Back to resultsTopically Applied IDP-118 Lotion and HP Monad Lotion in Subjects With Moderate to Severe Plaque Psoriasis
Primary Purpose
Psoriasis
Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
IDP-118 Lotion
HP Monad Lotion
Ultravate Cream
Tazorac Cream
Sponsored by
About this trial
This is an interventional treatment trial for Psoriasis
Eligibility Criteria
Inclusion Criteria:
- Male or Female of any race, at least 18 years old of age (inclusive)
- Freely provides both written and oral informed consent.
- Has a clinical diagnosis of psoriasis at the Baseline visit with an Investigator's Global Assessment Score of 3 or 4. The face, scalp ,axillae, and intertriginous areas are to be excluded in this calculation.
- Has an area of plaque psoriasis for topical treatment that involves a BSA of at least 20%.
- The willing and able to avoid prolonged exposure of the treatment area to ultraviolet radiation (natural and artificial) for the duration of the study.
Key Exclusion Criteria:
- Has spontaneously improving or rapidly deteriorating plaque psoriasis or postural psoriasis, as determined by the investigator.
- Presents with psoriasis that was treated with prescription medication and failed to respond to presents).
- Has a history of adrenal disease.
- Presents with any other concurrent skin conditions that could interfere with the evaluation of the treatment areas, as determined by the investigator.
- Is pregnant, nursing, or planning pregnancy during the study period.
Sites / Locations
- Valeant Site 12
- Valeant Site 05
- Valeant Site 01
- Valeant Site 07
- Valeant Site 10
- Valeant Site 09
- Valeant Site 08
- Valeant Site 04
- Valeant Site 06
- Valeant Site 11
- Valeant Site 03
- Valeant Site 02
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm Type
Experimental
Experimental
Active Comparator
Active Comparator
Arm Label
IDP-118 Lotion
HP Monad Lotion
Ultravate Cream
Tazorac Cream
Arm Description
8 Weeks
8 Weeks
2 Weeks
4 Weeks
Outcomes
Primary Outcome Measures
Local Skin Reactions (LSRs)
Tolerability will be evaluated through assessment of local signs and symptoms (itching, dryness, burning/stinging) on a scale of non, mild, moderate, and severe.
Secondary Outcome Measures
Full Information
NCT ID
NCT03058744
First Posted
December 21, 2016
Last Updated
June 8, 2017
Sponsor
Bausch Health Americas, Inc.
1. Study Identification
Unique Protocol Identification Number
NCT03058744
Brief Title
Topically Applied IDP-118 Lotion and HP Monad Lotion in Subjects With Moderate to Severe Plaque Psoriasis
Official Title
A Phase 1b Open Label, Randomized Study Evaluating the Absorption and Systemic Pharmacokinetics and HPA Axis Suppression Potential of Topically Applied IDP-118 Lotion and HP Monad Lotion in Subjects With Moderate to Severe Plaque Psoriasis
Study Type
Interventional
2. Study Status
Record Verification Date
June 2017
Overall Recruitment Status
Completed
Study Start Date
April 2015 (Actual)
Primary Completion Date
December 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
No
5. Study Description
Brief Summary
Suppression Potential of Topically Applied IDP-118 Lotion and HP Monad Lotion in Subjects with Moderate to Severe Plaque Psoriasis.
Detailed Description
A Phase 1b Open-Label, Randomized Study Evaluating the Absorption and Systemic Pharmacokinetics and HPA Axis Suppression Potential of Topically Applied IDP-118 Lotion and HP Monad Lotion in Subjects with Moderate to Severe 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 1
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
94 (Actual)
8. Arms, Groups, and Interventions
Arm Title
IDP-118 Lotion
Arm Type
Experimental
Arm Description
8 Weeks
Arm Title
HP Monad Lotion
Arm Type
Experimental
Arm Description
8 Weeks
Arm Title
Ultravate Cream
Arm Type
Active Comparator
Arm Description
2 Weeks
Arm Title
Tazorac Cream
Arm Type
Active Comparator
Arm Description
4 Weeks
Intervention Type
Drug
Intervention Name(s)
IDP-118 Lotion
Other Intervention Name(s)
Lotion
Intervention Description
Lotion
Intervention Type
Drug
Intervention Name(s)
HP Monad 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
Intervention Type
Drug
Intervention Name(s)
Tazorac Cream
Other Intervention Name(s)
Taz
Intervention Description
Cream
Primary Outcome Measure Information:
Title
Local Skin Reactions (LSRs)
Description
Tolerability will be evaluated through assessment of local signs and symptoms (itching, dryness, burning/stinging) on a scale of non, mild, moderate, and severe.
Time Frame
8 Weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Male or Female of any race, at least 18 years old of age (inclusive)
Freely provides both written and oral informed consent.
Has a clinical diagnosis of psoriasis at the Baseline visit with an Investigator's Global Assessment Score of 3 or 4. The face, scalp ,axillae, and intertriginous areas are to be excluded in this calculation.
Has an area of plaque psoriasis for topical treatment that involves a BSA of at least 20%.
The willing and able to avoid prolonged exposure of the treatment area to ultraviolet radiation (natural and artificial) for the duration of the study.
Key Exclusion Criteria:
Has spontaneously improving or rapidly deteriorating plaque psoriasis or postural psoriasis, as determined by the investigator.
Presents with psoriasis that was treated with prescription medication and failed to respond to presents).
Has a history of adrenal disease.
Presents with any other concurrent skin conditions that could interfere with the evaluation of the treatment areas, as determined by the investigator.
Is pregnant, nursing, or planning pregnancy during the study period.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Lindsey Mathew
Organizational Affiliation
Valeant Pharmaceuticals
Official's Role
Study Director
Facility Information:
Facility Name
Valeant Site 12
City
Anaheim
State/Province
California
ZIP/Postal Code
92801
Country
United States
Facility Name
Valeant Site 05
City
Encino
State/Province
California
ZIP/Postal Code
91436
Country
United States
Facility Name
Valeant Site 01
City
San Diego
State/Province
California
ZIP/Postal Code
92093
Country
United States
Facility Name
Valeant Site 07
City
Santa Rosa
State/Province
California
ZIP/Postal Code
95401
Country
United States
Facility Name
Valeant Site 10
City
Orange Park
State/Province
Florida
ZIP/Postal Code
32065
Country
United States
Facility Name
Valeant Site 09
City
Sanford
State/Province
Florida
ZIP/Postal Code
32771
Country
United States
Facility Name
Valeant Site 08
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30301
Country
United States
Facility Name
Valeant Site 04
City
Plainfield
State/Province
Indiana
ZIP/Postal Code
46168
Country
United States
Facility Name
Valeant Site 06
City
New York
State/Province
New York
ZIP/Postal Code
10001
Country
United States
Facility Name
Valeant Site 11
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19019
Country
United States
Facility Name
Valeant Site 03
City
Austin
State/Province
Texas
ZIP/Postal Code
73301
Country
United States
Facility Name
Valeant Site 02
City
Katy
State/Province
Texas
ZIP/Postal Code
77449
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
Yes
Learn more about this trial
Topically Applied IDP-118 Lotion and HP Monad Lotion in Subjects With Moderate to Severe Plaque Psoriasis
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