Efficacy and Safety of IDP-121 and IDP-121 Vehicle Lotion in the Treatment of Acne Vulgaris
NCT ID: NCT02965456
Last Updated: 2019-12-18
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
820 participants
INTERVENTIONAL
2015-11-04
2017-02-23
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
QUADRUPLE
Study Groups
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IDP-121 Lotion
IDP-121 lotion (tretinoin 0.05 percent \[%\]) will be applied topically to the face of participants with moderate to severe acne, once daily for 12 weeks.
IDP 121 Lotion
IDP-121 lotion will be applied as per the instructions provided by the investigational center staff.
IDP-121 Vehicle Lotion
IDP-121 lotion vehicle will be applied topically to the face of participants with moderate to severe acne, once daily for 12 weeks.
IDP-121 Vehicle Lotion
IDP-121 vehicle lotion will be applied as per the instructions provided by the investigational center staff.
Interventions
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IDP 121 Lotion
IDP-121 lotion will be applied as per the instructions provided by the investigational center staff.
IDP-121 Vehicle Lotion
IDP-121 vehicle lotion will be applied as per the instructions provided by the investigational center staff.
Eligibility Criteria
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Inclusion Criteria
* Written and verbal informed consent must be obtained. Participants 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 participant reaches age of consent during the study they should be re-consented at the next study visit).
* Participants must be willing to comply with study instructions and return to the study center for required visits. Participants under the age of consent must be accompanied by the parent or legal guardian at the time of assent/consent signing.
* If a cleanser, moisturizer or sunscreen is needed during the study, participants must be willing to use only allowed cleansers, moisturizers, sunscreens, or moisturizer/sunscreen combination products. If the participant wears makeup they must agree to use non-comedogenic makeup.
Exclusion Criteria
* 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, gramnegative folliculitis.
* 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.
* Participants with a facial beard or mustache that could interfere with the study assessments.
* History of hypersensitivity or allergic reactions to any of the study preparations as described in the Investigator's Brochure, including known sensitivities to any dosage form of tretinoin.
* Participants who are unable to communicate or cooperate with the Investigator due to language problems, poor mental development, or impaired cerebral function.
* Participants with any underlying disease that the Investigator deems uncontrolled, and poses a concern for the participant's safety while participating in the study.
9 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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Tim Theisen
Role: STUDY_CHAIR
TKL Research, Inc.
Locations
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Valeant Site 21
Glendale, Arizona, United States
Valeant Site 34
Rogers, Arkansas, United States
Valeant Site 25
Anaheim, California, United States
Valeant Site 18
Beverly Hills, California, United States
Valeant Site 09
Fremont, California, United States
Valeant Site 17
Murrieta, California, United States
Valeant Site 26
Oxnard, California, United States
Valeant Site 22
Sacramento, California, United States
Valeant Site 02
San Diego, California, United States
Valeant Site 04
San Diego, California, United States
Valeant Site 19
Santa Monica, California, United States
Valeant Site 15
Miami, Florida, United States
Valeant Site 11
Miami, Florida, United States
Valeant Site 27
Pinellas Park, Florida, United States
Valeant Site 31
Sanford, Florida, United States
Valeant Site 05
Tampa, Florida, United States
Valeant Site 28
Marietta, Georgia, United States
Valeant Site 16
Buffalo Grove, Illinois, United States
Valeant Site 06
Indianapolis, Indiana, United States
Valeant Site 12
Overland Park, Kansas, United States
Valeant Site 32
Crowley, Louisiana, United States
Valeant Site 30
Clarkston, Michigan, United States
Valeant Site 03
Detroit, Michigan, United States
Valeant Site 20
Henderson, Nevada, United States
Valeant Site 08
New York, New York, United States
Valeant Site 23
Winston-Salem, North Carolina, United States
Valeant Site 29
Hazleton, Pennsylvania, United States
Valeant Site 24
Johnston, Rhode Island, United States
Valeant Site 10
Austin, Texas, United States
Valeant Site 01
Houston, Texas, United States
Valeant Site 33
Port Arthur, Texas, United States
Valeant Site 07
San Antonio, Texas, United States
Valeant Site 13
San Antonio, Texas, United States
Valeant Site 14
San Antonio, Texas, United States
Countries
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References
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Tyring SK, Kircik L, Pariser DM, Woolery-Lloyd HC, Harper JC, Bhatt V, Pillai R, Guenin E. The Effects of Once-Daily Tretinoin 0.05% Lotion on Quality of Life in Patients with Moderate-to-Severe Acne Vulgaris. Am J Clin Dermatol. 2020 Dec;21(6):891-899. doi: 10.1007/s40257-020-00559-3.
Provided Documents
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Document Type: Study Protocol and Statistical Analysis Plan
Other Identifiers
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V01-121A-302
Identifier Type: -
Identifier Source: org_study_id