Safety and Efficacy of IDP-118 in the Treatment of Plaque Psoriasis
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
1 other identifier
interventional
203
1 country
16
Brief Summary
The objective of the study is to evaluate the safety and efficacy of a topical lotion.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_3
Started Aug 2015
Shorter than P25 for phase_3
16 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 1, 2015
CompletedFirst Posted
Study publicly available on registry
June 3, 2015
CompletedStudy Start
First participant enrolled
August 11, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 8, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2016
CompletedResults Posted
Study results publicly available
August 20, 2020
CompletedAugust 20, 2020
August 1, 2020
1.2 years
June 1, 2015
August 8, 2020
August 8, 2020
Conditions
Outcome Measures
Primary Outcomes (1)
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.
8 weeks
Secondary Outcomes (1)
Percentage of Participants With Treatment Success at Weeks 12, 6, 4, and 2
12 weeks
Study Arms (2)
IDP-118 Lotion
EXPERIMENTALLotion
IDP-118 Vehicle Lotion
ACTIVE COMPARATORVehicle Lotion
Interventions
Eligibility Criteria
You may qualify if:
- 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).
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Bausch Health Americas, Inc.lead
- Dow Pharmaceutical Sciencescollaborator
Study Sites (16)
Valeant Site 3
Mobile, Alabama, 36601, United States
Valeant Site 9
Beverly Hills, California, 90210, United States
Valeant Site 12
Encino, California, 91316, United States
Valeant Site 10
San Diego, California, 92093, United States
Valeant Site 1
Santa Rosa, California, 95403, United States
Valeant Site 16
Denver, Colorado, 80123, United States
Valeant Site 2
Tampa, Florida, 33601, United States
Valeant Site 7
South Bend, Indiana, 46601, United States
Valeant Site 8
Louisville, Kentucky, 40202, United States
Valeant Site 13
Clinton Township, Michigan, 48036, United States
Valeant Site 14
Rochester, New York, 14603, United States
Valeant Site 6
Nashville, Tennessee, 37115, United States
Valeant Site 5
Austin, Texas, 73344, United States
Valeant Site 4
Houston, Texas, 77001, United States
Valeant Site 11
Norfolk, Virginia, 23501, United States
Valeant Site 15
Spokane, Washington, 99201, United States
Results Point of Contact
- Title
- Study Director
- Organization
- Bausch Health
Study Officials
- STUDY DIRECTOR
Binu J Alexander
Valeant Pharmaceuticals
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 1, 2015
First Posted
June 3, 2015
Study Start
August 11, 2015
Primary Completion
November 8, 2016
Study Completion
December 1, 2016
Last Updated
August 20, 2020
Results First Posted
August 20, 2020
Record last verified: 2020-08