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A Phase 3, Vehicle-controlled Efficacy and Safety Study of IDP-123 Lotion in the Treatment of Acne Vulgaris (302)

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

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
NCT03168334
Brief Title
A Phase 3, Vehicle-controlled Efficacy and Safety Study of IDP-123 Lotion in the Treatment of Acne Vulgaris (302)
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
July 11, 2017 (Actual)
Primary Completion Date
July 24, 2018 (Actual)
Study Completion Date
July 24, 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 multi-center, 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
801 (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 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
Valeant Pharmaceuticals
Official's Role
Study Director
Facility Information:
Facility Name
Valeant Site 41
City
Mobile
State/Province
Alabama
ZIP/Postal Code
36608
Country
United States
Facility Name
Valeant Site 22
City
Rogers
State/Province
Arkansas
ZIP/Postal Code
72758
Country
United States
Facility Name
Valeant Site 34
City
Carlsbad
State/Province
California
ZIP/Postal Code
92008
Country
United States
Facility Name
Valeant Site 12
City
Fremont
State/Province
California
ZIP/Postal Code
94538
Country
United States
Facility Name
Valeant Site 06
City
San Diego
State/Province
California
ZIP/Postal Code
92123
Country
United States
Facility Name
Valeant Site 13
City
San Diego
State/Province
California
ZIP/Postal Code
92123
Country
United States
Facility Name
Valeant Site 31
City
San Diego
State/Province
California
ZIP/Postal Code
92123
Country
United States
Facility Name
Valeant Site 36
City
Santa Ana
State/Province
California
ZIP/Postal Code
92701
Country
United States
Facility Name
Valeant Site 25
City
Denver
State/Province
Colorado
ZIP/Postal Code
80220
Country
United States
Facility Name
Valeant Site 05
City
Boynton Beach
State/Province
Florida
ZIP/Postal Code
33437
Country
United States
Facility Name
Valeant Site 29
City
Clearwater
State/Province
Florida
ZIP/Postal Code
33761
Country
United States
Facility Name
Valeant Site 38
City
Jupiter
State/Province
Florida
ZIP/Postal Code
33458
Country
United States
Facility Name
Valeant Site 02
City
Miami
State/Province
Florida
ZIP/Postal Code
33144
Country
United States
Facility Name
Valeant Site 26
City
West Palm Beach
State/Province
Florida
ZIP/Postal Code
33406
Country
United States
Facility Name
Valeant Site 44
City
Snellville
State/Province
Georgia
ZIP/Postal Code
30078
Country
United States
Facility Name
Valeant Site 32
City
Louisville
State/Province
Kentucky
ZIP/Postal Code
40241
Country
United States
Facility Name
Valeant Site 19
City
Rockville
State/Province
Maryland
ZIP/Postal Code
20850
Country
United States
Facility Name
Valeant Site 08
City
Bay City
State/Province
Michigan
ZIP/Postal Code
48706
Country
United States
Facility Name
Valeant Site 30
City
Clarkston
State/Province
Michigan
ZIP/Postal Code
48346
Country
United States
Facility Name
Valeant Site 37
City
Clinton Township
State/Province
Michigan
ZIP/Postal Code
48038
Country
United States
Facility Name
Valeant Site 20
City
Fort Gratiot
State/Province
Michigan
ZIP/Postal Code
48059
Country
United States
Facility Name
Valeant Site 24
City
Fridley
State/Province
Minnesota
ZIP/Postal Code
55432
Country
United States
Facility Name
Valeant Site 03
City
Morristown
State/Province
New Jersey
ZIP/Postal Code
07960
Country
United States
Facility Name
Valeant Site 42
City
Albuquerque
State/Province
New Mexico
ZIP/Postal Code
87106
Country
United States
Facility Name
Valeant Site 10
City
New York
State/Province
New York
ZIP/Postal Code
10155
Country
United States
Facility Name
Valeant Site 43
City
Rochester
State/Province
New York
ZIP/Postal Code
14623
Country
United States
Facility Name
Valeant Site 33
City
Stony Brook
State/Province
New York
ZIP/Postal Code
11790
Country
United States
Facility Name
Valeant Site 11
City
Oklahoma City
State/Province
Oklahoma
ZIP/Postal Code
73112
Country
United States
Facility Name
Valeant Site 28
City
Broomall
State/Province
Pennsylvania
ZIP/Postal Code
19008
Country
United States
Facility Name
Valeant Site 16
City
Warwick
State/Province
Rhode Island
ZIP/Postal Code
02886
Country
United States
Facility Name
Valeant Site 18
City
Knoxville
State/Province
Tennessee
ZIP/Postal Code
37922
Country
United States
Facility Name
Valeant Site 14
City
Murfreesboro
State/Province
Tennessee
ZIP/Postal Code
37130
Country
United States
Facility Name
Valeant Site 23
City
College Station
State/Province
Texas
ZIP/Postal Code
77845
Country
United States
Facility Name
Valeant Site 07
City
Dallas
State/Province
Texas
ZIP/Postal Code
75234
Country
United States
Facility Name
Valeant Site 27
City
Pflugerville
State/Province
Texas
ZIP/Postal Code
78660
Country
United States
Facility Name
Valeant Site 04
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78218
Country
United States
Facility Name
Valeant Site 39
City
Sugar Land
State/Province
Texas
ZIP/Postal Code
77479
Country
United States
Facility Name
Valeant Site 09
City
Layton
State/Province
Utah
ZIP/Postal Code
84041
Country
United States
Facility Name
Valeant Site 15
City
West Jordan
State/Province
Utah
ZIP/Postal Code
84088
Country
United States
Facility Name
Valeant Site 21
City
Charlottesville
State/Province
Virginia
ZIP/Postal Code
22911
Country
United States
Facility Name
Valeant Site 35
City
Walla Walla
State/Province
Washington
ZIP/Postal Code
99362
Country
United States
Facility Name
Valeant Site 01
City
Surrey
State/Province
British Columbia
ZIP/Postal Code
V3VOC6
Country
Canada
Facility Name
Valeant Site 45
City
Winnipeg
State/Province
Manitoba
ZIP/Postal Code
R3M3Z4
Country
Canada
Facility Name
Valeant Site 40
City
Windsor
State/Province
Ontario
ZIP/Postal Code
N8W5L7
Country
Canada
Facility Name
Valeant Site 17
City
Saint-Jérôme
State/Province
Quebec
ZIP/Postal Code
J7Z3B8
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 (302)

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