Safety and Efficacy of IDP-122 in the Treatment of Participants With Plaque Psoriasis
Primary Purpose
Plaque Psoriasis
Status
Completed
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
IDP-122 Lotion
IDP-122 Vehicle Lotion
Sponsored by
About this trial
This is an interventional treatment trial for Plaque Psoriasis
Eligibility Criteria
Key Inclusion Criteria:
- Male or female, of any race, at least 18 years of age (inclusive).
- Freely provides both verbal and written informed consent.
- Has an area of plaque psoriasis appropriate for topical treatment that covers a body surface area (BSA) of at least 3%, but no more than 12%. The face, scalp, palms, soles, axillae, and intertriginous areas are to be excluded in this calculation.
- Is willing and able to avoid prolonged exposure of the treatment area to ultraviolet radiation (natural and artificial) for the duration of the study.
- Has a clinical diagnosis of psoriasis at the Baseline visit with an IGA score of 3 or 4 (the face, scalp, palms, soles, axillae, and intertriginous areas are to be excluded from this calculation, if psoriasis is present).
Key Exclusion Criteria:
- Has spontaneously improving or rapidly deteriorating plaque psoriasis or pustular psoriasis, as determined by the Investigator.
- Presents with psoriasis that was treated with prescription medication and failed to respond to treatment, even partially or temporarily, as determined by the Investigator.
- Presents with any concurrent skin condition that could interfere with the evaluation of the treatment areas, as determined by the Investigator.
- Is pregnant, nursing an infant, or planning a pregnancy during the study period.
- Has received treatment with any investigational drug or device within 60 days or 5 drug half-lives (whichever is longer) prior to the Baseline visit or is concurrently participating in another clinical study with an investigational drug or device.
Sites / Locations
- Valeant Site 11
- Valeant Site 1
- Valeant Site 10
- Valeant Site 12
- Valeant Site 13
- Valeant Site 7
- Valeant Site 6
- Valeant Site 4
- Valeant Site 8
- Valeant Site 15
- Valeant Site 9
- Valeant Site 5
- Valeant Site 3
- Valeant Site 2
- Valeant Site 14
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
IDP-122 Lotion
IDP-122 Vehicle Lotion
Arm Description
Participants will apply IDP-122 Lotion (halobetasol propionate [HP] 0.01%) topically once daily for 8 weeks.
Participants will apply IDP-122 Vehicle Lotion topically once daily for 8 weeks.
Outcomes
Primary Outcome Measures
Percentage of Participants With Treatment Success at Week 8
Treatment success defined as at least a 2-grade improvement from Baseline in the IGA score and an IGA score equating to "clear" or "almost clear" at Week 8. The IGA score was based on a 5-point scale ranging from 0 to 4 (0=clear, 1=almost clear, 2=mild, 3=moderate, and 4=severe). The face, scalp, palms, soles, axillae, and intertriginous areas were excluded from this assessment.
Secondary Outcome Measures
Percentage of Participants With Treatment Success at Weeks 2, 4, 6, and 12
Treatment success defined as at least a 2-grade improvement from Baseline in the Investigator's Global Assessment (IGA) score and an IGA score equating to "clear" or "almost clear" at Weeks 2, 4, 6, and 12. The IGA score was based on a 5-point scale ranging from 0 to 4 (0=clear, 1=almost clear, 2=mild, 3=moderate, and 4=severe). The face, scalp, palms, soles, axillae, and intertriginous areas were excluded from this assessment.
Full Information
NCT ID
NCT02514577
First Posted
July 31, 2015
Last Updated
January 14, 2020
Sponsor
Bausch Health Americas, Inc.
1. Study Identification
Unique Protocol Identification Number
NCT02514577
Brief Title
Safety and Efficacy of IDP-122 in the Treatment of Participants With Plaque Psoriasis
Official Title
A Phase 3, Multicenter, Double-Blind, Randomized, Vehicle Controlled Clinical Study to Assess the Safety and Efficacy of IDP-122 in the Treatment of Plaque Psoriasis
Study Type
Interventional
2. Study Status
Record Verification Date
January 2020
Overall Recruitment Status
Completed
Study Start Date
November 7, 2015 (Actual)
Primary Completion Date
May 1, 2017 (Actual)
Study Completion Date
May 1, 2017 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Bausch Health Americas, Inc.
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
This study is to evaluate the safety and efficacy of a topical lotion when applied once daily to adult participants with moderate to severe plaque psoriasis (defined as an Investigator's Global Assessment [IGA] score of 3 or 4).
Detailed Description
This study is a multicenter, double-blind, randomized, parallel-group study designed to assess the safety and efficacy of IDP-122 Lotion in comparison with its vehicle. To be eligible for the study, participants must be at least 18 years of age and have a clinical diagnosis of moderate to severe psoriasis (defined as an IGA score of 3 or 4).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Plaque Psoriasis
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
217 (Actual)
8. Arms, Groups, and Interventions
Arm Title
IDP-122 Lotion
Arm Type
Experimental
Arm Description
Participants will apply IDP-122 Lotion (halobetasol propionate [HP] 0.01%) topically once daily for 8 weeks.
Arm Title
IDP-122 Vehicle Lotion
Arm Type
Active Comparator
Arm Description
Participants will apply IDP-122 Vehicle Lotion topically once daily for 8 weeks.
Intervention Type
Drug
Intervention Name(s)
IDP-122 Lotion
Other Intervention Name(s)
HP 0.01%
Intervention Description
Topical lotion
Intervention Type
Drug
Intervention Name(s)
IDP-122 Vehicle Lotion
Intervention Description
Topical lotion. No active ingredient.
Primary Outcome Measure Information:
Title
Percentage of Participants With Treatment Success at Week 8
Description
Treatment success defined as at least a 2-grade improvement from Baseline in the IGA score and an IGA score equating to "clear" or "almost clear" at Week 8. The IGA score was based on a 5-point scale ranging from 0 to 4 (0=clear, 1=almost clear, 2=mild, 3=moderate, and 4=severe). The face, scalp, palms, soles, axillae, and intertriginous areas were excluded from this assessment.
Time Frame
Week 8
Secondary Outcome Measure Information:
Title
Percentage of Participants With Treatment Success at Weeks 2, 4, 6, and 12
Description
Treatment success defined as at least a 2-grade improvement from Baseline in the Investigator's Global Assessment (IGA) score and an IGA score equating to "clear" or "almost clear" at Weeks 2, 4, 6, and 12. The IGA score was based on a 5-point scale ranging from 0 to 4 (0=clear, 1=almost clear, 2=mild, 3=moderate, and 4=severe). The face, scalp, palms, soles, axillae, and intertriginous areas were excluded from this assessment.
Time Frame
Weeks 2, 4, 6, and 12 (4-week follow-up)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Key Inclusion Criteria:
Male or female, of any race, at least 18 years of age (inclusive).
Freely provides both verbal and written informed consent.
Has an area of plaque psoriasis appropriate for topical treatment that covers a body surface area (BSA) of at least 3%, but no more than 12%. The face, scalp, palms, soles, axillae, and intertriginous areas are to be excluded in this calculation.
Is willing and able to avoid prolonged exposure of the treatment area to ultraviolet radiation (natural and artificial) for the duration of the study.
Has a clinical diagnosis of psoriasis at the Baseline visit with an IGA score of 3 or 4 (the face, scalp, palms, soles, axillae, and intertriginous areas are to be excluded from this calculation, if psoriasis is present).
Key Exclusion Criteria:
Has spontaneously improving or rapidly deteriorating plaque psoriasis or pustular psoriasis, as determined by the Investigator.
Presents with psoriasis that was treated with prescription medication and failed to respond to treatment, even partially or temporarily, as determined by the Investigator.
Presents with any concurrent skin condition that could interfere with the evaluation of the treatment areas, as determined by the Investigator.
Is pregnant, nursing an infant, or planning a pregnancy during the study period.
Has received treatment with any investigational drug or device within 60 days or 5 drug half-lives (whichever is longer) prior to the Baseline visit or is concurrently participating in another clinical study with an investigational drug or device.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Binu j Alexander
Organizational Affiliation
Valeant Pharmaceuticals
Official's Role
Study Director
Facility Information:
Facility Name
Valeant Site 11
City
Hot Springs
State/Province
Arkansas
ZIP/Postal Code
71901
Country
United States
Facility Name
Valeant Site 1
City
Encinitas
State/Province
California
ZIP/Postal Code
92023
Country
United States
Facility Name
Valeant Site 10
City
Encino
State/Province
California
ZIP/Postal Code
91436
Country
United States
Facility Name
Valeant Site 12
City
Santa Rosa
State/Province
California
ZIP/Postal Code
95401
Country
United States
Facility Name
Valeant Site 13
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30301
Country
United States
Facility Name
Valeant Site 7
City
Boise
State/Province
Idaho
ZIP/Postal Code
83701
Country
United States
Facility Name
Valeant Site 6
City
Rockville
State/Province
Maryland
ZIP/Postal Code
20847
Country
United States
Facility Name
Valeant Site 4
City
Ann Arbor
State/Province
Michigan
ZIP/Postal Code
48103
Country
United States
Facility Name
Valeant Site 8
City
Clarkston
State/Province
Michigan
ZIP/Postal Code
48346
Country
United States
Facility Name
Valeant Site 15
City
Las Vegas
State/Province
Nevada
ZIP/Postal Code
89101
Country
United States
Facility Name
Valeant Site 9
City
Raleigh
State/Province
North Carolina
ZIP/Postal Code
27601
Country
United States
Facility Name
Valeant Site 5
City
Knoxville
State/Province
Tennessee
ZIP/Postal Code
37901
Country
United States
Facility Name
Valeant Site 3
City
Austin
State/Province
Texas
ZIP/Postal Code
73301
Country
United States
Facility Name
Valeant Site 2
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78201
Country
United States
Facility Name
Valeant Site 14
City
Spokane
State/Province
Washington
ZIP/Postal Code
99201
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
Yes
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Safety and Efficacy of IDP-122 in the Treatment of Participants With Plaque Psoriasis
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