least 9 years of age and older;
2. 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);
3. Subject must have a score of 3 (moderate) or 4 (severe) on the Evaluator's Global Severity Score (EGSS) assessment at the baseline visit;
4. Subjects with facial acne inflammatory lesion (papules, pustules, and nodules) count no less than 20 but no more than 50;
5. Subjects with facial acne non-inflammatory lesion (open and closed comedones) count no less than 25 but no more than 100;
6. Subjects with two or fewer facial nodules

Exclusion Criteria:

1. Use of an investigational drug or device within 30 days of enrollment or participation in a research study concurrent with this study;
2. 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;
3. 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;
4. Subjects with a facial beard or mustache that could interfere with the study assessments;
5. Subjects with more than two (2) facial nodules;
6. Evidence or history of cosmetic-related acne

Primary outcomes:
measure: Absolute Change in Mean Lesion Counts at Week 12
timeFrame: Baseline to Week 12
measure: 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"
timeFrame: Baseline to Week 12
Secondary outcomes:
measure: Percentage Change in Mean Lesion Counts at Week 12
timeFrame: Baseline to Week 12
measure: Percentage of Subjects Who Had at Least a 2-grade Reduction From Baseline at Week 12 in the Evaluator's Global Severity Score (EGSS)
timeFrame: Baseline to Week 12
measure: Percentage Change in Mean Lesion Counts at Week 8
timeFrame: Baseline to Week 8
measure: Percentage Change in Mean Lesion Counts at Week 4
timeFrame: Baseline to Week 4
Other outcomes:
Locations:
city: Mobile
country: United States
facility: Valeant Site 123
state: Alabama
city: Hot Springs
country: United States
facility: Valeant Site 121
state: Arkansas
city: Beverly Hills
country: United States
facility: Valeant Site 120
state: California
city: Encinitas
country: United States
facility: Valeant Site 117
state: California
city: Fremont
country: United States
facility: Valeant Site 107
state: California
city: San Diego
country: United States
facility: Valeant Site 104
state: California
city: Denver
country: United States
facility: Valeant Site 128
state: Colorado
city: Wheat Ridge
country: United States
facility: Valeant Site 115
state: Colorado
city: Clearwater
country: United States
facility: Valeant Site 113
state: Florida
city: North Miami Beach
country: United States
facility: Valeant Site 122
state: Florida
city: West Palm Beach
country: United States
facility: Valeant Site 103
state: Florida
city: Oakbrook Terrace
country: United States
facility: Valeant Site 101
state: Illinois
city: Evansville
country: United States
facility: Valeant Site 124
state: Indiana
city: Louisville
country: United States
facility: Valeant Site 111
state: Kentucky
city: Largo
country: United States
facility: Valeant Site 118
state: Maryland
city: Needham
country: United States
facility: Valeant Site 129
state: Massachusetts
city: Detroit
country: United States
facility: Valeant Site 119
state: Michigan
city: New York
country: United States
facility: Valeant Site 126
state: New York
city: High Point
country: United States
facility: Valeant Site 108
state: North Carolina
city: Oklahoma City
country: United States
facility: Valeant Site 106
state: Oklahoma
city: Austin
country: United States
facility: Valeant Site 109
state: Texas
city: Pflugerville
country: United States
facility: Valeant Site 130
state: Texas
city: San Antonio
country: United States
facility: Valeant Site 105
state: Texas
city: Norfolk
country: United States
facility: Valeant Site 110
state: Virginia
city: Walla Walla
country: United States
facility: Valeant Site 116
state: Washington
city: Markham
country: Canada
facility: Valeant Site 112
state: Ontario
city: Waterloo
country: Canada
facility: Valeant Site 102
state: Ontario
city: Waterloo
country: Canada
facility: Valeant Site 114
state: Ontario
city: Waterloo
country: Canada
facility: Valeant Site 125
state: Ontario
city: Waterloo
country: Canada
facility: Valeant Site 127
state: Ontario
Study officials:
affiliation: Bausch Health Companies
name: Anya Loncaric
role: STUDY_DIRECTOR
References: