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Study Comparing the Safety and Efficacy of IDP-120 Gel and IDP-120 Vehicle Gel in the Treatment of Acne Vulgaris

Primary Purpose

Acne Vulgaris

Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
IDP-120 Gel
IDP-120 Vehicle Gel
Sponsored by
Bausch Health Americas, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Acne Vulgaris

Eligibility Criteria

9 Years - undefined (Child, Adult, Older Adult)All SexesAccepts Healthy Volunteers

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 Score (EGSS) 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 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 two (2) facial nodules;
  6. Evidence or history of cosmetic-related acne

Sites / Locations

  • Valeant Site 210
  • Valeant Site 201
  • Valeant Site 206
  • Valeant Site 218
  • Valeant Site 204
  • Valeant Site 217
  • Valeant Site 202S
  • Valeant Site 214
  • Valeant Site 222
  • Valeant Site 215
  • Valeant Site 205
  • Valeant Site 216
  • Valeant Site 221
  • Valeant Site 227
  • Valeant Site 229
  • Valeant Site 230
  • Valeant Site 213
  • Valeant Site 223
  • Valeant Site 219
  • Valeant Site 228

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

IDP-120 Gel

IDP-120 vehicle gel

Arm Description

IDP-120 Gel, once-daily application

IDP-120 vehicle gel, once daily application

Outcomes

Primary Outcome Measures

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.
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.

Secondary Outcome Measures

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.
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.
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.
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.

Full Information

First Posted
September 6, 2018
Last Updated
March 3, 2023
Sponsor
Bausch Health Americas, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT03664752
Brief Title
Study Comparing the Safety and Efficacy of IDP-120 Gel and IDP-120 Vehicle Gel in the Treatment of Acne Vulgaris
Official Title
A Phase 3, Multi-Center, Randomized, Double-Blind, Vehicle-Controlled, 2 Arm, Parallel Group Study Comparing the Safety and Efficacy of IDP-120 Gel and IDP-120 Vehicle Gel in the Treatment of Acne Vulgaris
Study Type
Interventional

2. Study Status

Record Verification Date
March 2023
Overall Recruitment Status
Completed
Study Start Date
December 10, 2018 (Actual)
Primary Completion Date
May 7, 2020 (Actual)
Study Completion Date
May 7, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Bausch Health Americas, Inc.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
study designed to assess the safety, tolerability, and efficacy of IDP-120 Gel and IDP-120 Vehicle Gel
Detailed Description
This is a multi-center, randomized, double-blind, vehicle-controlled, 12-week study designed to assess the safety, tolerability, and efficacy of IDP-120 Gel and IDP-120 Vehicle Gel at Weeks 2, 4, 8, and 12. 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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acne Vulgaris

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Model Description
Multi-Center, Randomized, Double-Blind, Vehicle-Controlled, 2 Arm, Parallel Group Study
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Masking Description
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor) As a double-blinded study, the investigators, the site staff, the sponsor, and the clinical monitors will not be aware of the treatment assigned to the individual study subjects
Allocation
Randomized
Enrollment
585 (Actual)

8. Arms, Groups, and Interventions

Arm Title
IDP-120 Gel
Arm Type
Experimental
Arm Description
IDP-120 Gel, once-daily application
Arm Title
IDP-120 vehicle gel
Arm Type
Placebo Comparator
Arm Description
IDP-120 vehicle gel, once daily application
Intervention Type
Drug
Intervention Name(s)
IDP-120 Gel
Intervention Description
IDP-120 Gel, once-daily application
Intervention Type
Drug
Intervention Name(s)
IDP-120 Vehicle Gel
Intervention Description
IDP-120 Vehicle Gel, once-daily application
Primary Outcome Measure Information:
Title
Absolute Change in Mean Lesion Counts at Week 12
Description
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.
Time Frame
Baseline to Week 12
Title
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"
Description
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.
Time Frame
Baseline to Week 12
Secondary Outcome Measure Information:
Title
Percentage Change in Mean Lesion Counts at Week 12
Description
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.
Time Frame
Baseline to Week 12
Title
Percentage of Subjects Who Had at Least a 2-grade Reduction From Baseline at Week 12 in the Evaluator's Global Severity Score (EGSS)
Description
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.
Time Frame
Baseline to Week 12
Title
Percentage Change in Mean Lesion Counts at Week 8
Description
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.
Time Frame
Baseline to Week 8
Title
Percentage Change in Mean Lesion Counts at Week 4
Description
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.
Time Frame
Baseline to Week 4

10. Eligibility

Sex
All
Minimum Age & Unit of Time
9 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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 a score of 3 (moderate) or 4 (severe) on the Evaluator's Global Severity Score (EGSS) assessment at the baseline visit; Subjects with facial acne inflammatory lesion (papules, pustules, and nodules) count no less than 20 but no more than 50; Subjects with facial acne non-inflammatory lesion (open and closed comedones) count no less than 25 but no more than 100; Subjects with two 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 two (2) facial nodules; Evidence or history of cosmetic-related acne
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Anya Loncaric
Organizational Affiliation
Bausch Health Companies
Official's Role
Study Director
Facility Information:
Facility Name
Valeant Site 210
City
Rogers
State/Province
Arkansas
ZIP/Postal Code
72758
Country
United States
Facility Name
Valeant Site 201
City
Manhattan Beach
State/Province
California
ZIP/Postal Code
90266
Country
United States
Facility Name
Valeant Site 206
City
San Diego
State/Province
California
ZIP/Postal Code
92123
Country
United States
Facility Name
Valeant Site 218
City
San Diego
State/Province
California
ZIP/Postal Code
92123
Country
United States
Facility Name
Valeant Site 204
City
Boynton Beach
State/Province
Florida
ZIP/Postal Code
33437
Country
United States
Facility Name
Valeant Site 217
City
Brandon
State/Province
Florida
ZIP/Postal Code
33511
Country
United States
Facility Name
Valeant Site 202S
City
Miami
State/Province
Florida
ZIP/Postal Code
33144
Country
United States
Facility Name
Valeant Site 214
City
Tampa
State/Province
Florida
ZIP/Postal Code
33606
Country
United States
Facility Name
Valeant Site 222
City
Snellville
State/Province
Georgia
ZIP/Postal Code
30078
Country
United States
Facility Name
Valeant Site 215
City
Boise
State/Province
Idaho
ZIP/Postal Code
83704
Country
United States
Facility Name
Valeant Site 205
City
Metairie
State/Province
Louisiana
ZIP/Postal Code
70006
Country
United States
Facility Name
Valeant Site 216
City
Clarkston
State/Province
Michigan
ZIP/Postal Code
48346
Country
United States
Facility Name
Valeant Site 221
City
Clinton Township
State/Province
Michigan
ZIP/Postal Code
48038
Country
United States
Facility Name
Valeant Site 227
City
Rochester
State/Province
New York
ZIP/Postal Code
14623
Country
United States
Facility Name
Valeant Site 229
City
Raleigh
State/Province
North Carolina
ZIP/Postal Code
27612
Country
United States
Facility Name
Valeant Site 230
City
Raleigh
State/Province
North Carolina
ZIP/Postal Code
27612
Country
United States
Facility Name
Valeant Site 213
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78213
Country
United States
Facility Name
Valeant Site 223
City
Spokane
State/Province
Washington
ZIP/Postal Code
99202
Country
United States
Facility Name
Valeant Site 219
City
Waterloo
State/Province
Ontario
ZIP/Postal Code
N2J 1C4
Country
Canada
Facility Name
Valeant Site 228
City
Waterloo
State/Province
Ontario
ZIP/Postal Code
N2J 1C4
Country
Canada

12. IPD Sharing Statement

Plan to Share IPD
Undecided

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Study Comparing the Safety and Efficacy of IDP-120 Gel and IDP-120 Vehicle Gel in the Treatment of Acne Vulgaris

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