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

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.

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.
820

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 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

  • United States
    • Alabama
      • Guntersville, Alabama, United States, 35976
        • Valeant Site 36
    • Arizona
      • Phoenix, Arizona, United States, 85032
        • Valeant Site 14
    • Arkansas
      • Hot Springs, Arkansas, United States, 71913
        • Valeant Site 28
    • California
      • Fountain Valley, California, United States, 92708
        • Valeant Site 38
      • Manhattan Beach, California, United States, 90266
        • Valeant Site 34
      • Oceanside, California, United States, 92056
        • Valeant Site 23
      • Rancho Cucamonga, California, United States, 91730
        • Valeant Site 35
      • San Diego, California, United States, 92123
        • Valeant Site 20
    • Colorado
      • Denver, Colorado, United States, 80220
        • Valeant Site 32
    • Connecticut
      • Shelton, Connecticut, United States, 06484
        • Valeant Site 10
    • Florida
      • Boynton Beach, Florida, United States, 33437
        • Valeant Site 02
      • Coral Gables, Florida, United States, 33146
        • Valeant Site 15
      • Miami, Florida, United States, 33142
        • Valeant Site 37
      • Pembroke Pines, Florida, United States, 33028
        • Valeant Site 39
      • West Palm Beach, Florida, United States, 33401
        • Valeant Site 01
    • Idaho
      • Boise, Idaho, United States, 83704
        • Valeant Site 19
    • Illinois
      • Arlington Heights, Illinois, United States, 60005
        • Valeant Site 04
    • Indiana
      • Carmel, Indiana, United States, 46032
        • Valeant Site 27
      • Plainfield, Indiana, United States, 46168
        • Valeant 12
    • Kentucky
      • Louisville, Kentucky, United States, 40202
        • Valeant Site 09
      • Louisville, Kentucky, United States, 40217
        • Valeant Site 16
    • Massachusetts
      • Needham, Massachusetts, United States, 02492
        • Valeant Site 33
    • Michigan
      • Warren, Michigan, United States, 48088
        • Valeant Site 11
    • Nebraska
      • Omaha, Nebraska, United States, 68114
        • Valeant Site 08
      • Omaha, Nebraska, United States, 68144
        • Valeant Site 25
    • New Jersey
      • Berlin, New Jersey, United States, 08009
        • Valeant Site 13
    • New Mexico
      • Albuquerque, New Mexico, United States, 87106
        • Valeant Site 03
    • New York
      • New York, New York, United States, 10022
        • Valeant Site 26
      • Stony Brook, New York, United States, 11790
        • Valeant Site 31
    • Oregon
      • Gresham, Oregon, United States, 97030
        • Valeant 05
    • Pennsylvania
      • Fort Washington, Pennsylvania, United States, 19034
        • Valeant Site 22
    • South Carolina
      • Charleston, South Carolina, United States, 29414
        • Valeant Site 24
    • Texas
      • Dallas, Texas, United States, 75231
        • Valeant Site 06
      • Houston, Texas, United States, 77004
        • Valeant Site 30
      • Pflugerville, Texas, United States, 78660
        • Valeant Site 17
      • San Antonio, Texas, United States, 78229
        • Valeant Site 07
      • Webster, Texas, United States, 77598
        • Valeant 18
    • Utah
      • Salt Lake City, Utah, United States, 84117
        • Valeant Site 29
    • Virginia
      • Norfolk, Virginia, United States, 23502
        • Valeant Site 21

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 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

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-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.
Drug: IDP-121 Lotion
IDP-121 lotion will be applied as per the instructions provided by the investigational center staff.
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.
Drug: IDP-121 Vehicle Lotion
IDP-121 vehicle lotion will be applied as per the instructions provided by the investigational center staff.

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
Absolute Change From Baseline in Mean Noninflammatory Lesion Count to Week 12
Time Frame: Baseline (Day 0), Week 12
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.
Baseline (Day 0), Week 12
Absolute Change From Baseline in Mean Inflammatory Lesion Count to Week 12
Time Frame: Baseline, Week 12
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.
Baseline, Week 12
Percentage of Participants With Treatment Success at Week 12
Time Frame: Baseline, Week 12
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.
Baseline, 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
Percent Change From Baseline in Noninflammatory Lesion Count to Week 12
Time Frame: Baseline, Week 12
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.
Baseline, Week 12
Percent Change From Baseline in Inflammatory Lesion Count to Week 12
Time Frame: Baseline, Week 12
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.
Baseline, Week 12

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.

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • 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.

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.
November 3, 2015

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.
February 22, 2017

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.
February 22, 2017

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).
October 11, 2016

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.
October 11, 2016

First Posted (Estimate)

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.
October 13, 2016

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.
January 3, 2020

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.
December 16, 2019

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.
December 1, 2019

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.
  • V01-121A-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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