Идёт набор NCT07265479

A Study to Investigate Safety and Efficacy of Tapinarof Cream, 1% in Participants Ages 3 Months to < 24 Months With Atopic Dermatitis

Фаза III С лечением Atopic Dermatitis

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают: В протоколе указаны: Tapinarof cream, 1%, Vehicle Cream.
Кому может быть актуально: Состояния в реестре: Atopic Dermatitis. Базовые параметры: 3 мес. — 23 мес. · Все.
Что важно проверить: Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится: США, Канада
Следующий шаг: Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →

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Официальное название

A Randomized, Double-Blind, Vehicle-Controlled (Period 1) and Open-Label (Period 2) Phase 3 Study to Investigate the Safety and Efficacy of Tapinarof Cream, 1% in Pediatric Participants Ages 3 Months to < 24 Months With Atopic Dermatitis

Обзор

The purpose of this global Phase 3 clinical study is to investigate the safety and efficacy of tapinarof cream, 1% in participants ages 3 months to 23 months (inclusive) with atopic dermatitis.

Вмешательства

Препарат Tapinarof cream, 1%
Tapinarof cream, 1%: Applied topically once daily to lesions on participant's skin during the Double-Blind period. During the Open-Label Period, it will be applied once daily to lesions, as needed.
Препарат Vehicle Cream
Applied topically once daily to lesions on participant's skin during the Double-Blind period.

Первичные конечные точки

Percentage of participants who have a validated Investigator Global Assessment for Atopic Dermatitis (vIGA-AD) score of clear or almost clear (0 or 1) and a minimum 2-grade Improvement from Baseline to Week 8 [Срок оценки: Baseline to last planned visit in the Double-Blind Period, up to 8 weeks.]
Percentage of participants who enter with or achieve have a validated Investigator Global Assessment for Atopic Dermatitis (vIGA-AD) score of clear or almost clear (0 or 1) and a minimum 2-grade Improvement at least once during the Open-Label Period [Срок оценки: Baseline to the end of the Open-Label Period, up to 56 weeks.]

Вторичные конечные точки (11)

Percentage of participants with ≥ 75% improvement in Eczema Area and Severity Index (EASI) Score from Baseline to Week 8. [Срок оценки: Baseline to last planned visit in the Double-Blind Period, up to 8 weeks.]
Mean change in percentage of total body surface area (%BSA) affected from Baseline to Week 8 [Срок оценки: Baseline to last planned visit in the Double-Blind Period, up to 8 weeks.]
Percentage of participants with ≥ 90% improvement in Eczema Area and Severity Index (EASI) score from Baseline to Week 8 [Срок оценки: Baseline to last planned visit in the Double-Blind Period, up to 8 weeks.]
Number of participants with one or more Treatment Emergent Adverse Events (TEAEs) [Срок оценки: Baseline to last planned visit in the Double-Blind Period, up to 8 weeks]
Number of participants with one or more Treatment Emergent Adverse Events (TEAEs) [Срок оценки: Baseline to the end of the Open-Label Period, up to 56 weeks]
Percentage of participants with one or more Treatment Emergent Adverse Events (TEAEs) [Срок оценки: Baseline to last planned visit in the Double-Blind Period, up to 8 weeks .]
Percentage of participants with one or more Treatment Emergent Adverse Events (TEAEs) [Срок оценки: Baseline to the end of the Open-Label Period, up to 56 weeks.]
Investigator-assessed Local Tolerability Scale (LTS) scores by visit (overall) [Срок оценки: Baseline to last planned visit in the Double-Blind Period, up to 8 weeks]
Investigator-assessed Local Tolerability Scale (LTS) scores by visit (overall) [Срок оценки: Beginning of Open-Label to the end of the Open-Label Period, up to 48 weeks.]
Investigator-assessed Local Tolerability Scale (LTS) scores by visit (sensitive areas) [Срок оценки: Baseline to last planned visit in the Double-Blind Period, up to 8 weeks]
Investigator-assessed Local Tolerability Scale (LTS) scores by visit (sensitive areas) [Срок оценки: Beginning of Open-Label to the end of the Open-Label Period, up to 48 weeks.]

Критерии участия

Критерии включения

Infants and toddlers born at term (≥37 weeks of gestational age) that are 3 months to <24 months of age at the Screening visit.
Clinical diagnosis of atopic dermatitis (AD), AD covering >5% Body Surface Area (BSA) and validated Investigator Global Assessment for Atopic Dermatitis (vIGA-AD) score of 2, 3 or 4
Legal guardian or primary caregiver is willing and able to sign informed consent form before any study-related activities
Legal guardian or primary caregiver is able and willing to adhere to protocol requirements

Критерии исключения

Significant neurological disorder or history of seizure
Know clinically significant cardiac rhythm or cardiac disorder
History of sudden infant death in a sibling
Clinically significant chromosome abnormality
History of or ongoing serious illness or medical, physical or psychiatric condition(s) that may interfere with the participant's participation
Diseases that could cause pruritic and/or sleep disruption
Immunocompromised
Current chronic or acute infection requiring treatment
Use of prohibited medication(s) or procedure(s)
Use of prohibited medications by breastfeeding mother if breastfeeding participant

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

Здоровые добровольцы: Нет