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

Официальное название

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

Обзор

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.

Вмешательства

• Препарат IDP-122 Lotion
  Topical

Первичные конечные точки

• Pharmacokinetics: Maximum Observed Drug (Halobetasol Propionate) Concentration in Plasma (Cmax) of IDP-122 Lotion Analytes [Срок оценки: 0 (predose), 1, 2, 4, 8, 12, and 24 hours postdose]

Вторичные конечные точки (1)

• Proportion of Participants With Hypothalamic-Pituitary-Adrenal (HPA) Axis Suppression [Срок оценки: Week 8]

Критерии участия

Критерии включения

• 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.

Критерии исключения

• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Не применимо

Модель

Одна группа

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

США · 7 центров

• 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 центр

• Bausch Site 12 — Santo Domingo

Panama · 1 центр

• Bausch Site 4 — Panama City

Идентификаторы

NCT: NCT03987763 · V01-122A-401

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗