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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
741

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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

  • Canada
    • Manitoba
      • Winnipeg, Manitoba, Canada, R3M 3Z4
        • Valeant Site 01
    • Ontario
      • Barrie, Ontario, Canada, L4M7G1
        • Valeant Site 05
      • Oakville, Ontario, Canada, L6J7W5
        • Valeant Site 06
      • Peterborough, Ontario, Canada, K9J5K2
        • Valeant Site 04
      • Waterloo, Ontario, Canada, N2J1C4
        • Valeant Site 03
  • United States
    • Arkansas
      • Hot Springs, Arkansas, United States, 71913
        • Valeant Site 02
    • California
      • Fremont, California, United States, 94538
        • Valeant Site 07
      • Sacramento, California, United States, 95819
        • Valeant Site 08
    • Colorado
      • Denver, Colorado, United States, 80220
        • Valeant Site 09
    • Florida
      • Boynton Beach, Florida, United States, 33437
        • Valeant Site 11
      • North Miami Beach, Florida, United States, 33162
        • Valeant Site 13
      • Sanford, Florida, United States, 32771
        • Valeant Site 12
      • West Palm Beach, Florida, United States, 33401
        • Valeant Site 10
    • Georgia
      • Marietta, Georgia, United States, 30060
        • Valeant Site 15
      • Snellville, Georgia, United States, 30078
        • Valeant Site 14
    • Idaho
      • Boise, Idaho, United States, 83704
        • Valeant Site 16
    • Kansas
      • Overland Park, Kansas, United States, 66215
        • Valeant Site 17
    • Kentucky
      • Louisville, Kentucky, United States, 40217
        • Valeant Site 18
      • Louisville, Kentucky, United States, 40241
        • Valeant Site 19
    • Maryland
      • Glenn Dale, Maryland, United States, 20769
        • Valeant Site 21
    • Massachusetts
      • Needham, Massachusetts, United States, 02492
        • Valeant Site 20
    • Michigan
      • Detroit, Michigan, United States, 48202
        • Valeant Site 22
    • New Jersey
      • Morristown, New Jersey, United States, 07960
        • Valeant Site 24
    • New Mexico
      • Albuquerque, New Mexico, United States, 87106
        • Valeant Site 25
    • New York
      • New York, New York, United States, 10022
        • Valeant Site 27
      • New York, New York, United States, 10075
        • Valeant Site 26
    • North Carolina
      • High Point, North Carolina, United States, 27262
        • Valeant Site 23
    • Oregon
      • Gresham, Oregon, United States, 97030
        • Valeant Site 28
    • Rhode Island
      • Johnston, Rhode Island, United States, 02919
        • Valeant Site 30
    • Tennessee
      • Nashville, Tennessee, United States, 37215
        • Valeant Site 31
    • Texas
      • Austin, Texas, United States, 78759
        • Valeant Site 32
      • Pflugerville, Texas, United States, 78660
        • Valeant Site 33
      • San Antonio, Texas, United States, 78213
        • Valeant Site 34
    • Virginia
      • Norfolk, Virginia, United States, 23502
        • Valeant Site 35

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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:

  1. Male or female at least 9 years of age and older.
  2. 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).
  3. Subject must have an EGSS of 3 (moderate) or 4 (severe) at the baseline visit.
  4. Subjects with a facial acne inflammatory lesion (papules, pustules, and nodules) count no less than 20, but no more than 100.
  5. Subjects with a facial acne non-inflammatory lesion (open and closed comedones) count no less than 30, but no more than 150.
  6. Subjects with 2 or fewer facial nodules

Exclusion Criteria:

  1. Use of an investigational drug or device within 30 days of enrollment or participation in a research study concurrent with this study.
  2. 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.
  3. 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.
  4. Subjects with a facial beard or mustache that could interfere with the study assessments.
  5. Subjects with more than 2 facial nodules.
  6. 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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: IDP-126 Gel
Gel
Drug: IDP-126 Gel
Gel
Active Comparator: IDP-126 Component A
Component A
Drug: IDP-126 Component A
Component A
Active Comparator: IDP-126 Component B
Component B
Drug: IDP-126 Component B
Component B
Active Comparator: IDP-126 Component C
Component C
Drug: IDP-126 Component C
Component C
Placebo Comparator: IDP-126 Vehicle Gel
Vehicle Gel
Drug: IDP-126 Vehicle Gel
Vehicle Gel

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Inflammatory Lesion Counts
Time Frame: Baseline to Week 12
Absolute change from Baseline to Week 12 in mean inflammatory lesion counts
Baseline to Week 12
Non-inflammatory Lesion Counts
Time Frame: Baseline to Week 12
Absolute change from Baseline to Week 12 in mean non-inflammatory lesion counts
Baseline to Week 12
Percentage of Participants With Success on the Evaluator's Global Severity Score
Time Frame: Baseline to Week 12
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.
Baseline to Week 12

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Inflammatory Lesion Count Changes at Week 2, 4, and 8
Time Frame: Baseline to Week 2, 4, 8
Absolute change from Baseline to Week 2, 4, and 8 in mean inflammatory lesion counts
Baseline to Week 2, 4, 8
Non-inflammatory Lesion Count Changes at Week 2, 4, and 8
Time Frame: Baseline to Week 2, 4, 8
Absolute change from Baseline to Week 2, 4, and 8 in mean non-inflammatory lesion counts
Baseline to Week 2, 4, 8
Inflammatory Lesion Count Percentage Changes at Week 2, 4, and 8
Time Frame: Baseline to Week 2, 4, 8
Percentage change from Baseline to Week 2, 4, and 8 in mean inflammatory lesion counts
Baseline to Week 2, 4, 8
Non-inflammatory Lesion Count Percentage Changes at Week 2, 4, and 8
Time Frame: Baseline to Week 2, 4, 8
Percentage change from Baseline to Week 2, 4, and 8 in mean non-inflammatory lesion counts
Baseline to Week 2, 4, 8
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.
Baseline to Week 2, 4, and 8
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
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.
Baseline to Week 2, 4, and 8

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Bausch Health Americas, 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.

General Publications

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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
October 5, 2017

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
April 23, 2019

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
April 23, 2019

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
May 26, 2017

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 26, 2017

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
May 31, 2017

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
November 10, 2021

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 13, 2021

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
October 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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.

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Locations

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