Efficacy and Safety of IDP-121 and IDP-121 Vehicle Lotion in the Treatment of Acne Vulgaris

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: Acne
• Intervention / Treatment: Drug: IDP-121 Vehicle Lotion; Drug: IDP 121 Lotion

• Study Type: Interventional
• Enrollment (Actual): 820
• Phase: Phase 3

Contacts and Locations

Study Locations

• United States
  • Arizona
    • Glendale, Arizona, United States, 85308
      • Valeant Site 21
  • Arkansas
    • Rogers, Arkansas, United States, 72758
      • Valeant Site 34
  • California
    • Anaheim, California, United States, 92801
      • Valeant Site 25
    • Beverly Hills, California, United States, 90210
      • Valeant Site 18
    • Fremont, California, United States, 94538
      • Valeant Site 09
    • Murrieta, California, United States, 92526
      • Valeant Site 17
    • Oxnard, California, United States, 93035
      • Valeant Site 26
    • Sacramento, California, United States, 95819
      • Valeant Site 22
    • San Diego, California, United States, 92123
      • Valeant Site 02
    • San Diego, California, United States, 92123
      • Valeant Site 04
    • Santa Monica, California, United States, 90404
      • Valeant Site 19
  • Florida
    • Miami, Florida, United States, 33015
      • Valeant Site 15
    • Miami, Florida, United States, 33144
      • Valeant Site 11
    • Pinellas Park, Florida, United States, 33782
      • Valeant Site 27
    • Sanford, Florida, United States, 32771
      • Valeant Site 31
    • Tampa, Florida, United States, 33624
      • Valeant Site 05
  • Georgia
    • Marietta, Georgia, United States, 30060
      • Valeant Site 28
  • Illinois
    • Buffalo Grove, Illinois, United States, 60089
      • Valeant Site 16
  • Indiana
    • Indianapolis, Indiana, United States, 46256
      • Valeant Site 06
  • Kansas
    • Overland Park, Kansas, United States, 66215
      • Valeant Site 12
  • Louisiana
    • Crowley, Louisiana, United States, 70526
      • Valeant Site 32
  • Michigan
    • Clarkston, Michigan, United States, 48346
      • Valeant Site 30
    • Detroit, Michigan, United States, 48302
      • Valeant Site 03
  • Nevada
    • Henderson, Nevada, United States, 89074
      • Valeant Site 20
  • New York
    • New York, New York, United States, 10016
      • Valeant Site 08
  • North Carolina
    • Winston-Salem, North Carolina, United States, 27104
      • Valeant Site 23
  • Pennsylvania
    • Hazleton, Pennsylvania, United States, 18201
      • Valeant Site 29
  • Rhode Island
    • Johnston, Rhode Island, United States, 02919
      • Valeant Site 24
  • Texas
    • Austin, Texas, United States, 78759
      • Valeant Site 10
    • Houston, Texas, United States, 77065
      • Valeant Site 01
    • Port Arthur, Texas, United States, 77460
      • Valeant Site 33
    • San Antonio, Texas, United States, 78229
      • Valeant Site 07
    • San Antonio, Texas, United States, 78229
      • Valeant Site 13
    • San Antonio, Texas, United States, 78249
      • Valeant Site 14

Participation Criteria

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).
• Participants must be willing to comply with study instructions and return to the study center for required visits. Participants under the age of consent must be accompanied by the parent or legal guardian at the time of assent/consent signing.
• If a cleanser, moisturizer or sunscreen is needed during the study, participants must be willing to use only allowed cleansers, moisturizers, sunscreens, or moisturizer/sunscreen combination products. If the participant wears makeup they must agree to use non-comedogenic makeup.

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, gramnegative 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.
• History of hypersensitivity or allergic reactions to any of the study preparations as described in the Investigator's Brochure, including known sensitivities to any dosage form of tretinoin.
• Participants who are unable to communicate or cooperate with the Investigator due to language problems, poor mental development, or impaired cerebral function.
• Participants with any underlying disease that the Investigator deems uncontrolled, and poses a concern for the participant's safety while participating in the study.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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

Outcome Measure	Measure Description	Time Frame
Absolute Change From Baseline in Mean Noninflammatory Lesion Count to 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	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	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

Outcome Measure	Measure Description	Time Frame
Percent Change From Baseline in Noninflammatory Lesion Count to 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	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

• Sponsor: Bausch Health Americas, Inc.
• Investigators: Study Chair: Tim Theisen, TKL Research, Inc.

Publications and helpful links

General Publications

• Tyring SK, Kircik L, Pariser DM, Woolery-Lloyd HC, Harper JC, Bhatt V, Pillai R, Guenin E. The Effects of Once-Daily Tretinoin 0.05% Lotion on Quality of Life in Patients with Moderate-to-Severe Acne Vulgaris. Am J Clin Dermatol. 2020 Dec;21(6):891-899. doi: 10.1007/s40257-020-00559-3.

Study record dates

Study Major Dates

• Study Start (Actual): November 4, 2015
• Primary Completion (Actual): February 23, 2017
• Study Completion (Actual): February 23, 2017

Study Registration Dates

• First Submitted: October 11, 2016
• First Submitted That Met QC Criteria: November 11, 2016
• First Posted (Estimate): November 16, 2016

Study Record Updates

• Last Update Posted (Actual): December 18, 2019
• 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: Skin Diseases; Acneiform Eruptions; Sebaceous Gland Diseases; Acne Vulgaris
• Other Study ID Numbers: V01-121A-302

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED