Phase 3
N=213
Safety and Efficacy of IDP-122 in the Treatment of Participants With Plaque Psoriasis
Plaque Psoriasis
Bottom Line
View on ClinicalTrials.gov: NCT02515097 ↗Enrolled (actual)
213
Serious AEs
1.4%
Results posted
Jan 2020
Primary outcome: Primary: Percentage of Participants With Treatment Success at Week 8 — 38.41; 11.99 percentage of participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- IDP-122 Lotion (Drug); IDP-122 Vehicle Lotion (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Bausch Health Americas, Inc.
- Primary completion
- Mar 2017
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Participants With Treatment Success at Week 8 |
38.41; 11.99 | — |
| SECONDARY Percentage of Participants With Treatment Success at Weeks 2, 4, 6, and 12 |
4.93; 0.00; 19.26; 0.20; 27.71; 4.35 | — |
Summary
This study is to evaluate the safety and efficacy of a topical lotion when applied once daily to adult participants with moderate to severe plaque psoriasis (defined as an Investigator's Global Assessment [IGA] score of 3 or 4).
Eligibility Criteria
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%, 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).
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.
Data sourced from ClinicalTrials.gov (NCT02515097). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.