Plaque PsoriasisPhase 3NCT02462122
Safety and Efficacy of IDP-118 in Participants With Plaque Psoriasis
A Phase 3 study testing IDP-118 Lotion in people with Plaque Psoriasis, run by Bausch Health Americas, Inc. at 16 sites in United States.
Trial summary
Safety and Efficacy of IDP-118 in the treatment of plaque psoriasis Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Plaque Psoriasis
- What is being tested?
- IDP-118 Lotion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 215 participants
- Where
- 16 sitesUnited States
- Study dates
- 19 Aug 2015to 14 Nov 2016
- Phase
- Phase 3
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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).
Who cannot join
- 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.
Trial locations and contacts
16 sites in 1 country.
16 sites in 1 country
United States16 sites
Valeant Site 4
Albuquerque, New Mexico, 87103
Valeant Site 2
Boynton Beach, Florida, 33424
Valeant Site 9
College Station, Texas, 77840
Valeant Site 13
Detriot, Michigan, 48201
Valeant Site 1
East Windsor, New Jersey, 08520
Valeant Site 5
Fremont, California, 94536
Valeant Site 10
Fridley, Minnesota, 55421
Valeant Site 6
High Point, North Carolina, 27260
Valeant Site 15
Houston, Texas, 77001
Valeant Site 16
Houston, Texas, 77001
Valeant Site 7
Knoxville, Tennessee, 37909
Valeant Site 12
New York, New York, 10001
Valeant Site 14
North Miami Beach, Florida, 33160
Valeant Site 11
Pflugerville, Texas, 78660
Valeant Site 3
Portland, Oregon, 97201
Valeant Site 8
Warren, Michigan, 48088
About this study
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
Safety and Efficacy of IDP-118 in the treatment of plaque psoriasis
Read the 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
- Conditions
- Plaque Psoriasis
- Being tested
- IDP-118 Lotion, IDP-118 Vehicle Lotion
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
IDP-118 LotionDrug
Also called Lotion
Lotion
IDP-118 Vehicle LotionDrug
Also called Vehicle
Lotion
| Study group | Role | What they receive |
|---|---|---|
| IDP-118 Lotion | Experimental | Lotion Receives: Drug: IDP-118 Lotion |
| IDP-118 Vehicle Lotion | Active comparator | Vehicle Lotion Receives: Drug: IDP-118 Vehicle Lotion |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 8 weeks
Secondary outcomes (1)
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.
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jun 2015 (estimated)
- Study start19 Aug 2015
- Primary completion9 Nov 2016
- Study completion14 Nov 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Plaque PsoriasisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 215 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bausch Health Americas, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Dow Pharmaceutical Sciences
- Responsible party
- Sponsor
- Investigators
- Binu J Alexander, MD, Study director, Valeant Pharmaceuticals
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02462122
- Sponsor's protocol ID
- V01-118A-302
- Status last verified
- Aug 2020
- First submitted
- 1 Jun 2015
- Last updated
- 20 Oct 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Individual data sharing
- Undecided