- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03168334
A Phase 3, Vehicle-controlled Efficacy and Safety Study of IDP-123 Lotion in the Treatment of Acne Vulgaris (302)
March 30, 2021 updated by: Bausch Health Americas, Inc.
A Phase 3, Multi-Center, Randomized, Double-Blind, Vehicle-Controlled, 2 Arm, Parallel Group Study Comparing the Safety and Efficacy of IDP-123 Lotion and IDP-123 Vehicle Lotion in the Treatment of Acne Vulgaris
This is a multi-center, randomized, double-blind, vehicle-controlled, 12-week study designed to assess the safety, efficacy, and tolerability of IDP-123 Lotion in comparison with IDP-123 Vehicle Lotion.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
This is a multi-center, randomized, double-blind, vehicle-controlled, 12-week study designed to assess the safety, efficacy, and tolerability of IDP-123 Lotion and IDP-123 Vehicle Lotion.
To be eligible for the study subjects must be at least 9 years of age and have a clinical diagnosis of moderate to severe acne.
Study Type
Interventional
Enrollment (Actual)
801
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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British Columbia
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Surrey, British Columbia, Canada, V3VOC6
- Valeant Site 01
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Manitoba
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Winnipeg, Manitoba, Canada, R3M3Z4
- Valeant Site 45
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Ontario
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Windsor, Ontario, Canada, N8W5L7
- Valeant Site 40
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Quebec
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Saint-Jérôme, Quebec, Canada, J7Z3B8
- Valeant Site 17
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Alabama
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Mobile, Alabama, United States, 36608
- Valeant Site 41
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Arkansas
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Rogers, Arkansas, United States, 72758
- Valeant Site 22
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California
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Carlsbad, California, United States, 92008
- Valeant Site 34
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Fremont, California, United States, 94538
- Valeant Site 12
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San Diego, California, United States, 92123
- Valeant Site 06
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San Diego, California, United States, 92123
- Valeant Site 13
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San Diego, California, United States, 92123
- Valeant Site 31
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Santa Ana, California, United States, 92701
- Valeant Site 36
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Colorado
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Denver, Colorado, United States, 80220
- Valeant Site 25
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Florida
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Boynton Beach, Florida, United States, 33437
- Valeant Site 05
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Clearwater, Florida, United States, 33761
- Valeant Site 29
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Jupiter, Florida, United States, 33458
- Valeant Site 38
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Miami, Florida, United States, 33144
- Valeant Site 02
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West Palm Beach, Florida, United States, 33406
- Valeant Site 26
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Georgia
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Snellville, Georgia, United States, 30078
- Valeant Site 44
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Kentucky
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Louisville, Kentucky, United States, 40241
- Valeant Site 32
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Maryland
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Rockville, Maryland, United States, 20850
- Valeant Site 19
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Michigan
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Bay City, Michigan, United States, 48706
- Valeant Site 08
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Clarkston, Michigan, United States, 48346
- Valeant Site 30
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Clinton Township, Michigan, United States, 48038
- Valeant Site 37
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Fort Gratiot, Michigan, United States, 48059
- Valeant Site 20
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Minnesota
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Fridley, Minnesota, United States, 55432
- Valeant Site 24
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New Jersey
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Morristown, New Jersey, United States, 07960
- Valeant Site 03
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New Mexico
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Albuquerque, New Mexico, United States, 87106
- Valeant Site 42
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New York
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New York, New York, United States, 10155
- Valeant Site 10
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Rochester, New York, United States, 14623
- Valeant Site 43
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Stony Brook, New York, United States, 11790
- Valeant Site 33
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Oklahoma
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Oklahoma City, Oklahoma, United States, 73112
- Valeant Site 11
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Pennsylvania
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Broomall, Pennsylvania, United States, 19008
- Valeant Site 28
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Rhode Island
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Warwick, Rhode Island, United States, 02886
- Valeant Site 16
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Tennessee
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Knoxville, Tennessee, United States, 37922
- Valeant Site 18
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Murfreesboro, Tennessee, United States, 37130
- Valeant Site 14
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Texas
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College Station, Texas, United States, 77845
- Valeant Site 23
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Dallas, Texas, United States, 75234
- Valeant Site 07
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Pflugerville, Texas, United States, 78660
- Valeant Site 27
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San Antonio, Texas, United States, 78218
- Valeant Site 04
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Sugar Land, Texas, United States, 77479
- Valeant Site 39
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Utah
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Layton, Utah, United States, 84041
- Valeant Site 09
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West Jordan, Utah, United States, 84088
- Valeant Site 15
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Virginia
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Charlottesville, Virginia, United States, 22911
- Valeant Site 21
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Washington
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Walla Walla, Washington, United States, 99362
- Valeant Site 35
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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 to 99 years (Child, Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Male or female at least 9 years of age and older;
- 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);
- Subject must have a score of 3 (moderate) or 4 (severe) on the Evaluator's Global Severity assessment at the baseline visit;
- Subjects with facial acne inflammatory lesion (papules, pustules, and nodules) count no less than 20 but no more than 50;
- Subjects with facial acne non-inflammatory lesion (open and closed comedones) count no less than 25 but no more than 100;
- Subjects with two or fewer facial nodules
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, dermatitis, eczema;
- 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;
- Subjects with a facial beard or mustache that could interfere with the study assessments;
- Subjects with more than two (2) facial nodules;
- Evidence or history of cosmetic-related acne
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: Triple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: IDP-123 Lotion
Tazarotene 0.045% Lotion
|
Tazarotene 0.045% Lotion
Other Names:
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Placebo Comparator: IDP-123 Vehicle Lotion
Vehicle Lotion
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Vehicle Lotion
Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Absolute Change in Mean Lesion Counts at Week 12
Time Frame: Baseline to Week 12
|
For noninflammatory facial lesions, open comedones (blackheads) and closed comedones (whiteheads) were recorded as a single count.
For inflammatory facial lesions, papules (solid, elevated lesion less than 5 mm) and pustules (elevated lesion containing pus less than 5 mm) were recorded as a single count, while nodular lesions (palpable subcutaneous lesion greater than 5 mm) were counted and recorded separately.
|
Baseline to Week 12
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Percentage of Subjects Who Had at Least a 2-grade Reduction From Baseline at Week 12 in the Evaluator's Global Severity Score (EGSS) and Had an EGSS at Week 12 That Equated to "Clear" or "Almost Clear"
Time Frame: Baseline to Week 12
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Evaluator's Global Severity Score (EGSS) was determined based on evaluator-blinded evaluations of the signs and symptoms of acne vulgaris.
Evaluations were scored on a scale of 0-4, with 0 being clear and 4 being severe.
|
Baseline to Week 12
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Percentage Change in Mean Lesion Counts at Week 12
Time Frame: Baseline to Week 12
|
For noninflammatory facial lesions, open comedones (blackheads) and closed comedones (whiteheads) were recorded as a single count.
For inflammatory facial lesions, papules (solid, elevated lesion less than 5 mm) and pustules (elevated lesion containing pus less than 5 mm) were recorded as a single count, while nodular lesions (palpable subcutaneous lesion greater than 5 mm) were counted and recorded separately.
|
Baseline to Week 12
|
Percentage of Subjects Who Had at Least a 2-grade Reduction From Baseline at Week 12 in the Evaluator's Global Severity Score (EGSS)
Time Frame: Baseline to Week 12
|
Evaluator's Global Severity Score (EGSS) was determined based on evaluator-blinded evaluations of the signs and symptoms of acne vulgaris.
Evaluations were scored on a scale of 0-4, with 0 being clear and 4 being severe.
|
Baseline to Week 12
|
Percentage Change in Mean Lesion Counts at Week 8
Time Frame: Baseline to Week 8
|
For noninflammatory facial lesions, open comedones (blackheads) and closed comedones (whiteheads) were recorded as a single count.
For inflammatory facial lesions, papules (solid, elevated lesion less than 5 mm) and pustules (elevated lesion containing pus less than 5 mm) were recorded as a single count, while nodular lesions (palpable subcutaneous lesion greater than 5 mm) were counted and recorded separately.
|
Baseline to Week 8
|
Percentage Change in Mean Lesion Counts at Week 4
Time Frame: Baseline to Week 4
|
For noninflammatory facial lesions, open comedones (blackheads) and closed comedones (whiteheads) were recorded as a single count.
For inflammatory facial lesions, papules (solid, elevated lesion less than 5 mm) and pustules (elevated lesion containing pus less than 5 mm) were recorded as a single count, while nodular lesions (palpable subcutaneous lesion greater than 5 mm) were counted and recorded separately.
|
Baseline to Week 4
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
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)
July 11, 2017
Primary Completion (Actual)
July 24, 2018
Study Completion (Actual)
July 24, 2018
Study Registration Dates
First Submitted
May 24, 2017
First Submitted That Met QC Criteria
May 24, 2017
First Posted (Actual)
May 30, 2017
Study Record Updates
Last Update Posted (Actual)
April 1, 2021
Last Update Submitted That Met QC Criteria
March 30, 2021
Last Verified
March 1, 2021
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- V01-123A-302
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.
Clinical Trials on Acne Vulgaris
-
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-
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Assiut UniversityCompleted
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Sebacia, Inc.CompletedFacial Acne VulgarisDenmark, Switzerland
Clinical Trials on IDP-123 Lotion
-
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Bausch Health Americas, Inc.Completed
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Bausch Health Americas, Inc.Dow Pharmaceutical SciencesCompleted
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Bausch Health Americas, Inc.Completed
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Valeant PharmaceuticalsUnknown
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Bausch Health Americas, Inc.Dow Pharmaceutical SciencesCompleted
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Valeant PharmaceuticalsUnknown
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Bausch Health Americas, Inc.Completed