search
Back to results

A Phase 2, Multicenter, Randomized, Double-Blind, Vehicle Controlled, Parallel-Group, Clinical Study in the Treatment of Acne Vulgaris

Primary Purpose

Acne Vulgaris

Status
Completed
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
IDP-126 Gel
IDP-126 Component A
IDP-126 Component B
IDP-126 Component C
IDP-126 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 - 99 Years (Child, Adult, Older Adult)All SexesDoes not accept 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 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.

Sites / Locations

  • Valeant Site 02
  • Valeant Site 07
  • Valeant Site 08
  • Valeant Site 09
  • Valeant Site 11
  • Valeant Site 13
  • Valeant Site 12
  • Valeant Site 10
  • Valeant Site 15
  • Valeant Site 14
  • Valeant Site 16
  • Valeant Site 17
  • Valeant Site 18
  • Valeant Site 19
  • valeant Site 21
  • Valeant Site 20
  • Valeant Site 22
  • Valeant Site 24
  • Valeant Site 25
  • Valeant Site 27
  • Valeant Site 26
  • Valeant Site 23
  • Valeant Site 28
  • Valeant Site 30
  • Valeant Site 31
  • Valeant Site 32
  • Valeant Site 33
  • valeant Site 34
  • Valeant Site 35
  • Valeant Site 01
  • Valeant Site 05
  • Valeant Site 06
  • Valeant Site 04
  • Valeant Site 03

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm Type

Experimental

Active Comparator

Active Comparator

Active Comparator

Placebo Comparator

Arm Label

IDP-126 Gel

IDP-126 Component A

IDP-126 Component B

IDP-126 Component C

IDP-126 Vehicle Gel

Arm Description

Gel

Component A

Component B

Component C

Vehicle Gel

Outcomes

Primary Outcome Measures

Inflammatory Lesion Counts
Absolute change from Baseline to Week 12 in mean inflammatory lesion counts
Non-inflammatory Lesion Counts
Absolute change from Baseline to Week 12 in mean non-inflammatory lesion counts
Percentage of Participants With Success on the Evaluator's Global Severity Score
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.

Secondary Outcome Measures

Inflammatory Lesion Count Changes at Week 2, 4, and 8
Absolute change from Baseline to Week 2, 4, and 8 in mean inflammatory lesion counts
Non-inflammatory Lesion Count Changes at Week 2, 4, and 8
Absolute change from Baseline to Week 2, 4, and 8 in mean non-inflammatory lesion counts
Inflammatory Lesion Count Percentage Changes at Week 2, 4, and 8
Percentage change from Baseline to Week 2, 4, and 8 in mean inflammatory lesion counts
Non-inflammatory Lesion Count Percentage Changes at Week 2, 4, and 8
Percentage change from Baseline to Week 2, 4, and 8 in mean non-inflammatory lesion counts
Percentage of Participants With Success on the Evaluator's Global Severity Score at Weeks 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.
Percentage of Participants With Two Grade Success on the Evaluator's Global Severity Score - at Weeks 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.

Full Information

First Posted
May 26, 2017
Last Updated
October 13, 2021
Sponsor
Bausch Health Americas, Inc.
search

1. Study Identification

Unique Protocol Identification Number
NCT03170388
Brief Title
A Phase 2, Multicenter, Randomized, Double-Blind, Vehicle Controlled, Parallel-Group, Clinical Study in the Treatment of Acne Vulgaris
Official Title
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
Interventional

2. Study Status

Record Verification Date
October 2021
Overall Recruitment Status
Completed
Study Start Date
October 5, 2017 (Actual)
Primary Completion Date
April 23, 2019 (Actual)
Study Completion Date
April 23, 2019 (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
Yes

5. Study Description

Brief Summary
A Phase 2, Multicenter, Randomized, Double-Blind, Vehicle Controlled, Parallel-Group, Clinical Study in the Treatment of Acne Vulgaris
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

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 2
Interventional Study Model
Parallel Assignment
Model Description
Multicenter, Randomized, Double-Blind, Vehicle Controlled, Parallel-Group
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
741 (Actual)

8. Arms, Groups, and Interventions

Arm Title
IDP-126 Gel
Arm Type
Experimental
Arm Description
Gel
Arm Title
IDP-126 Component A
Arm Type
Active Comparator
Arm Description
Component A
Arm Title
IDP-126 Component B
Arm Type
Active Comparator
Arm Description
Component B
Arm Title
IDP-126 Component C
Arm Type
Active Comparator
Arm Description
Component C
Arm Title
IDP-126 Vehicle Gel
Arm Type
Placebo Comparator
Arm Description
Vehicle Gel
Intervention Type
Drug
Intervention Name(s)
IDP-126 Gel
Intervention Description
Gel
Intervention Type
Drug
Intervention Name(s)
IDP-126 Component A
Intervention Description
Component A
Intervention Type
Drug
Intervention Name(s)
IDP-126 Component B
Intervention Description
Component B
Intervention Type
Drug
Intervention Name(s)
IDP-126 Component C
Intervention Description
Component C
Intervention Type
Drug
Intervention Name(s)
IDP-126 Vehicle Gel
Intervention Description
Vehicle Gel
Primary Outcome Measure Information:
Title
Inflammatory Lesion Counts
Description
Absolute change from Baseline to Week 12 in mean inflammatory lesion counts
Time Frame
Baseline to Week 12
Title
Non-inflammatory Lesion Counts
Description
Absolute change from Baseline to Week 12 in mean non-inflammatory lesion counts
Time Frame
Baseline to Week 12
Title
Percentage of Participants With Success on the Evaluator's Global Severity Score
Description
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.
Time Frame
Baseline to Week 12
Secondary Outcome Measure Information:
Title
Inflammatory Lesion Count Changes at Week 2, 4, and 8
Description
Absolute change from Baseline to Week 2, 4, and 8 in mean inflammatory lesion counts
Time Frame
Baseline to Week 2, 4, 8
Title
Non-inflammatory Lesion Count Changes at Week 2, 4, and 8
Description
Absolute change from Baseline to Week 2, 4, and 8 in mean non-inflammatory lesion counts
Time Frame
Baseline to Week 2, 4, 8
Title
Inflammatory Lesion Count Percentage Changes at Week 2, 4, and 8
Description
Percentage change from Baseline to Week 2, 4, and 8 in mean inflammatory lesion counts
Time Frame
Baseline to Week 2, 4, 8
Title
Non-inflammatory Lesion Count Percentage Changes at Week 2, 4, and 8
Description
Percentage change from Baseline to Week 2, 4, and 8 in mean non-inflammatory lesion counts
Time Frame
Baseline to Week 2, 4, 8
Title
Percentage of Participants With Success on the Evaluator's Global Severity Score at Weeks 2, 4, and 8
Description
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.
Time Frame
Baseline to Week 2, 4, and 8
Title
Percentage of Participants With Two Grade Success on the Evaluator's Global Severity Score - at Weeks 2, 4, and 8
Description
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.
Time Frame
Baseline to Week 2, 4, and 8

10. Eligibility

Sex
All
Minimum Age & Unit of Time
9 Years
Maximum Age & Unit of Time
99 Years
Accepts Healthy Volunteers
No
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 an EGSS of 3 (moderate) or 4 (severe) at the baseline visit. Subjects with a facial acne inflammatory lesion (papules, pustules, and nodules) count no less than 20, but no more than 100. Subjects with a facial acne non-inflammatory lesion (open and closed comedones) count no less than 30, but no more than 150. Subjects with 2 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 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 Americas, Inc.
Official's Role
Study Director
Facility Information:
Facility Name
Valeant Site 02
City
Hot Springs
State/Province
Arkansas
ZIP/Postal Code
71913
Country
United States
Facility Name
Valeant Site 07
City
Fremont
State/Province
California
ZIP/Postal Code
94538
Country
United States
Facility Name
Valeant Site 08
City
Sacramento
State/Province
California
ZIP/Postal Code
95819
Country
United States
Facility Name
Valeant Site 09
City
Denver
State/Province
Colorado
ZIP/Postal Code
80220
Country
United States
Facility Name
Valeant Site 11
City
Boynton Beach
State/Province
Florida
ZIP/Postal Code
33437
Country
United States
Facility Name
Valeant Site 13
City
North Miami Beach
State/Province
Florida
ZIP/Postal Code
33162
Country
United States
Facility Name
Valeant Site 12
City
Sanford
State/Province
Florida
ZIP/Postal Code
32771
Country
United States
Facility Name
Valeant Site 10
City
West Palm Beach
State/Province
Florida
ZIP/Postal Code
33401
Country
United States
Facility Name
Valeant Site 15
City
Marietta
State/Province
Georgia
ZIP/Postal Code
30060
Country
United States
Facility Name
Valeant Site 14
City
Snellville
State/Province
Georgia
ZIP/Postal Code
30078
Country
United States
Facility Name
Valeant Site 16
City
Boise
State/Province
Idaho
ZIP/Postal Code
83704
Country
United States
Facility Name
Valeant Site 17
City
Overland Park
State/Province
Kansas
ZIP/Postal Code
66215
Country
United States
Facility Name
Valeant Site 18
City
Louisville
State/Province
Kentucky
ZIP/Postal Code
40217
Country
United States
Facility Name
Valeant Site 19
City
Louisville
State/Province
Kentucky
ZIP/Postal Code
40241
Country
United States
Facility Name
valeant Site 21
City
Glenn Dale
State/Province
Maryland
ZIP/Postal Code
20769
Country
United States
Facility Name
Valeant Site 20
City
Needham
State/Province
Massachusetts
ZIP/Postal Code
02492
Country
United States
Facility Name
Valeant Site 22
City
Detroit
State/Province
Michigan
ZIP/Postal Code
48202
Country
United States
Facility Name
Valeant Site 24
City
Morristown
State/Province
New Jersey
ZIP/Postal Code
07960
Country
United States
Facility Name
Valeant Site 25
City
Albuquerque
State/Province
New Mexico
ZIP/Postal Code
87106
Country
United States
Facility Name
Valeant Site 27
City
New York
State/Province
New York
ZIP/Postal Code
10022
Country
United States
Facility Name
Valeant Site 26
City
New York
State/Province
New York
ZIP/Postal Code
10075
Country
United States
Facility Name
Valeant Site 23
City
High Point
State/Province
North Carolina
ZIP/Postal Code
27262
Country
United States
Facility Name
Valeant Site 28
City
Gresham
State/Province
Oregon
ZIP/Postal Code
97030
Country
United States
Facility Name
Valeant Site 30
City
Johnston
State/Province
Rhode Island
ZIP/Postal Code
02919
Country
United States
Facility Name
Valeant Site 31
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37215
Country
United States
Facility Name
Valeant Site 32
City
Austin
State/Province
Texas
ZIP/Postal Code
78759
Country
United States
Facility Name
Valeant Site 33
City
Pflugerville
State/Province
Texas
ZIP/Postal Code
78660
Country
United States
Facility Name
valeant Site 34
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78213
Country
United States
Facility Name
Valeant Site 35
City
Norfolk
State/Province
Virginia
ZIP/Postal Code
23502
Country
United States
Facility Name
Valeant Site 01
City
Winnipeg
State/Province
Manitoba
ZIP/Postal Code
R3M 3Z4
Country
Canada
Facility Name
Valeant Site 05
City
Barrie
State/Province
Ontario
ZIP/Postal Code
L4M7G1
Country
Canada
Facility Name
Valeant Site 06
City
Oakville
State/Province
Ontario
ZIP/Postal Code
L6J7W5
Country
Canada
Facility Name
Valeant Site 04
City
Peterborough
State/Province
Ontario
ZIP/Postal Code
K9J5K2
Country
Canada
Facility Name
Valeant Site 03
City
Waterloo
State/Province
Ontario
ZIP/Postal Code
N2J1C4
Country
Canada

12. IPD Sharing Statement

Plan to Share IPD
Yes
Citations:
PubMed Identifier
34674160
Citation
Stein Gold L, Baldwin H, Kircik LH, Weiss JS, Pariser DM, Callender V, Lain E, Gold M, Beer K, Draelos Z, Sadick N, Pillai R, Bhatt V, Tanghetti EA. Efficacy and Safety of a Fixed-Dose Clindamycin Phosphate 1.2%, Benzoyl Peroxide 3.1%, and Adapalene 0.15% Gel for Moderate-to-Severe Acne: A Randomized Phase II Study of the First Triple-Combination Drug. Am J Clin Dermatol. 2022 Jan;23(1):93-104. doi: 10.1007/s40257-021-00650-3. Epub 2021 Oct 21.
Results Reference
derived

Learn more about this trial

A Phase 2, Multicenter, Randomized, Double-Blind, Vehicle Controlled, Parallel-Group, Clinical Study in the Treatment of Acne Vulgaris

We'll reach out to this number within 24 hrs