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Efficacy and Safety of IDP-121 and IDP-121 Vehicle Lotion in the Treatment of Acne Vulgaris

Primary Purpose

Acne

Status
Completed
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
IDP-121 Lotion
IDP-121 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

Eligibility Criteria

9 Years - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

Key Inclusion Criteria:

  • Male or female at least 9 years of age and older.
  • Written and verbal informed consent must be obtained. Participants 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 participant reaches age of consent during the study they should be re-consented at the next study visit).
  • Participant must have a score of 3 (moderate) or 4 (severe) on the EGSS assessment at the screening and baseline visit

Key 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.
  • 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.
  • Participants with a facial beard or mustache that could interfere with the study assessments.

Sites / Locations

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

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

IDP-121 Lotion

IDP-121 Vehicle Lotion

Arm Description

IDP-121 lotion (tretinoin 0.05 percent [%]) will be applied topically to the face of participants with moderate to severe acne, once daily for 12 weeks.

IDP-121 lotion vehicle will be applied topically to the face of participants with moderate to severe acne, once daily for 12 weeks.

Outcomes

Primary Outcome Measures

Absolute Change From Baseline in Mean Noninflammatory Lesion Count to Week 12
Noninflammatory lesions were defined as follows: Open comedones (blackhead) - plugged hair follicle with dilated/open orifice, black in color; and Closed comedones (whitehead) - plugged hair follicle: small opening at skin surface. For noninflammatory facial lesions, open and closed comedones were recorded as a single count.
Absolute Change From Baseline in Mean Inflammatory Lesion Count to Week 12
Inflammatory lesions were defined as follows: Papule - a solid, elevated lesion less than 5 millimeters (mm); and Pustule - an elevated lesion containing pus less than 5 mm. For inflammatory facial lesions, papules and pustules were recorded as a single count, while nodular lesions were counted and recorded separately.
Percentage of Participants With Treatment Success at Week 12
Treatment success was defined as at least a 2-grade reduction from Baseline in EGSS score and an EGSS score equating to "Clear" or "Almost Clear". EGSS was based on a 5-point scale ranging from 0 to 4; where 0 = clear, 1 = almost clear, 2 = mild, 3 = moderate, and 4 = severe.

Secondary Outcome Measures

Percent Change From Baseline in Noninflammatory Lesion Count to Week 12
Noninflammatory lesions were defined as follows: Open comedones (blackhead) - plugged hair follicle with dilated/open orifice, black in color; and Closed comedones (whitehead) - plugged hair follicle: small opening at skin surface. For noninflammatory facial lesions, open and closed comedones were recorded as a single count.
Percent Change From Baseline in Inflammatory Lesion Count to Week 12
Inflammatory lesions were defined as follows: Papule - a solid, elevated lesion less than 5 millimeters (mm); and Pustule - an elevated lesion containing pus less than 5 mm. For inflammatory facial lesions, papules and pustules were recorded as a single count, while nodular lesions were counted and recorded separately.

Full Information

First Posted
October 11, 2016
Last Updated
December 16, 2019
Sponsor
Bausch Health Americas, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT02932306
Brief Title
Efficacy and Safety of IDP-121 and IDP-121 Vehicle Lotion in the Treatment of Acne Vulgaris
Official Title
A Phase 3, Multi-Center, Randomized, Double-Blind, Vehicle- Controlled, 2-Arm, Parallel Group Comparison Study Comparing the Efficacy and Safety of IDP-121 and IDP-121 Vehicle Lotion in the Treatment of Acne Vulgaris
Study Type
Interventional

2. Study Status

Record Verification Date
December 2019
Overall Recruitment Status
Completed
Study Start Date
November 3, 2015 (Actual)
Primary Completion Date
February 22, 2017 (Actual)
Study Completion Date
February 22, 2017 (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
The objective of this study was to evaluate the efficacy, safety, and tolerability of a once daily topical application of IDP-121 Lotion compared with its vehicle (IDP-121 Vehicle Lotion) in participants with moderate to severe acne vulgaris (acne) (that is, acne having an Evaluator's Global Severity Score [EGSS] of 3 [moderate] or 4 [severe]).

6. Conditions and Keywords

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

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
820 (Actual)

8. Arms, Groups, and Interventions

Arm Title
IDP-121 Lotion
Arm Type
Experimental
Arm Description
IDP-121 lotion (tretinoin 0.05 percent [%]) will be applied topically to the face of participants with moderate to severe acne, once daily for 12 weeks.
Arm Title
IDP-121 Vehicle Lotion
Arm Type
Placebo Comparator
Arm Description
IDP-121 lotion vehicle will be applied topically to the face of participants with moderate to severe acne, once daily for 12 weeks.
Intervention Type
Drug
Intervention Name(s)
IDP-121 Lotion
Intervention Description
IDP-121 lotion will be applied as per the instructions provided by the investigational center staff.
Intervention Type
Drug
Intervention Name(s)
IDP-121 Vehicle Lotion
Intervention Description
IDP-121 vehicle lotion will be applied as per the instructions provided by the investigational center staff.
Primary Outcome Measure Information:
Title
Absolute Change From Baseline in Mean Noninflammatory Lesion Count to Week 12
Description
Noninflammatory lesions were defined as follows: Open comedones (blackhead) - plugged hair follicle with dilated/open orifice, black in color; and Closed comedones (whitehead) - plugged hair follicle: small opening at skin surface. For noninflammatory facial lesions, open and closed comedones were recorded as a single count.
Time Frame
Baseline (Day 0), Week 12
Title
Absolute Change From Baseline in Mean Inflammatory Lesion Count to Week 12
Description
Inflammatory lesions were defined as follows: Papule - a solid, elevated lesion less than 5 millimeters (mm); and Pustule - an elevated lesion containing pus less than 5 mm. For inflammatory facial lesions, papules and pustules were recorded as a single count, while nodular lesions were counted and recorded separately.
Time Frame
Baseline, Week 12
Title
Percentage of Participants With Treatment Success at Week 12
Description
Treatment success was defined as at least a 2-grade reduction from Baseline in EGSS score and an EGSS score equating to "Clear" or "Almost Clear". EGSS was based on a 5-point scale ranging from 0 to 4; where 0 = clear, 1 = almost clear, 2 = mild, 3 = moderate, and 4 = severe.
Time Frame
Baseline, Week 12
Secondary Outcome Measure Information:
Title
Percent Change From Baseline in Noninflammatory Lesion Count to Week 12
Description
Noninflammatory lesions were defined as follows: Open comedones (blackhead) - plugged hair follicle with dilated/open orifice, black in color; and Closed comedones (whitehead) - plugged hair follicle: small opening at skin surface. For noninflammatory facial lesions, open and closed comedones were recorded as a single count.
Time Frame
Baseline, Week 12
Title
Percent Change From Baseline in Inflammatory Lesion Count to Week 12
Description
Inflammatory lesions were defined as follows: Papule - a solid, elevated lesion less than 5 millimeters (mm); and Pustule - an elevated lesion containing pus less than 5 mm. For inflammatory facial lesions, papules and pustules were recorded as a single count, while nodular lesions were counted and recorded separately.
Time Frame
Baseline, Week 12

10. Eligibility

Sex
All
Minimum Age & Unit of Time
9 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Key Inclusion Criteria: Male or female at least 9 years of age and older. Written and verbal informed consent must be obtained. Participants 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 participant reaches age of consent during the study they should be re-consented at the next study visit). Participant must have a score of 3 (moderate) or 4 (severe) on the EGSS assessment at the screening and baseline visit Key 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. 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. Participants with a facial beard or mustache that could interfere with the study assessments.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Tim Theisen
Organizational Affiliation
TKL Research, Inc.
Official's Role
Study Chair
Facility Information:
Facility Name
Valeant Site 36
City
Guntersville
State/Province
Alabama
ZIP/Postal Code
35976
Country
United States
Facility Name
Valeant Site 14
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85032
Country
United States
Facility Name
Valeant Site 28
City
Hot Springs
State/Province
Arkansas
ZIP/Postal Code
71913
Country
United States
Facility Name
Valeant Site 38
City
Fountain Valley
State/Province
California
ZIP/Postal Code
92708
Country
United States
Facility Name
Valeant Site 34
City
Manhattan Beach
State/Province
California
ZIP/Postal Code
90266
Country
United States
Facility Name
Valeant Site 23
City
Oceanside
State/Province
California
ZIP/Postal Code
92056
Country
United States
Facility Name
Valeant Site 35
City
Rancho Cucamonga
State/Province
California
ZIP/Postal Code
91730
Country
United States
Facility Name
Valeant Site 20
City
San Diego
State/Province
California
ZIP/Postal Code
92123
Country
United States
Facility Name
Valeant Site 32
City
Denver
State/Province
Colorado
ZIP/Postal Code
80220
Country
United States
Facility Name
Valeant Site 10
City
Shelton
State/Province
Connecticut
ZIP/Postal Code
06484
Country
United States
Facility Name
Valeant Site 02
City
Boynton Beach
State/Province
Florida
ZIP/Postal Code
33437
Country
United States
Facility Name
Valeant Site 15
City
Coral Gables
State/Province
Florida
ZIP/Postal Code
33146
Country
United States
Facility Name
Valeant Site 37
City
Miami
State/Province
Florida
ZIP/Postal Code
33142
Country
United States
Facility Name
Valeant Site 39
City
Pembroke Pines
State/Province
Florida
ZIP/Postal Code
33028
Country
United States
Facility Name
Valeant Site 01
City
West Palm Beach
State/Province
Florida
ZIP/Postal Code
33401
Country
United States
Facility Name
Valeant Site 19
City
Boise
State/Province
Idaho
ZIP/Postal Code
83704
Country
United States
Facility Name
Valeant Site 04
City
Arlington Heights
State/Province
Illinois
ZIP/Postal Code
60005
Country
United States
Facility Name
Valeant Site 27
City
Carmel
State/Province
Indiana
ZIP/Postal Code
46032
Country
United States
Facility Name
Valeant 12
City
Plainfield
State/Province
Indiana
ZIP/Postal Code
46168
Country
United States
Facility Name
Valeant Site 09
City
Louisville
State/Province
Kentucky
ZIP/Postal Code
40202
Country
United States
Facility Name
Valeant Site 16
City
Louisville
State/Province
Kentucky
ZIP/Postal Code
40217
Country
United States
Facility Name
Valeant Site 33
City
Needham
State/Province
Massachusetts
ZIP/Postal Code
02492
Country
United States
Facility Name
Valeant Site 11
City
Warren
State/Province
Michigan
ZIP/Postal Code
48088
Country
United States
Facility Name
Valeant Site 08
City
Omaha
State/Province
Nebraska
ZIP/Postal Code
68114
Country
United States
Facility Name
Valeant Site 25
City
Omaha
State/Province
Nebraska
ZIP/Postal Code
68144
Country
United States
Facility Name
Valeant Site 13
City
Berlin
State/Province
New Jersey
ZIP/Postal Code
08009
Country
United States
Facility Name
Valeant Site 03
City
Albuquerque
State/Province
New Mexico
ZIP/Postal Code
87106
Country
United States
Facility Name
Valeant Site 26
City
New York
State/Province
New York
ZIP/Postal Code
10022
Country
United States
Facility Name
Valeant Site 31
City
Stony Brook
State/Province
New York
ZIP/Postal Code
11790
Country
United States
Facility Name
Valeant 05
City
Gresham
State/Province
Oregon
ZIP/Postal Code
97030
Country
United States
Facility Name
Valeant Site 22
City
Fort Washington
State/Province
Pennsylvania
ZIP/Postal Code
19034
Country
United States
Facility Name
Valeant Site 24
City
Charleston
State/Province
South Carolina
ZIP/Postal Code
29414
Country
United States
Facility Name
Valeant Site 06
City
Dallas
State/Province
Texas
ZIP/Postal Code
75231
Country
United States
Facility Name
Valeant Site 30
City
Houston
State/Province
Texas
ZIP/Postal Code
77004
Country
United States
Facility Name
Valeant Site 17
City
Pflugerville
State/Province
Texas
ZIP/Postal Code
78660
Country
United States
Facility Name
Valeant Site 07
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78229
Country
United States
Facility Name
Valeant 18
City
Webster
State/Province
Texas
ZIP/Postal Code
77598
Country
United States
Facility Name
Valeant Site 29
City
Salt Lake City
State/Province
Utah
ZIP/Postal Code
84117
Country
United States
Facility Name
Valeant Site 21
City
Norfolk
State/Province
Virginia
ZIP/Postal Code
23502
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
Undecided
Citations:
PubMed Identifier
32886337
Citation
Tyring SK, Kircik L, Pariser DM, Woolery-Lloyd HC, Harper JC, Bhatt V, Pillai R, Guenin E. The Effects of Once-Daily Tretinoin 0.05% Lotion on Quality of Life in Patients with Moderate-to-Severe Acne Vulgaris. Am J Clin Dermatol. 2020 Dec;21(6):891-899. doi: 10.1007/s40257-020-00559-3.
Results Reference
derived

Learn more about this trial

Efficacy and Safety of IDP-121 and IDP-121 Vehicle Lotion in the Treatment of Acne Vulgaris

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