Long-Term Safety of IDP-118 Lotion 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
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 percent (%), 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 Investigators Global Assessment (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 6
- Valeant Site 24
- Valeant Site 32
- Valeant Site 27
- Valeant Site 33
- Valeant Site 43
- Valeant Site 45
- Valeant Site 25
- Valeant Site 4
- Valeant Site 44
- Valeant Site 36
- Valeant Site 10
- Valeant Site 3
- Valeant Site 28
- Valeant Site 1
- Valeant Site 37
- Valeant Site 13
- Valeant Site 41
- Valeant Site 17
- Valeant Site 12
- Valeant Site 19
- Valeant Site 14
- Valeant Site 35
- Valeant Site 34
- Valeant Site 16
- Valeant Site 18
- Valeant Site 31
- Valeant Site 2
- Valeant Site 29
- Valeant Site 39
- Valeant Site 5
- Valeant Site 11
- Valeant Site 30
- Valeant Site 15
- Valeant Site 9
- Valeant Site 40
- Valeant Site 8
- Valeant Site 46
- Valeant Site 20
- Valeant Site 21
- Valeant Site 7
- Valeant Site 22
- Valeant Site 38
- Valeant Site 23
- Valeant Site 26
- Valeant Site 42
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
IDP-118 Lotion
Arm Description
IDP-118 lotion (halobetasol propionate 0.01%, tazarotene 0.045%) will be applied topically on the affected area once daily for 8 weeks and then as needed once daily for up to 1 year.
Outcomes
Primary Outcome Measures
Percentage of Participants Who Experienced Grade 3 Local Skin Reactions
Local skin reactions (itching, dryness, burning/stinging) graded at a level of 3 (severe) at any point in the study following the first application of study drug were assessed. Severe Itching (as reported by the participant within the last 24 hours) referred to the intense itching that may interrupt daily activities and/or sleep. Severe dryness (as assessed by the investigator) referred to as marked roughness of the skin. Severe burning/stinging (as reported by the participant within the last 24 hours) referred to as hot burning sensation that causes definite discomfort and may interrupt daily activities and/or sleep. A summary of serious and all other non-serious adverse events, regardless of causality, is located in the Reported Adverse Events module.
Secondary Outcome Measures
Full Information
NCT ID
NCT02462083
First Posted
June 1, 2015
Last Updated
January 14, 2020
Sponsor
Bausch Health Americas, Inc.
Collaborators
Dow Pharmaceutical Sciences
1. Study Identification
Unique Protocol Identification Number
NCT02462083
Brief Title
Long-Term Safety of IDP-118 Lotion in the Treatment of Plaque Psoriasis
Official Title
A Phase 3, Multicenter, Open Label Study to Evaluate the Long-Term Safety of IDP-118 Lotion in the Treatment of Plaque Psoriasis
Study Type
Interventional
2. Study Status
Record Verification Date
January 2020
Overall Recruitment Status
Completed
Study Start Date
August 11, 2015 (Actual)
Primary Completion Date
January 31, 2017 (Actual)
Study Completion Date
April 24, 2017 (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
The objective of this study is to evaluate the long-term safety of IDP-118 lotion.
Detailed Description
This is a multicenter, open-label study of the long-term safety of IDP-118 lotion in participants with 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
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
555 (Actual)
8. Arms, Groups, and Interventions
Arm Title
IDP-118 Lotion
Arm Type
Experimental
Arm Description
IDP-118 lotion (halobetasol propionate 0.01%, tazarotene 0.045%) will be applied topically on the affected area once daily for 8 weeks and then as needed once daily for up to 1 year.
Intervention Type
Drug
Intervention Name(s)
IDP-118 Lotion
Intervention Description
IDP-118 lotion will be applied as per the instructions provided by the investigational center staff.
Primary Outcome Measure Information:
Title
Percentage of Participants Who Experienced Grade 3 Local Skin Reactions
Description
Local skin reactions (itching, dryness, burning/stinging) graded at a level of 3 (severe) at any point in the study following the first application of study drug were assessed. Severe Itching (as reported by the participant within the last 24 hours) referred to the intense itching that may interrupt daily activities and/or sleep. Severe dryness (as assessed by the investigator) referred to as marked roughness of the skin. Severe burning/stinging (as reported by the participant within the last 24 hours) referred to as hot burning sensation that causes definite discomfort and may interrupt daily activities and/or sleep. A summary of serious and all other non-serious adverse events, regardless of causality, is located in the Reported Adverse Events module.
Time Frame
Baseline up to Week 52
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 percent (%), 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 Investigators Global Assessment (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
Organizational Affiliation
Valeant Pharmaceuticals
Official's Role
Study Director
Facility Information:
Facility Name
Valeant Site 6
City
Mobile
State/Province
Alabama
ZIP/Postal Code
36603
Country
United States
Facility Name
Valeant Site 24
City
Beverly Hills
State/Province
California
ZIP/Postal Code
90210
Country
United States
Facility Name
Valeant Site 32
City
Encinitas
State/Province
California
ZIP/Postal Code
92023
Country
United States
Facility Name
Valeant Site 27
City
Encino
State/Province
California
ZIP/Postal Code
91436
Country
United States
Facility Name
Valeant Site 33
City
Los Angeles
State/Province
California
ZIP/Postal Code
90001
Country
United States
Facility Name
Valeant Site 43
City
Los Angeles
State/Province
California
ZIP/Postal Code
90002
Country
United States
Facility Name
Valeant Site 45
City
Sacramento
State/Province
California
ZIP/Postal Code
94203
Country
United States
Facility Name
Valeant Site 25
City
San Diego
State/Province
California
ZIP/Postal Code
92093
Country
United States
Facility Name
Valeant Site 4
City
San Diego
State/Province
California
ZIP/Postal Code
92093
Country
United States
Facility Name
Valeant Site 44
City
Santa Monica
State/Province
California
ZIP/Postal Code
90401
Country
United States
Facility Name
Valeant Site 36
City
Santa Rosa
State/Province
California
ZIP/Postal Code
95401
Country
United States
Facility Name
Valeant Site 10
City
Englewood
State/Province
Colorado
ZIP/Postal Code
80113
Country
United States
Facility Name
Valeant Site 3
City
Boynton Beach
State/Province
Florida
ZIP/Postal Code
33424
Country
United States
Facility Name
Valeant Site 28
City
Coral Gables
State/Province
Florida
ZIP/Postal Code
33134
Country
United States
Facility Name
Valeant Site 1
City
Miami
State/Province
Florida
ZIP/Postal Code
33101
Country
United States
Facility Name
Valeant Site 37
City
North Miami Beach
State/Province
Florida
ZIP/Postal Code
33160
Country
United States
Facility Name
Valeant Site 13
City
Sanford
State/Province
Florida
ZIP/Postal Code
32771
Country
United States
Facility Name
Valeant Site 41
City
Snellville
State/Province
Georgia
ZIP/Postal Code
30039
Country
United States
Facility Name
Valeant Site 17
City
South Bend
State/Province
Indiana
ZIP/Postal Code
46601
Country
United States
Facility Name
Valeant Site 12
City
Olathe
State/Province
Kansas
ZIP/Postal Code
66051
Country
United States
Facility Name
Valeant Site 19
City
Louisville
State/Province
Kentucky
ZIP/Postal Code
40201
Country
United States
Facility Name
Valeant Site 14
City
Louisville
State/Province
Kentucky
ZIP/Postal Code
40205
Country
United States
Facility Name
Valeant Site 35
City
Clinton Township
State/Province
Michigan
ZIP/Postal Code
48036
Country
United States
Facility Name
Valeant Site 34
City
Detroit
State/Province
Michigan
ZIP/Postal Code
48201
Country
United States
Facility Name
Valeant Site 16
City
Warren
State/Province
Michigan
ZIP/Postal Code
48088
Country
United States
Facility Name
Valeant Site 18
City
Fridley
State/Province
Minnesota
ZIP/Postal Code
55421
Country
United States
Facility Name
Valeant Site 31
City
Omaha
State/Province
Nebraska
ZIP/Postal Code
68022
Country
United States
Facility Name
Valeant Site 2
City
East Windsor
State/Province
New Jersey
ZIP/Postal Code
08520
Country
United States
Facility Name
Valeant Site 29
City
New York
State/Province
New York
ZIP/Postal Code
10001
Country
United States
Facility Name
Valeant Site 39
City
Rochester
State/Province
New York
ZIP/Postal Code
14603
Country
United States
Facility Name
Valeant Site 5
City
Portland
State/Province
Oregon
ZIP/Postal Code
97201
Country
United States
Facility Name
Valeant Site 11
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19019
Country
United States
Facility Name
Valeant Site 30
City
Charleston
State/Province
South Carolina
ZIP/Postal Code
29401
Country
United States
Facility Name
Valeant Site 15
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37115
Country
United States
Facility Name
Valeant Site 9
City
Dallas
State/Province
Texas
ZIP/Postal Code
75201
Country
United States
Facility Name
Valeant Site 40
City
Houston
State/Province
Texas
ZIP/Postal Code
77001
Country
United States
Facility Name
Valeant Site 8
City
Houston
State/Province
Texas
ZIP/Postal Code
77004
Country
United States
Facility Name
Valeant Site 46
City
Katy
State/Province
Texas
ZIP/Postal Code
77449
Country
United States
Facility Name
Valeant Site 20
City
Pflugerville
State/Province
Texas
ZIP/Postal Code
78660
Country
United States
Facility Name
Valeant Site 21
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78201
Country
United States
Facility Name
Valeant Site 7
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78202
Country
United States
Facility Name
Valeant Site 22
City
Webster
State/Province
Texas
ZIP/Postal Code
77598
Country
United States
Facility Name
Valeant Site 38
City
Salt Lake City
State/Province
Utah
ZIP/Postal Code
84101
Country
United States
Facility Name
Valeant Site 23
City
Lynchburg
State/Province
Virginia
ZIP/Postal Code
24501
Country
United States
Facility Name
Valeant Site 26
City
Norfolk
State/Province
Virginia
ZIP/Postal Code
23501
Country
United States
Facility Name
Valeant Site 42
City
Spokane
State/Province
Washington
ZIP/Postal Code
99201
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Long-Term Safety of IDP-118 Lotion in the Treatment of Plaque Psoriasis
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