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Recruiting NCT03987763

A Safety and Pharmacokinetics Study of IDP-122 Lotion in Pediatric Participants With Plaque Psoriasis

Phase IV Interventional Psoriasis

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: IDP-122 Lotion.
Who it may be relevant to
Registry conditions: Psoriasis. Basic parameters: 6 years — 17 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States, Dominican Republic, Panama
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

A Phase 4, Open-Label, Multicenter Study Evaluating the Absorption and Systemic Pharmacokinetics and HPA Axis Suppression Potential of Topically Applied IDP-122 Lotion in Pediatric Subjects With Moderate to Severe Plaque Psoriasis

Overview

This study is to evaluate the safety, the systemic exposure of halobetasol propionate (HP), and the hypothalamic-pituitary-adrenal (HPA) axis suppression potential for topically applied IDP-122 lotion in pediatric participants with moderate to severe plaque psoriasis.

Interventions

  • Drug IDP-122 Lotion
    Topical

Primary outcome measures

  • Pharmacokinetics: Maximum Observed Drug (Halobetasol Propionate) Concentration in Plasma (Cmax) of IDP-122 Lotion Analytes [Time frame: 0 (predose), 1, 2, 4, 8, 12, and 24 hours postdose]
Secondary outcome measures (1)
  • Proportion of Participants With Hypothalamic-Pituitary-Adrenal (HPA) Axis Suppression [Time frame: Week 8]

Eligibility criteria

Inclusion criteria

  • Is 6 to 16 years 11 months of age at time of informed consent/assent obtained.
  • Verbal and written informed consent/assent obtained from the participant and/or parent or legal guardian.
  • Has a clinical diagnosis of psoriasis at Screening and Baseline with an Investigator's Global Assessment (IGA) score of 3 or 4. The face, scalp, axillae, and intertriginous areas are to be excluded in this assessment, if psoriasis is present.
  • Has an area of plaque psoriasis appropriate for topical treatment that involves a BSA of at least 10% at Screening and Baseline. The face, scalp, 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.
  • Is in good general adrenal health, as determined by a 30-minute postcosyntropin stimulation serum cortisol level that is >18 μg/dL at the Screening visit.
  • Females of childbearing potential and females who are pre-menses (9 years and older) must be willing to practice effective contraception for the duration of the study.

Exclusion criteria

  • Has a history of adrenal disease.
  • 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 baseline or is concurrently participating in another clinical study with an investigational drug or device.
  • Received treatment with a topical antipsoriatic drug product other than corticosteroids within 14 days prior to the Baseline visit and/or treatment containing corticosteroids within 28 days prior to the screening HPA axis stimulation test.
  • Has a history of hypersensitivity or allergic reaction to any of the study drug constituents.
  • Is considered by the Investigator, for any other reason, to be an unsuitable candidate for the study.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
N/A
Model
Single group
Masking
Open label
Primary purpose
Treatment

Study locations

United States · 7 centers
  • Bausch Site 11 — Fountain Valley
  • Bausch Site 2 — Thousand Oaks
  • Bausch Site 07 — Doral
  • Bausch Site 3 — Miami
  • Bausch Site 06 — Miami
  • Bausch Site 05 — Spartanburg
  • Bausch Site 1 — Spokane
Dominican Republic · 1 center
  • Bausch Site 12 — Santo Domingo
Panama · 1 center
  • Bausch Site 4 — Panama City

Identifiers

NCT: NCT03987763 · V01-122A-401

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗