- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02932306
Efficacy and Safety of IDP-121 and IDP-121 Vehicle Lotion in the Treatment of Acne Vulgaris
December 16, 2019 updated by: Bausch Health Americas, Inc.
A Phase 3, Multi-Center, Randomized, Double-Blind, Vehicle- Controlled, 2-Arm, Parallel Group Comparison Study Comparing the Efficacy and Safety of IDP-121 and IDP-121 Vehicle Lotion in the Treatment of Acne Vulgaris
The objective of this study was to evaluate the efficacy, safety, and tolerability of a once daily topical application of IDP-121 Lotion compared with its vehicle (IDP-121 Vehicle Lotion) in participants with moderate to severe acne vulgaris (acne) (that is, acne having an Evaluator's Global Severity Score [EGSS] of 3 [moderate] or 4 [severe]).
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
820
Phase
- Phase 3
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Alabama
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Guntersville, Alabama, United States, 35976
- Valeant Site 36
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Arizona
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Phoenix, Arizona, United States, 85032
- Valeant Site 14
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Arkansas
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Hot Springs, Arkansas, United States, 71913
- Valeant Site 28
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California
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Fountain Valley, California, United States, 92708
- Valeant Site 38
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Manhattan Beach, California, United States, 90266
- Valeant Site 34
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Oceanside, California, United States, 92056
- Valeant Site 23
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Rancho Cucamonga, California, United States, 91730
- Valeant Site 35
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San Diego, California, United States, 92123
- Valeant Site 20
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Colorado
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Denver, Colorado, United States, 80220
- Valeant Site 32
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Connecticut
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Shelton, Connecticut, United States, 06484
- Valeant Site 10
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Florida
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Boynton Beach, Florida, United States, 33437
- Valeant Site 02
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Coral Gables, Florida, United States, 33146
- Valeant Site 15
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Miami, Florida, United States, 33142
- Valeant Site 37
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Pembroke Pines, Florida, United States, 33028
- Valeant Site 39
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West Palm Beach, Florida, United States, 33401
- Valeant Site 01
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Idaho
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Boise, Idaho, United States, 83704
- Valeant Site 19
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Illinois
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Arlington Heights, Illinois, United States, 60005
- Valeant Site 04
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Indiana
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Carmel, Indiana, United States, 46032
- Valeant Site 27
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Plainfield, Indiana, United States, 46168
- Valeant 12
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Kentucky
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Louisville, Kentucky, United States, 40202
- Valeant Site 09
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Louisville, Kentucky, United States, 40217
- Valeant Site 16
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Massachusetts
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Needham, Massachusetts, United States, 02492
- Valeant Site 33
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Michigan
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Warren, Michigan, United States, 48088
- Valeant Site 11
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Nebraska
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Omaha, Nebraska, United States, 68114
- Valeant Site 08
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Omaha, Nebraska, United States, 68144
- Valeant Site 25
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New Jersey
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Berlin, New Jersey, United States, 08009
- Valeant Site 13
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New Mexico
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Albuquerque, New Mexico, United States, 87106
- Valeant Site 03
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New York
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New York, New York, United States, 10022
- Valeant Site 26
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Stony Brook, New York, United States, 11790
- Valeant Site 31
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Oregon
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Gresham, Oregon, United States, 97030
- Valeant 05
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Pennsylvania
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Fort Washington, Pennsylvania, United States, 19034
- Valeant Site 22
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South Carolina
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Charleston, South Carolina, United States, 29414
- Valeant Site 24
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Texas
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Dallas, Texas, United States, 75231
- Valeant Site 06
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Houston, Texas, United States, 77004
- Valeant Site 30
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Pflugerville, Texas, United States, 78660
- Valeant Site 17
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San Antonio, Texas, United States, 78229
- Valeant Site 07
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Webster, Texas, United States, 77598
- Valeant 18
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Utah
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Salt Lake City, Utah, United States, 84117
- Valeant Site 29
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Virginia
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Norfolk, Virginia, United States, 23502
- Valeant Site 21
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
9 years and older (Child, Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Key Inclusion Criteria:
- Male or female at least 9 years of age and older.
- 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
Key Exclusion Criteria:
- Use of an investigational drug or device within 30 days of enrollment or participation in a research study concurrent with this study.
- 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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Quadruple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
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Experimental: 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.
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IDP-121 lotion will be applied as per the instructions provided by the investigational center staff.
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Placebo Comparator: 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.
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IDP-121 vehicle lotion will be applied as per the instructions provided by the investigational center staff.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Absolute Change From Baseline in Mean Noninflammatory Lesion Count to Week 12
Time Frame: Baseline (Day 0), Week 12
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Noninflammatory lesions were defined as follows: Open comedones (blackhead) - plugged hair follicle with dilated/open orifice, black in color; and Closed comedones (whitehead) - plugged hair follicle: small opening at skin surface.
For noninflammatory facial lesions, open and closed comedones were recorded as a single count.
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Baseline (Day 0), Week 12
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Absolute Change From Baseline in Mean Inflammatory Lesion Count to Week 12
Time Frame: Baseline, Week 12
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Inflammatory lesions were defined as follows: Papule - a solid, elevated lesion less than 5 millimeters (mm); and Pustule - an elevated lesion containing pus less than 5 mm.
For inflammatory facial lesions, papules and pustules were recorded as a single count, while nodular lesions were counted and recorded separately.
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Baseline, Week 12
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Percentage of Participants With Treatment Success at Week 12
Time Frame: Baseline, Week 12
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Treatment success was defined as at least a 2-grade reduction from Baseline in EGSS score and an EGSS score equating to "Clear" or "Almost Clear".
EGSS was based on a 5-point scale ranging from 0 to 4; where 0 = clear, 1 = almost clear, 2 = mild, 3 = moderate, and 4 = severe.
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Baseline, Week 12
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Percent Change From Baseline in Noninflammatory Lesion Count to Week 12
Time Frame: Baseline, Week 12
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Noninflammatory lesions were defined as follows: Open comedones (blackhead) - plugged hair follicle with dilated/open orifice, black in color; and Closed comedones (whitehead) - plugged hair follicle: small opening at skin surface.
For noninflammatory facial lesions, open and closed comedones were recorded as a single count.
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Baseline, Week 12
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Percent Change From Baseline in Inflammatory Lesion Count to Week 12
Time Frame: Baseline, Week 12
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Inflammatory lesions were defined as follows: Papule - a solid, elevated lesion less than 5 millimeters (mm); and Pustule - an elevated lesion containing pus less than 5 mm.
For inflammatory facial lesions, papules and pustules were recorded as a single count, while nodular lesions were counted and recorded separately.
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Baseline, Week 12
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Study Chair: Tim Theisen, TKL Research, Inc.
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
November 3, 2015
Primary Completion (Actual)
February 22, 2017
Study Completion (Actual)
February 22, 2017
Study Registration Dates
First Submitted
October 11, 2016
First Submitted That Met QC Criteria
October 11, 2016
First Posted (Estimate)
October 13, 2016
Study Record Updates
Last Update Posted (Actual)
January 3, 2020
Last Update Submitted That Met QC Criteria
December 16, 2019
Last Verified
December 1, 2019
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- V01-121A-301
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Undecided
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Yes
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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Bausch Health Americas, Inc.Completed
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Bausch Health Americas, Inc.Completed
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IDP Discovery Pharma S.L.RecruitingChronic Lymphocytic Leukemia (CLL) | Diffuse Large B-Cell Lymphoma, Not Otherwise Specified | Multiple Myeloma (MM) | High Grade B-Cell Lymphoma, Not Otherwise Specified | Double Hit Lymphoma | Triple Hit LymphomaSpain
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