Efficacy and Safety of IDP-121 and IDP-121 Vehicle Lotion in the Treatment of Acne Vulgaris
NCT ID: NCT02932306
Last Updated: 2020-01-03
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
820 participants
INTERVENTIONAL
2015-11-03
2017-02-22
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).
* Participant must have a score of 3 (moderate) or 4 (severe) on the EGSS assessment at the screening and baseline visit
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, gram-negative 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.
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 36
Guntersville, Alabama, United States
Valeant Site 14
Phoenix, Arizona, United States
Valeant Site 28
Hot Springs, Arkansas, United States
Valeant Site 38
Fountain Valley, California, United States
Valeant Site 34
Manhattan Beach, California, United States
Valeant Site 23
Oceanside, California, United States
Valeant Site 35
Rancho Cucamonga, California, United States
Valeant Site 20
San Diego, California, United States
Valeant Site 32
Denver, Colorado, United States
Valeant Site 10
Shelton, Connecticut, United States
Valeant Site 02
Boynton Beach, Florida, United States
Valeant Site 15
Coral Gables, Florida, United States
Valeant Site 37
Miami, Florida, United States
Valeant Site 39
Pembroke Pines, Florida, United States
Valeant Site 01
West Palm Beach, Florida, United States
Valeant Site 19
Boise, Idaho, United States
Valeant Site 04
Arlington Heights, Illinois, United States
Valeant Site 27
Carmel, Indiana, United States
Valeant 12
Plainfield, Indiana, United States
Valeant Site 09
Louisville, Kentucky, United States
Valeant Site 16
Louisville, Kentucky, United States
Valeant Site 33
Needham, Massachusetts, United States
Valeant Site 11
Warren, Michigan, United States
Valeant Site 08
Omaha, Nebraska, United States
Valeant Site 25
Omaha, Nebraska, United States
Valeant Site 13
Berlin, New Jersey, United States
Valeant Site 03
Albuquerque, New Mexico, United States
Valeant Site 26
New York, New York, United States
Valeant Site 31
Stony Brook, New York, United States
Valeant 05
Gresham, Oregon, United States
Valeant Site 22
Fort Washington, Pennsylvania, United States
Valeant Site 24
Charleston, South Carolina, United States
Valeant Site 06
Dallas, Texas, United States
Valeant Site 30
Houston, Texas, United States
Valeant Site 17
Pflugerville, Texas, United States
Valeant Site 07
San Antonio, Texas, United States
Valeant 18
Webster, Texas, United States
Valeant Site 29
Salt Lake City, Utah, United States
Valeant Site 21
Norfolk, Virginia, 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-301
Identifier Type: -
Identifier Source: org_study_id
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