Clinical trial NCT03170388: A Phase 2, Multicenter, Randomized, Double-Blind, Vehicle Controlled, Parallel-Group, Clinical Study in the Treatment of Acne Vulgaris
Official title: A Phase 2, Multicenter, Randomized, Double-Blind, Vehicle Controlled, Parallel-Group, Clinical Study Comparing the Efficacy and Safety of IDP-126 Gel in the Treatment of Acne Vulgaris
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Acne Vulgaris
Lead sponsor: Bausch Health Americas, Inc.
Sponsor class: INDUSTRY
First posted: 2017-05-31
Enrollment: 741
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
Intervention model description: Multicenter, Randomized, Double-Blind, Vehicle Controlled, Parallel-Group
Primary purpose: TREATMENT

Brief summary: A Phase 2, Multicenter, Randomized, Double-Blind, Vehicle Controlled, Parallel-Group, Clinical Study in the Treatment of Acne Vulgaris

Detailed description: A Phase 2, Multicenter, Randomized, Double-Blind, Vehicle Controlled, Parallel-Group, Clinical Study Comparing the Efficacy and Safety of IDP-126 Gel in the Treatment of Acne Vulgaris

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 an EGSS of 3 (moderate) or 4 (severe) at the baseline visit.
4. Subjects with a facial acne inflammatory lesion (papules, pustules, and nodules) count no less than 20, but no more than 100.
5. Subjects with a facial acne non-inflammatory lesion (open and closed comedones) count no less than 30, but no more than 150.
6. Subjects with 2 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 2 facial nodules.
6. Evidence or history of cosmetic-related acne.

Primary outcomes:
measure: Inflammatory Lesion Counts
timeFrame: Baseline to Week 12
measure: Non-inflammatory Lesion Counts
timeFrame: Baseline to Week 12
measure: Percentage of Participants With Success on the Evaluator's Global Severity Score
timeFrame: Baseline to Week 12
Secondary outcomes:
measure: Inflammatory Lesion Count Changes at Week 2, 4, and 8
timeFrame: Baseline to Week 2, 4, 8
measure: Non-inflammatory Lesion Count Changes at Week 2, 4, and 8
timeFrame: Baseline to Week 2, 4, 8
measure: Inflammatory Lesion Count Percentage Changes at Week 2, 4, and 8
timeFrame: Baseline to Week 2, 4, 8
measure: Non-inflammatory Lesion Count Percentage Changes at Week 2, 4, and 8
timeFrame: Baseline to Week 2, 4, 8
measure: Percentage of Participants With Success on the Evaluator's Global Severity Score at Weeks 2, 4, and 8
timeFrame: Baseline to Week 2, 4, and 8
measure: Percentage of Participants With Two Grade Success on the Evaluator's Global Severity Score - at Weeks 2, 4, and 8
timeFrame: Baseline to Week 2, 4, and 8
Other outcomes:
Locations:
city: Hot Springs
country: United States
facility: Valeant Site 02
state: Arkansas
city: Fremont
country: United States
facility: Valeant Site 07
state: California
city: Sacramento
country: United States
facility: Valeant Site 08
state: California
city: Denver
country: United States
facility: Valeant Site 09
state: Colorado
city: Boynton Beach
country: United States
facility: Valeant Site 11
state: Florida
city: North Miami Beach
country: United States
facility: Valeant Site 13
state: Florida
city: Sanford
country: United States
facility: Valeant Site 12
state: Florida
city: West Palm Beach
country: United States
facility: Valeant Site 10
state: Florida
city: Marietta
country: United States
facility: Valeant Site 15
state: Georgia
city: Snellville
country: United States
facility: Valeant Site 14
state: Georgia
city: Boise
country: United States
facility: Valeant Site 16
state: Idaho
city: Overland Park
country: United States
facility: Valeant Site 17
state: Kansas
city: Louisville
country: United States
facility: Valeant Site 18
state: Kentucky
city: Louisville
country: United States
facility: Valeant Site 19
state: Kentucky
city: Glenn Dale
country: United States
facility: valeant Site 21
state: Maryland
city: Needham
country: United States
facility: Valeant Site 20
state: Massachusetts
city: Detroit
country: United States
facility: Valeant Site 22
state: Michigan
city: Morristown
country: United States
facility: Valeant Site 24
state: New Jersey
city: Albuquerque
country: United States
facility: Valeant Site 25
state: New Mexico
city: New York
country: United States
facility: Valeant Site 27
state: New York
city: New York
country: United States
facility: Valeant Site 26
state: New York
city: High Point
country: United States
facility: Valeant Site 23
state: North Carolina
city: Gresham
country: United States
facility: Valeant Site 28
state: Oregon
city: Johnston
country: United States
facility: Valeant Site 30
state: Rhode Island
city: Nashville
country: United States
facility: Valeant Site 31
state: Tennessee
city: Austin
country: United States
facility: Valeant Site 32
state: Texas
city: Pflugerville
country: United States
facility: Valeant Site 33
state: Texas
city: San Antonio
country: United States
facility: valeant Site 34
state: Texas
city: Norfolk
country: United States
facility: Valeant Site 35
state: Virginia
city: Winnipeg
country: Canada
facility: Valeant Site 01
state: Manitoba
city: Barrie
country: Canada
facility: Valeant Site 05
state: Ontario
city: Oakville
country: Canada
facility: Valeant Site 06
state: Ontario
city: Peterborough
country: Canada
facility: Valeant Site 04
state: Ontario
city: Waterloo
country: Canada
facility: Valeant Site 03
state: Ontario
Study officials:
affiliation: Bausch Health Americas, Inc.
name: Anya Loncaric
role: STUDY_DIRECTOR
References:
citation: Stein Gold L, Baldwin H, Kircik LH, Weiss JS, Pariser DM, Callender V, Lain E, Gold M, Beer K, Draelos Z, Sadick N, Pillai R, Bhatt V, Tanghetti EA. Efficacy and Safety of a Fixed-Dose Clindamycin Phosphate 1.2%, Benzoyl Peroxide 3.1%, and Adapalene 0.15% Gel for Moderate-to-Severe Acne: A Randomized Phase II Study of the First Triple-Combination Drug. Am J Clin Dermatol. 2022 Jan;23(1):93-104. doi: 10.1007/s40257-021-00650-3. Epub 2021 Oct 21.