Safety and Efficacy of IDP-122 Lotion When Applied Topically to Subjects With Moderate to Severe Plaque Psoriasis
Primary Purpose
Psoriasis
Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
IDP-122 Vehicle Lotion
IDP-122 Vehicle Cream
IDP-122 Lotion
Ultravate Cream
Sponsored by
About this trial
This is an interventional treatment trial for 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.
- Is willing and able to avoid prolonged exposure of the treatment area to ultraviolet radiation (natural and artificial) for the duration of the study.
- Subject is willing to comply with study instructions and return to the clinic for required visits.
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 05
- Valeant Site 10
- Valeant Site 09
- Valeant Site 13
- Valeant Site 12
- Valeant Site 07
- Valeant Site 11
- Valeant Site 03
- Valeant Site 08
- Valeant Site 04
- Valeant Site 06
- Valeant Site 02
- Valeant Site 01
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm Type
Experimental
Active Comparator
Active Comparator
Active Comparator
Arm Label
IDP-122 Lotion
Ultravate Cream
IDP-122 Vehicle Lotion
IDP-122 Vehicle Cream
Arm Description
Lotion
Cream
Lotion
Cream
Outcomes
Primary Outcome Measures
Percentage of Participants With Treatment Success of a 2-Grade IGA Score Improvement From Baseline and an IGA Score of Clear or Almost Clear at Week 2
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 Week 2. 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).
Secondary Outcome Measures
Full Information
NCT ID
NCT02785185
First Posted
April 26, 2016
Last Updated
August 19, 2020
Sponsor
Bausch Health Americas, Inc.
1. Study Identification
Unique Protocol Identification Number
NCT02785185
Brief Title
Safety and Efficacy of IDP-122 Lotion When Applied Topically to Subjects With Moderate to Severe Plaque Psoriasis
Official Title
A Phase 2, Multi-Center, Double-Blind, Randomized, Vehicle-Controlled Study to Compare the Safety and Efficacy of IDP-122 Lotion (0.01% Halobetasol Propionate) to Ultravate® (Halobetasol Propionate) Cream, in the Treatment of Plaque Psoriasis
Study Type
Interventional
2. Study Status
Record Verification Date
August 2020
Overall Recruitment Status
Completed
Study Start Date
June 2016 (Actual)
Primary Completion Date
December 2, 2016 (Actual)
Study Completion Date
January 2017 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Bausch Health Americas, Inc.
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
A Phase 2, Multi-Center, Double-Blind, Randomized, Vehicle-Controlled Study.
Detailed Description
A Phase 2, Multi-Center, Double-Blind, Randomized, Vehicle-Controlled Study to Compare the Safety and Efficacy of IDP-122 Lotion (0.01% halobetasol propionate) to Ultravate® (halobetasol propionate) Cream, 0.05% in the Treatment of Plaque Psoriasis.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Psoriasis
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
150 (Actual)
8. Arms, Groups, and Interventions
Arm Title
IDP-122 Lotion
Arm Type
Experimental
Arm Description
Lotion
Arm Title
Ultravate Cream
Arm Type
Active Comparator
Arm Description
Cream
Arm Title
IDP-122 Vehicle Lotion
Arm Type
Active Comparator
Arm Description
Lotion
Arm Title
IDP-122 Vehicle Cream
Arm Type
Active Comparator
Arm Description
Cream
Intervention Type
Drug
Intervention Name(s)
IDP-122 Vehicle Lotion
Other Intervention Name(s)
Lotion
Intervention Description
Vehicle
Intervention Type
Drug
Intervention Name(s)
IDP-122 Vehicle Cream
Other Intervention Name(s)
Cream
Intervention Description
Vehicle
Intervention Type
Drug
Intervention Name(s)
IDP-122 Lotion
Other Intervention Name(s)
Lotion
Intervention Description
Lotion
Intervention Type
Drug
Intervention Name(s)
Ultravate Cream
Other Intervention Name(s)
Ultravate
Intervention Description
Cream
Primary Outcome Measure Information:
Title
Percentage of Participants With Treatment Success of a 2-Grade IGA Score Improvement From Baseline and an IGA Score of Clear or Almost Clear at Week 2
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 Week 2. 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).
Time Frame
2 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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.
Is willing and able to avoid prolonged exposure of the treatment area to ultraviolet radiation (natural and artificial) for the duration of the study.
Subject is willing to comply with study instructions and return to the clinic for required visits.
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, MD
Organizational Affiliation
Valeant Pharmaceuticals
Official's Role
Study Director
Facility Information:
Facility Name
Valeant Site 05
City
Rogers
State/Province
Arkansas
ZIP/Postal Code
75758
Country
United States
Facility Name
Valeant Site 10
City
Beverly Hills
State/Province
California
ZIP/Postal Code
90210
Country
United States
Facility Name
Valeant Site 09
City
Carlsbad
State/Province
California
ZIP/Postal Code
92008
Country
United States
Facility Name
Valeant Site 13
City
Los Angeles
State/Province
California
ZIP/Postal Code
90045
Country
United States
Facility Name
Valeant Site 12
City
Santa Monica
State/Province
California
ZIP/Postal Code
90404
Country
United States
Facility Name
Valeant Site 07
City
Coral Gables
State/Province
Florida
ZIP/Postal Code
33134
Country
United States
Facility Name
Valeant Site 11
City
North Miami Beach
State/Province
Florida
ZIP/Postal Code
33162
Country
United States
Facility Name
Valeant Site 03
City
Sanford
State/Province
Florida
ZIP/Postal Code
32771
Country
United States
Facility Name
Valeant Site 08
City
Albany
State/Province
Indiana
ZIP/Postal Code
47150
Country
United States
Facility Name
Valeant Site 04
City
Louisville
State/Province
Kentucky
ZIP/Postal Code
40202
Country
United States
Facility Name
Valeant Site 06
City
Fridley
State/Province
Minnesota
ZIP/Postal Code
55432
Country
United States
Facility Name
Valeant Site 02
City
High Point
State/Province
North Carolina
ZIP/Postal Code
27262
Country
United States
Facility Name
Valeant Site 01
City
Houston
State/Province
Texas
ZIP/Postal Code
77065
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
Yes
Citations:
PubMed Identifier
30207807
Citation
Kerdel FA, Draelos ZD, Tyring SK, Lin T, Pillai R. A phase 2, multicenter, double-blind, randomized, vehicle-controlled clinical study to compare the safety and efficacy of a halobetasol propionate 0.01% lotion and halobetasol propionate 0.05% cream in the treatment of plaque psoriasis. J Dermatolog Treat. 2019 Jun;30(4):333-339. doi: 10.1080/09546634.2018.1523362. Epub 2018 Nov 5.
Results Reference
derived
Learn more about this trial
Safety and Efficacy of IDP-122 Lotion When Applied Topically to Subjects With Moderate to Severe Plaque Psoriasis
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