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Phase 3 N=203 Randomized Quadruple-blind Treatment

Safety and Efficacy of IDP-118 in the Treatment of Plaque Psoriasis

Plaque Psoriasis

Enrolled (actual)
203
Serious AEs
1.5%
Results posted
Aug 2020
Primary outcome: Primary: The Percentage of Participants With Treatment Success at Week 8 — 35.76; 6.98 percentage of participants

Study Design & Population

Study type
Interventional
Phase
Phase 3
Interventions
IDP-118 Lotion (Drug); IDP-118 Vehicle Lotion (Drug)
Age
Adult, Older Adult · 18+ yrs
Sex
All
Sponsor
Bausch Health Americas, Inc.
Primary completion
Nov 2016

Outcome Measures

OutcomeResultp-value
PRIMARY
The Percentage of Participants With Treatment Success at Week 8
35.76; 6.98
SECONDARY
Percentage of Participants With Treatment Success at Weeks 12, 6, 4, and 2
33.25; 8.51; 37.84; 6.67; 24.86; 9.33

Summary

The objective of the study is to evaluate the safety and efficacy of a topical lotion.

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 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).

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.
View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT02462070). 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.

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