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

Primary Purpose

Acne Vulgaris

Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
IDP-123 Lotion
IDP-123 Vehicle Lotion
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 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

Sites / Locations

  • Valeant Site 19
  • Valeant Site 21
  • Valeant Site 24
  • Valeant Site 04
  • Valeant Site 02
  • Valeant Site 42
  • Valeant Site 39
  • Valeant Site 01
  • Valeant Site 37
  • Valeant Site 35
  • Valeant Site 40
  • Valeant Site 33
  • Valeant Site 27
  • Valeant Site 13
  • Valeant Site 03
  • Valeant Site 26
  • Valeant Site 30
  • Valeant Site 06
  • Valeant Site 23
  • Valeant Site 17
  • Valeant Site 31
  • Valeant Site 22
  • Valeant Site 08
  • Valeant Site 38
  • Valeant Site 16
  • Valeant site 20
  • Valeant Site 36
  • Valeant Site 09
  • Valeant Site 32
  • Valeant Site 11
  • valeant Site 07
  • Valeant Site 15
  • Valeant Site 34
  • valeant Site 14
  • Valeant Site 12
  • Valeant Site 05
  • Valeant Site 18
  • Valeant Site 25
  • Valeant Site 43
  • Valeant Site 41
  • Valeant Site 45
  • Valeant Site 44
  • Valeant Site 29
  • Valeant Site 28
  • Valeant Site 10

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

IDP-123 Lotion

IDP-123 Vehicle Lotion

Arm Description

Tazarotene 0.045% Lotion

Vehicle Lotion

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
May 24, 2017
Last Updated
March 30, 2021
Sponsor
Bausch Health Americas, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT03168321
Brief Title
A Phase 3, Vehicle-controlled Efficacy and Safety Study of IDP-123 Lotion in the Treatment of Acne Vulgaris (301)
Official Title
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
Study Type
Interventional

2. Study Status

Record Verification Date
March 2021
Overall Recruitment Status
Completed
Study Start Date
June 29, 2017 (Actual)
Primary Completion Date
June 7, 2018 (Actual)
Study Completion Date
June 7, 2018 (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
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.
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.

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
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
813 (Actual)

8. Arms, Groups, and Interventions

Arm Title
IDP-123 Lotion
Arm Type
Experimental
Arm Description
Tazarotene 0.045% Lotion
Arm Title
IDP-123 Vehicle Lotion
Arm Type
Placebo Comparator
Arm Description
Vehicle Lotion
Intervention Type
Drug
Intervention Name(s)
IDP-123 Lotion
Other Intervention Name(s)
IDP-123
Intervention Description
Tazarotene 0.045% Lotion
Intervention Type
Drug
Intervention Name(s)
IDP-123 Vehicle Lotion
Other Intervention Name(s)
Vehicle
Intervention Description
Vehicle Lotion
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
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 a score of 3 (moderate) or 4 (severe) on the Evaluator's Global Severity 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 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
Valeant Pharmaceuticals
Official's Role
Study Director
Facility Information:
Facility Name
Valeant Site 19
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85032
Country
United States
Facility Name
Valeant Site 21
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85032
Country
United States
Facility Name
Valeant Site 24
City
Hot Springs
State/Province
Arkansas
ZIP/Postal Code
71913
Country
United States
Facility Name
Valeant Site 04
City
La Mesa
State/Province
California
ZIP/Postal Code
91942
Country
United States
Facility Name
Valeant Site 02
City
Manhattan Beach
State/Province
California
ZIP/Postal Code
90266
Country
United States
Facility Name
Valeant Site 42
City
Murrieta
State/Province
California
ZIP/Postal Code
92562
Country
United States
Facility Name
Valeant Site 39
City
Sacramento
State/Province
California
ZIP/Postal Code
95819
Country
United States
Facility Name
Valeant Site 01
City
San Diego
State/Province
California
ZIP/Postal Code
22434
Country
United States
Facility Name
Valeant Site 37
City
Wheat Ridge
State/Province
Colorado
ZIP/Postal Code
80033
Country
United States
Facility Name
Valeant Site 35
City
Boca Raton
State/Province
Florida
ZIP/Postal Code
33486
Country
United States
Facility Name
Valeant Site 40
City
North Miami Beach
State/Province
Florida
ZIP/Postal Code
33162
Country
United States
Facility Name
Valeant Site 33
City
Ormond Beach
State/Province
Florida
ZIP/Postal Code
32174
Country
United States
Facility Name
Valeant Site 27
City
Pembroke Pines
State/Province
Florida
ZIP/Postal Code
33028
Country
United States
Facility Name
Valeant Site 13
City
Sanford
State/Province
Florida
ZIP/Postal Code
32771
Country
United States
Facility Name
Valeant Site 03
City
West Palm Beach
State/Province
Florida
ZIP/Postal Code
33401
Country
United States
Facility Name
Valeant Site 26
City
Newnan
State/Province
Georgia
ZIP/Postal Code
30263
Country
United States
Facility Name
Valeant Site 30
City
Boise
State/Province
Idaho
ZIP/Postal Code
83704
Country
United States
Facility Name
Valeant Site 06
City
Arlington Heights
State/Province
Illinois
ZIP/Postal Code
60005
Country
United States
Facility Name
Valeant Site 23
City
New Albany
State/Province
Indiana
ZIP/Postal Code
47150
Country
United States
Facility Name
Valeant Site 17
City
South Bend
State/Province
Indiana
ZIP/Postal Code
46617
Country
United States
Facility Name
Valeant Site 31
City
Overland Park
State/Province
Kansas
ZIP/Postal Code
66215
Country
United States
Facility Name
Valeant Site 22
City
Louisville
State/Province
Kentucky
ZIP/Postal Code
40217
Country
United States
Facility Name
Valeant Site 08
City
Metairie
State/Province
Louisiana
ZIP/Postal Code
70006
Country
United States
Facility Name
Valeant Site 38
City
Detroit
State/Province
Michigan
ZIP/Postal Code
48202
Country
United States
Facility Name
Valeant Site 16
City
Warren
State/Province
Michigan
ZIP/Postal Code
48088
Country
United States
Facility Name
Valeant site 20
City
New York
State/Province
New York
ZIP/Postal Code
10022
Country
United States
Facility Name
Valeant Site 36
City
New York
State/Province
New York
ZIP/Postal Code
10075
Country
United States
Facility Name
Valeant Site 09
City
High Point
State/Province
North Carolina
ZIP/Postal Code
27262
Country
United States
Facility Name
Valeant Site 32
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45236
Country
United States
Facility Name
Valeant Site 11
City
Dublin
State/Province
Ohio
ZIP/Postal Code
43016
Country
United States
Facility Name
valeant Site 07
City
Gresham
State/Province
Oregon
ZIP/Postal Code
97030
Country
United States
Facility Name
Valeant Site 15
City
Johnston
State/Province
Rhode Island
ZIP/Postal Code
02919
Country
United States
Facility Name
Valeant Site 34
City
Knoxville
State/Province
Tennessee
ZIP/Postal Code
37917
Country
United States
Facility Name
valeant Site 14
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37215
Country
United States
Facility Name
Valeant Site 12
City
Austin
State/Province
Texas
ZIP/Postal Code
78759
Country
United States
Facility Name
Valeant Site 05
City
Katy
State/Province
Texas
ZIP/Postal Code
77494
Country
United States
Facility Name
Valeant Site 18
City
Plano
State/Province
Texas
ZIP/Postal Code
75093
Country
United States
Facility Name
Valeant Site 25
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78213
Country
United States
Facility Name
Valeant Site 43
City
Webster
State/Province
Texas
ZIP/Postal Code
77598
Country
United States
Facility Name
Valeant Site 41
City
Salt Lake City
State/Province
Utah
ZIP/Postal Code
84114
Country
United States
Facility Name
Valeant Site 45
City
Norfolk
State/Province
Virginia
ZIP/Postal Code
23507
Country
United States
Facility Name
Valeant Site 44
City
Spokane
State/Province
Washington
ZIP/Postal Code
99202
Country
United States
Facility Name
Valeant Site 29
City
Peterborough
State/Province
Ontario
ZIP/Postal Code
K9J5K2
Country
Canada
Facility Name
Valeant Site 28
City
Waterloo
State/Province
Ontario
ZIP/Postal Code
N2J1C4
Country
Canada
Facility Name
Valeant Site 10
City
Laval
State/Province
Quebec
ZIP/Postal Code
H7E0E3
Country
Canada

12. IPD Sharing Statement

Plan to Share IPD
Undecided

Learn more about this trial

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

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