A Phase 2, Multicenter, Randomized, Double-Blind, Vehicle Controlled, Parallel-Group, Clinical Study in the Treatment of Acne Vulgaris
NCT ID: NCT03170388
Last Updated: 2021-11-10
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2
741 participants
INTERVENTIONAL
2017-10-05
2019-04-23
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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IDP-126 Gel
Gel
IDP-126 Gel
Gel
IDP-126 Component A
Component A
IDP-126 Component A
Component A
IDP-126 Component B
Component B
IDP-126 Component B
Component B
IDP-126 Component C
Component C
IDP-126 Component C
Component C
IDP-126 Vehicle Gel
Vehicle Gel
IDP-126 Vehicle Gel
Vehicle Gel
Interventions
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IDP-126 Gel
Gel
IDP-126 Component A
Component A
IDP-126 Component B
Component B
IDP-126 Component C
Component C
IDP-126 Vehicle Gel
Vehicle Gel
Eligibility Criteria
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Inclusion Criteria
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
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.
9 Years
99 Years
ALL
No
Sponsors
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Bausch Health Americas, Inc.
INDUSTRY
Responsible Party
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Principal Investigators
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Anya Loncaric
Role: STUDY_DIRECTOR
Bausch Health Americas, Inc.
Locations
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Valeant Site 02
Hot Springs, Arkansas, United States
Valeant Site 07
Fremont, California, United States
Valeant Site 08
Sacramento, California, United States
Valeant Site 09
Denver, Colorado, United States
Valeant Site 11
Boynton Beach, Florida, United States
Valeant Site 13
North Miami Beach, Florida, United States
Valeant Site 12
Sanford, Florida, United States
Valeant Site 10
West Palm Beach, Florida, United States
Valeant Site 15
Marietta, Georgia, United States
Valeant Site 14
Snellville, Georgia, United States
Valeant Site 16
Boise, Idaho, United States
Valeant Site 17
Overland Park, Kansas, United States
Valeant Site 18
Louisville, Kentucky, United States
Valeant Site 19
Louisville, Kentucky, United States
valeant Site 21
Glenn Dale, Maryland, United States
Valeant Site 20
Needham, Massachusetts, United States
Valeant Site 22
Detroit, Michigan, United States
Valeant Site 24
Morristown, New Jersey, United States
Valeant Site 25
Albuquerque, New Mexico, United States
Valeant Site 27
New York, New York, United States
Valeant Site 26
New York, New York, United States
Valeant Site 23
High Point, North Carolina, United States
Valeant Site 28
Gresham, Oregon, United States
Valeant Site 30
Johnston, Rhode Island, United States
Valeant Site 31
Nashville, Tennessee, United States
Valeant Site 32
Austin, Texas, United States
Valeant Site 33
Pflugerville, Texas, United States
valeant Site 34
San Antonio, Texas, United States
Valeant Site 35
Norfolk, Virginia, United States
Valeant Site 01
Winnipeg, Manitoba, Canada
Valeant Site 05
Barrie, Ontario, Canada
Valeant Site 06
Oakville, Ontario, Canada
Valeant Site 04
Peterborough, Ontario, Canada
Valeant Site 03
Waterloo, Ontario, Canada
Countries
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References
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Gold M, Lain T, Harper JC, Baldwin H, Guenin E, Stein Gold L. Efficacy and Safety of Clindamycin Phosphate 1.2%/Adapalene 0.15%/Benzoyl Peroxide 3.1% Gel: Post Hoc Analysis by Baseline Disease Severity. Dermatol Ther (Heidelb). 2025 Jul;15(7):1867-1882. doi: 10.1007/s13555-025-01440-z. Epub 2025 May 16.
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.
Provided Documents
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Document Type: Study Protocol and Statistical Analysis Plan
Other Identifiers
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V01-126A-201
Identifier Type: -
Identifier Source: org_study_id