- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03170388
A Phase 2, Multicenter, Randomized, Double-Blind, Vehicle Controlled, Parallel-Group, Clinical Study in the Treatment of Acne Vulgaris
October 13, 2021 updated by: Bausch Health Americas, Inc.
A Phase 2, Multicenter, Randomized, Double-Blind, Vehicle Controlled, Parallel-Group, Clinical Study Comparing the Efficacy and Safety of IDP-126 Gel in the Treatment of Acne Vulgaris
A Phase 2, Multicenter, Randomized, Double-Blind, Vehicle Controlled, Parallel-Group, Clinical Study in the Treatment of Acne Vulgaris
Study Overview
Status
Completed
Conditions
Detailed Description
A Phase 2, Multicenter, Randomized, Double-Blind, Vehicle Controlled, Parallel-Group, Clinical Study Comparing the Efficacy and Safety of IDP-126 Gel in the Treatment of Acne Vulgaris
Study Type
Interventional
Enrollment (Actual)
741
Phase
- Phase 2
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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Manitoba
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Winnipeg, Manitoba, Canada, R3M 3Z4
- Valeant Site 01
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Ontario
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Barrie, Ontario, Canada, L4M7G1
- Valeant Site 05
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Oakville, Ontario, Canada, L6J7W5
- Valeant Site 06
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Peterborough, Ontario, Canada, K9J5K2
- Valeant Site 04
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Waterloo, Ontario, Canada, N2J1C4
- Valeant Site 03
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Arkansas
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Hot Springs, Arkansas, United States, 71913
- Valeant Site 02
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California
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Fremont, California, United States, 94538
- Valeant Site 07
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Sacramento, California, United States, 95819
- Valeant Site 08
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Colorado
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Denver, Colorado, United States, 80220
- Valeant Site 09
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Florida
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Boynton Beach, Florida, United States, 33437
- Valeant Site 11
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North Miami Beach, Florida, United States, 33162
- Valeant Site 13
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Sanford, Florida, United States, 32771
- Valeant Site 12
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West Palm Beach, Florida, United States, 33401
- Valeant Site 10
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Georgia
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Marietta, Georgia, United States, 30060
- Valeant Site 15
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Snellville, Georgia, United States, 30078
- Valeant Site 14
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Idaho
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Boise, Idaho, United States, 83704
- Valeant Site 16
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Kansas
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Overland Park, Kansas, United States, 66215
- Valeant Site 17
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Kentucky
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Louisville, Kentucky, United States, 40217
- Valeant Site 18
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Louisville, Kentucky, United States, 40241
- Valeant Site 19
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Maryland
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Glenn Dale, Maryland, United States, 20769
- Valeant Site 21
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Massachusetts
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Needham, Massachusetts, United States, 02492
- Valeant Site 20
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Michigan
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Detroit, Michigan, United States, 48202
- Valeant Site 22
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New Jersey
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Morristown, New Jersey, United States, 07960
- Valeant Site 24
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New Mexico
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Albuquerque, New Mexico, United States, 87106
- Valeant Site 25
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New York
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New York, New York, United States, 10022
- Valeant Site 27
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New York, New York, United States, 10075
- Valeant Site 26
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North Carolina
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High Point, North Carolina, United States, 27262
- Valeant Site 23
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Oregon
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Gresham, Oregon, United States, 97030
- Valeant Site 28
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Rhode Island
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Johnston, Rhode Island, United States, 02919
- Valeant Site 30
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Tennessee
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Nashville, Tennessee, United States, 37215
- Valeant Site 31
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Texas
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Austin, Texas, United States, 78759
- Valeant Site 32
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Pflugerville, Texas, United States, 78660
- Valeant Site 33
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San Antonio, Texas, United States, 78213
- Valeant Site 34
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Virginia
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Norfolk, Virginia, United States, 23502
- 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 an EGSS of 3 (moderate) or 4 (severe) at the baseline visit.
- Subjects with a facial acne inflammatory lesion (papules, pustules, and nodules) count no less than 20, but no more than 100.
- Subjects with a facial acne non-inflammatory lesion (open and closed comedones) count no less than 30, but no more than 150.
- Subjects with 2 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 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 |
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Experimental: IDP-126 Gel
Gel
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Gel
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Active Comparator: IDP-126 Component A
Component A
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Component A
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Active Comparator: IDP-126 Component B
Component B
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Component B
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Active Comparator: IDP-126 Component C
Component C
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Component C
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Placebo Comparator: IDP-126 Vehicle Gel
Vehicle Gel
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Vehicle Gel
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Inflammatory Lesion Counts
Time Frame: Baseline to Week 12
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Absolute change from Baseline to Week 12 in mean inflammatory lesion counts
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Baseline to Week 12
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Non-inflammatory Lesion Counts
Time Frame: Baseline to Week 12
|
Absolute change from Baseline to Week 12 in mean non-inflammatory lesion counts
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Baseline to Week 12
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Percentage of Participants With Success on the Evaluator's Global Severity Score
Time Frame: Baseline to Week 12
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Success was defined as at least a two grade reduction and clear or almost clear at Week 12.
The Evaluator's Global Severity Score has grades for acne severity of 0 (Clear), 1 (Almost Clear), 2 (Mild), 3 (Moderate), and 4 (Severe), with higher scores indicating worse severity.
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Baseline to Week 12
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Inflammatory Lesion Count Changes at Week 2, 4, and 8
Time Frame: Baseline to Week 2, 4, 8
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Absolute change from Baseline to Week 2, 4, and 8 in mean inflammatory lesion counts
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Baseline to Week 2, 4, 8
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Non-inflammatory Lesion Count Changes at Week 2, 4, and 8
Time Frame: Baseline to Week 2, 4, 8
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Absolute change from Baseline to Week 2, 4, and 8 in mean non-inflammatory lesion counts
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Baseline to Week 2, 4, 8
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Inflammatory Lesion Count Percentage Changes at Week 2, 4, and 8
Time Frame: Baseline to Week 2, 4, 8
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Percentage change from Baseline to Week 2, 4, and 8 in mean inflammatory lesion counts
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Baseline to Week 2, 4, 8
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Non-inflammatory Lesion Count Percentage Changes at Week 2, 4, and 8
Time Frame: Baseline to Week 2, 4, 8
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Percentage change from Baseline to Week 2, 4, and 8 in mean non-inflammatory lesion counts
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Baseline to Week 2, 4, 8
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Percentage of Participants With Success on the Evaluator's Global Severity Score at Weeks 2, 4, and 8
Time Frame: Baseline to Week 2, 4, and 8
|
Success was defined as at least a two grade reduction and clear or almost clear at the visit.
The Evaluator's Global Severity Score has grades for acne severity of 0 (Clear), 1 (Almost Clear), 2 (Mild), 3 (Moderate), and 4 (Severe), with higher scores indicating worse severity.
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Baseline to Week 2, 4, and 8
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Percentage of Participants With Two Grade Success on the Evaluator's Global Severity Score - at Weeks 2, 4, and 8
Time Frame: Baseline to Week 2, 4, and 8
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Two grade success was defined as at least a two grade reduction.
The Evaluator's Global Severity Score has grades for acne severity of 0 (Clear), 1 (Almost Clear), 2 (Mild), 3 (Moderate), and 4 (Severe), with higher scores indicating worse severity.
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Baseline to Week 2, 4, and 8
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
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)
October 5, 2017
Primary Completion (Actual)
April 23, 2019
Study Completion (Actual)
April 23, 2019
Study Registration Dates
First Submitted
May 26, 2017
First Submitted That Met QC Criteria
May 26, 2017
First Posted (Actual)
May 31, 2017
Study Record Updates
Last Update Posted (Actual)
November 10, 2021
Last Update Submitted That Met QC Criteria
October 13, 2021
Last Verified
October 1, 2021
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- V01-126A-201
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Yes
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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Galderma R&DCompletedSevere Acne VulgarisUnited States, Canada, Puerto Rico
-
Sebacia, Inc.CompletedInflammatory Acne VulgarisUnited States
-
Nexgen Dermatologics, Inc.Unknown
-
Rejuva Medical AestheticsHealMD, LLCNot yet recruitingAcne Vulgaris (Disorder)United States
-
InMode MD Ltd.Active, not recruitingInflammatory Acne VulgarisUnited States
-
PollogenLumenis Be Ltd.RecruitingModerate to Severe Acne VulgarisUnited States
-
Boston PharmaceuticalsCompletedModerate to Severe Acne VulgarisUnited States, Canada
-
Bispebjerg HospitalCompleted
-
Actavis Mid-Atlantic LLCCompletedMILD TO SEVERE ACNE VULGARISIndia
-
Assiut UniversityCompleted
Clinical Trials on IDP-126 Gel
-
Bausch Health Americas, Inc.CompletedAcne VulgarisUnited States, Canada
-
Bausch Health Americas, Inc.CompletedAcne VulgarisUnited States, Canada
-
Bausch Health Americas, Inc.Completed
-
Bausch Health Americas, Inc.CompletedAcne VulgarisUnited States, Belgium, Canada
-
Bausch Health Americas, Inc.CompletedAcne VulgarisUnited States, Canada
-
Bausch Health Americas, Inc.CompletedAcne VulgarisUnited States, Canada
-
Bausch Health Americas, Inc.CompletedAcne VulgarisUnited States, Canada
-
Valeant PharmaceuticalsUnknown
-
Bausch Health Americas, Inc.Completed
-
Dow Pharmaceutical SciencesUnknownPlaque PsoriasisUnited States