Clinical trial NCT03168334: A Phase 3, Vehicle-controlled Efficacy and Safety Study of IDP-123 Lotion in the Treatment of Acne Vulgaris (302)
Official title: A Phase 3, Multi-Center, Randomized, Double-Blind, Vehicle-Controlled, 2 Arm, Parallel Group Study Comparing the Safety and Efficacy of IDP-123 Lotion and IDP-123 Vehicle Lotion 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: 2017-05-30
Enrollment: 801
Sex: ALL
Minimum age (years): 9
Maximum age (years): 99
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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 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.

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 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 41
state: Alabama
city: Rogers
country: United States
facility: Valeant Site 22
state: Arkansas
city: Carlsbad
country: United States
facility: Valeant Site 34
state: California
city: Fremont
country: United States
facility: Valeant Site 12
state: California
city: San Diego
country: United States
facility: Valeant Site 06
state: California
city: San Diego
country: United States
facility: Valeant Site 13
state: California
city: San Diego
country: United States
facility: Valeant Site 31
state: California
city: Santa Ana
country: United States
facility: Valeant Site 36
state: California
city: Denver
country: United States
facility: Valeant Site 25
state: Colorado
city: Boynton Beach
country: United States
facility: Valeant Site 05
state: Florida
city: Clearwater
country: United States
facility: Valeant Site 29
state: Florida
city: Jupiter
country: United States
facility: Valeant Site 38
state: Florida
city: Miami
country: United States
facility: Valeant Site 02
state: Florida
city: West Palm Beach
country: United States
facility: Valeant Site 26
state: Florida
city: Snellville
country: United States
facility: Valeant Site 44
state: Georgia
city: Louisville
country: United States
facility: Valeant Site 32
state: Kentucky
city: Rockville
country: United States
facility: Valeant Site 19
state: Maryland
city: Bay City
country: United States
facility: Valeant Site 08
state: Michigan
city: Clarkston
country: United States
facility: Valeant Site 30
state: Michigan
city: Clinton Township
country: United States
facility: Valeant Site 37
state: Michigan
city: Fort Gratiot
country: United States
facility: Valeant Site 20
state: Michigan
city: Fridley
country: United States
facility: Valeant Site 24
state: Minnesota
city: Morristown
country: United States
facility: Valeant Site 03
state: New Jersey
city: Albuquerque
country: United States
facility: Valeant Site 42
state: New Mexico
city: New York
country: United States
facility: Valeant Site 10
state: New York
city: Rochester
country: United States
facility: Valeant Site 43
state: New York
city: Stony Brook
country: United States
facility: Valeant Site 33
state: New York
city: Oklahoma City
country: United States
facility: Valeant Site 11
state: Oklahoma
city: Broomall
country: United States
facility: Valeant Site 28
state: Pennsylvania
city: Warwick
country: United States
facility: Valeant Site 16
state: Rhode Island
city: Knoxville
country: United States
facility: Valeant Site 18
state: Tennessee
city: Murfreesboro
country: United States
facility: Valeant Site 14
state: Tennessee
city: College Station
country: United States
facility: Valeant Site 23
state: Texas
city: Dallas
country: United States
facility: Valeant Site 07
state: Texas
city: Pflugerville
country: United States
facility: Valeant Site 27
state: Texas
city: San Antonio
country: United States
facility: Valeant Site 04
state: Texas
city: Sugar Land
country: United States
facility: Valeant Site 39
state: Texas
city: Layton
country: United States
facility: Valeant Site 09
state: Utah
city: West Jordan
country: United States
facility: Valeant Site 15
state: Utah
city: Charlottesville
country: United States
facility: Valeant Site 21
state: Virginia
city: Walla Walla
country: United States
facility: Valeant Site 35
state: Washington
city: Surrey
country: Canada
facility: Valeant Site 01
state: British Columbia
city: Winnipeg
country: Canada
facility: Valeant Site 45
state: Manitoba
city: Windsor
country: Canada
facility: Valeant Site 40
state: Ontario
city: Saint-Jérôme
country: Canada
facility: Valeant Site 17
state: Quebec
Study officials:
affiliation: Valeant Pharmaceuticals
name: Anya Loncaric
role: STUDY_DIRECTOR
References: