A Phase 3, Vehicle-controlled Efficacy and Safety Study of IDP-123 Lotion in the Treatment of Acne Vulgaris (301)

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 multicenter, 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: Acne Vulgaris
• Intervention / Treatment: Drug: IDP-123 Lotion; Drug: IDP-123 Vehicle Lotion

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): 813
• Phase: Phase 3

Contacts and Locations

Study Locations

• Canada
  • Ontario
    • Peterborough, Ontario, Canada, K9J5K2
      • Valeant Site 29
    • Waterloo, Ontario, Canada, N2J1C4
      • Valeant Site 28
  • Quebec
    • Laval, Quebec, Canada, H7E0E3
      • Valeant Site 10
• United States
  • Arizona
    • Phoenix, Arizona, United States, 85032
      • Valeant Site 19
    • Phoenix, Arizona, United States, 85032
      • Valeant Site 21
  • Arkansas
    • Hot Springs, Arkansas, United States, 71913
      • Valeant Site 24
  • California
    • La Mesa, California, United States, 91942
      • Valeant Site 04
    • Manhattan Beach, California, United States, 90266
      • Valeant Site 02
    • Murrieta, California, United States, 92562
      • Valeant Site 42
    • Sacramento, California, United States, 95819
      • Valeant Site 39
    • San Diego, California, United States, 22434
      • Valeant Site 01
  • Colorado
    • Wheat Ridge, Colorado, United States, 80033
      • Valeant Site 37
  • Florida
    • Boca Raton, Florida, United States, 33486
      • Valeant Site 35
    • North Miami Beach, Florida, United States, 33162
      • Valeant Site 40
    • Ormond Beach, Florida, United States, 32174
      • Valeant Site 33
    • Pembroke Pines, Florida, United States, 33028
      • Valeant Site 27
    • Sanford, Florida, United States, 32771
      • Valeant Site 13
    • West Palm Beach, Florida, United States, 33401
      • Valeant Site 03
  • Georgia
    • Newnan, Georgia, United States, 30263
      • Valeant Site 26
  • Idaho
    • Boise, Idaho, United States, 83704
      • Valeant Site 30
  • Illinois
    • Arlington Heights, Illinois, United States, 60005
      • Valeant Site 06
  • Indiana
    • New Albany, Indiana, United States, 47150
      • Valeant Site 23
    • South Bend, Indiana, United States, 46617
      • Valeant Site 17
  • Kansas
    • Overland Park, Kansas, United States, 66215
      • Valeant Site 31
  • Kentucky
    • Louisville, Kentucky, United States, 40217
      • Valeant Site 22
  • Louisiana
    • Metairie, Louisiana, United States, 70006
      • Valeant Site 08
  • Michigan
    • Detroit, Michigan, United States, 48202
      • Valeant Site 38
    • Warren, Michigan, United States, 48088
      • Valeant Site 16
  • New York
    • New York, New York, United States, 10022
      • Valeant Site 20
    • New York, New York, United States, 10075
      • Valeant Site 36
  • North Carolina
    • High Point, North Carolina, United States, 27262
      • Valeant Site 09
  • Ohio
    • Cincinnati, Ohio, United States, 45236
      • Valeant Site 32
    • Dublin, Ohio, United States, 43016
      • Valeant Site 11
  • Oregon
    • Gresham, Oregon, United States, 97030
      • Valeant Site 07
  • Rhode Island
    • Johnston, Rhode Island, United States, 02919
      • Valeant Site 15
  • Tennessee
    • Knoxville, Tennessee, United States, 37917
      • Valeant Site 34
    • Nashville, Tennessee, United States, 37215
      • Valeant Site 14
  • Texas
    • Austin, Texas, United States, 78759
      • Valeant Site 12
    • Katy, Texas, United States, 77494
      • Valeant Site 05
    • Plano, Texas, United States, 75093
      • Valeant Site 18
    • San Antonio, Texas, United States, 78213
      • Valeant Site 25
    • Webster, Texas, United States, 77598
      • Valeant Site 43
  • Utah
    • Salt Lake City, Utah, United States, 84114
      • Valeant Site 41
  • Virginia
    • Norfolk, Virginia, United States, 23507
      • Valeant Site 45
  • Washington
    • Spokane, Washington, United States, 99202
      • Valeant Site 44

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 9 years to 99 years (ADULT, OLDER_ADULT, CHILD)
• 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 a score of 3 (moderate) or 4 (severe) on the Evaluator's Global Severity assessment at the baseline visit;
4. Subjects with facial acne inflammatory lesion (papules, pustules, and nodules) count no less than 20 but no more than 50;
5. Subjects with facial acne non-inflammatory lesion (open and closed comedones) count no less than 25 but no more than 100;
6. Subjects with two or fewer 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 two (2) facial nodules;
6. Evidence or history of cosmetic-related acne

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: TRIPLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: IDP-123 Lotion; Tazarotene 0.045% Lotion	Drug: IDP-123 Lotion; Tazarotene 0.045% Lotion; Other Names: IDP-123
PLACEBO_COMPARATOR: IDP-123 Vehicle Lotion; Vehicle Lotion	Drug: IDP-123 Vehicle Lotion; Vehicle Lotion; Other Names: Vehicle

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Absolute Change in Mean Lesion Counts at 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) and Had an EGSS at Week 12 That Equated to "Clear" or "Almost Clear"	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	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)	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	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	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

• Sponsor: Bausch Health Americas, Inc.

Study record dates

Study Major Dates

• Study Start (ACTUAL): June 29, 2017
• Primary Completion (ACTUAL): June 7, 2018
• Study Completion (ACTUAL): June 7, 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: Skin Diseases; Acneiform Eruptions; Sebaceous Gland Diseases; Acne Vulgaris
• Other Study ID Numbers: V01-123A-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