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Phase 3 Completed N=555 Treatment

Long-Term Safety of IDP-118 Lotion in the Treatment of Plaque Psoriasis

Source: ClinicalTrials.gov NCT02462083 ↗
Enrolled (actual)
555
Serious AEs
3.3%
Results posted
Jan 2020
Primary outcomePrimary: Percentage of Participants Who Experienced Grade 3 Local Skin Reactions — 22.2; 6.9; 9.8 percentage of participants
◆ Published Evidence
No publication linked

No peer-reviewed publication reporting this trial's results has been linked yet. This can indicate results are unpublished — a known publication-bias signal. We re-check periodically.

Summary

The objective of this study is to evaluate the long-term safety of IDP-118 lotion.

Outcome Measures

OutcomeResultp-value
PRIMARY
Percentage of Participants Who Experienced Grade 3 Local Skin Reactions
22.2; 6.9; 9.8

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 Body Surface Area (BSA) of at least 3 percent (%), 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 Investigators Global Assessment (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 (NCT02462083). 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. Informational only — not medical advice.

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