Safety and Efficacy of IDP-118 in the Treatment of Plaque Psoriasis
Primary Purpose
Plaque Psoriasis
Status
Completed
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
IDP-118 Lotion
IDP-118 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 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 in this assessment).
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 5
- Valeant Site 2
- Valeant Site 14
- Valeant Site 13
- Valeant Site 8
- Valeant Site 10
- Valeant Site 1
- Valeant Site 4
- Valeant Site 12
- Valeant Site 6
- Valeant Site 3
- Valeant Site 7
- Valeant Site 9
- Valeant Site 15
- Valeant Site 16
- Valeant Site 11
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
IDP-118 Lotion
IDP-118 Vehicle Lotion
Arm Description
Lotion
Vehicle Lotion
Outcomes
Primary Outcome Measures
The Percentage of Participants With Treatment Success at Week 8
Treatment success was defined as at least a 2-grade improvement from Baseline in IGA score and an IGA score equating to "Clear" or "Almost Clear". IGA 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
Percentage of Participants With Treatment Success at Weeks 12, 6, 4, and 2
Treatment success was defined as at least a 2-grade improvement from Baseline in IGA score and an IGA score equating to "Clear" or "Almost Clear". IGA 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.
Full Information
NCT ID
NCT02462122
First Posted
June 1, 2015
Last Updated
August 8, 2020
Sponsor
Bausch Health Americas, Inc.
Collaborators
Dow Pharmaceutical Sciences
1. Study Identification
Unique Protocol Identification Number
NCT02462122
Brief Title
Safety and Efficacy of IDP-118 in the Treatment of Plaque Psoriasis
Official Title
A Phase 3, Multicenter, Double-Blind, Randomized, Vehicle Controlled Clinical Study to Assess the Safety and Efficacy of IDP-118 in the Treatment of Plaque Psoriasis
Study Type
Interventional
2. Study Status
Record Verification Date
August 2020
Overall Recruitment Status
Completed
Study Start Date
August 19, 2015 (Actual)
Primary Completion Date
November 9, 2016 (Actual)
Study Completion Date
November 14, 2016 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Bausch Health Americas, Inc.
Collaborators
Dow Pharmaceutical Sciences
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
Safety and Efficacy of IDP-118 in the treatment of plaque psoriasis
Detailed Description
A Phase 3, Multicenter, Double-Blind, Randomized, Vehicle Controlled Clinical Study to Assess the Safety and Efficacy of IDP-118 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
Plaque Psoriasis
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
215 (Actual)
8. Arms, Groups, and Interventions
Arm Title
IDP-118 Lotion
Arm Type
Experimental
Arm Description
Lotion
Arm Title
IDP-118 Vehicle Lotion
Arm Type
Active Comparator
Arm Description
Vehicle Lotion
Intervention Type
Drug
Intervention Name(s)
IDP-118 Lotion
Other Intervention Name(s)
Lotion
Intervention Description
Lotion
Intervention Type
Drug
Intervention Name(s)
IDP-118 Vehicle Lotion
Other Intervention Name(s)
Vehicle
Intervention Description
Lotion
Primary Outcome Measure Information:
Title
The Percentage of Participants With Treatment Success at Week 8
Description
Treatment success was defined as at least a 2-grade improvement from Baseline in IGA score and an IGA score equating to "Clear" or "Almost Clear". IGA 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
8 weeks
Secondary Outcome Measure Information:
Title
Percentage of Participants With Treatment Success at Weeks 12, 6, 4, and 2
Description
Treatment success was defined as at least a 2-grade improvement from Baseline in IGA score and an IGA score equating to "Clear" or "Almost Clear". IGA 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
12 weeks
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 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 in this assessment).
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 5
City
Fremont
State/Province
California
ZIP/Postal Code
94536
Country
United States
Facility Name
Valeant Site 2
City
Boynton Beach
State/Province
Florida
ZIP/Postal Code
33424
Country
United States
Facility Name
Valeant Site 14
City
North Miami Beach
State/Province
Florida
ZIP/Postal Code
33160
Country
United States
Facility Name
Valeant Site 13
City
Detroit
State/Province
Michigan
ZIP/Postal Code
48201
Country
United States
Facility Name
Valeant Site 8
City
Warren
State/Province
Michigan
ZIP/Postal Code
48088
Country
United States
Facility Name
Valeant Site 10
City
Fridley
State/Province
Minnesota
ZIP/Postal Code
55421
Country
United States
Facility Name
Valeant Site 1
City
East Windsor
State/Province
New Jersey
ZIP/Postal Code
08520
Country
United States
Facility Name
Valeant Site 4
City
Albuquerque
State/Province
New Mexico
ZIP/Postal Code
87103
Country
United States
Facility Name
Valeant Site 12
City
New York
State/Province
New York
ZIP/Postal Code
10001
Country
United States
Facility Name
Valeant Site 6
City
High Point
State/Province
North Carolina
ZIP/Postal Code
27260
Country
United States
Facility Name
Valeant Site 3
City
Portland
State/Province
Oregon
ZIP/Postal Code
97201
Country
United States
Facility Name
Valeant Site 7
City
Knoxville
State/Province
Tennessee
ZIP/Postal Code
37909
Country
United States
Facility Name
Valeant Site 9
City
College Station
State/Province
Texas
ZIP/Postal Code
77840
Country
United States
Facility Name
Valeant Site 15
City
Houston
State/Province
Texas
ZIP/Postal Code
77001
Country
United States
Facility Name
Valeant Site 16
City
Houston
State/Province
Texas
ZIP/Postal Code
77001
Country
United States
Facility Name
Valeant Site 11
City
Pflugerville
State/Province
Texas
ZIP/Postal Code
78660
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Learn more about this trial
Safety and Efficacy of IDP-118 in the Treatment of Plaque Psoriasis
We'll reach out to this number within 24 hrs