Clinical Study on the Medical Devices PROXERA PSOMED 20 and PROXERA PSOMED 40 for the Treatment of Plaque Psoriasis and Non-pustular Palmoplantar Psoriasis

Официальное название

Evaluation of the Efficacy and Safety of the Medical Device PROXERA PSOMED 20 in Reducing Psoriatic Plaques and of the Medical Device PROXERA PSOMED 40 in Reducing Non-pustulous Palmoplantar Psoriasis Flaw in Patients With Plaque Psoriasis: a Sponsored, Interventional, Single-center, Randomized, Single-blind, Intra-patient Controlled Study (PASI)

Обзор

This single-center interventional study was designed to evaluate the efficacy and safety of two CE-marked topical medical devices: PROXERA PSOMED 20 is being studied in participants with non-palmoplantar plaque psoriasis, while PROXERA PSOMED 40 is being studied in participants with non-pustular palmoplantar psoriasis. The study aims to determine whether treating a target area with the assigned medical device leads to greater clinical improvement compared to the untreated contralateral control area in the same participant. For PROXERA PSOMED 20, the primary assessment is performed after 4 weeks of treatment. For PROXERA PSOMED 40, the primary assessment is performed after 8 weeks of treatment. Secondary objectives include the assessment of safety, local tolerability, overall psoriasis progress, its impact on quality of life, and additional parameters of local disease activity at the target areas. Participants will apply the assigned study device once daily to the selected target area, undergo clinical assessments at scheduled visits, and provide safety and tolerability information throughout the study.

Вмешательства

• Устройство PROXERA PSOMED 20 cream; PROXERA PSOMED 40 gel
  Proxera Psomed 20: Topical medical device in cream formulation containing 20% urea, supplied in a 200 mL tube. It is self-applied by the participant once daily at the same time of day to the selected target plaque for 4 weeks, according to the fingertip unit rule. The contralateral comparable target area remains untreated as control. Proxera Psomed 40: Topical medical device in gel formulation containing 40% urea, supplied in a 100 mL tube. It is self-applied by the participant once daily at th

Первичные конечные точки

• Difference Between Treated and Untreated Target Plaques in Change From Baseline in Target Lesion Score at Week 4 [Срок оценки: Baseline to Week 4 (end of treatment)]
• Difference Between Treated and Untreated Target Areas in Change From Baseline in Local Modified Palmoplantar Psoriasis Area and Severity Index at Week 8 [Срок оценки: Baseline to Week 8 (end of treatment)]

Вторичные конечные точки (12)

• Difference Between Treated and Untreated Target Plaques in Change From Baseline in Target Lesion Score at Week 8 [Срок оценки: Baseline to Week 8 (4 weeks after the end of treatment)]
• Difference Between Treated and Untreated Target Areas in Change From Baseline in Local Modified Palmoplantar Psoriasis Area and Severity Index at Week 12 [Срок оценки: Baseline to Week 12 (4 weeks after the end of treatment)]
• Change From Baseline in Psoriasis Area and Severity Index Score at Week 4 in the PROXERA PSOMED 20 Cohort [Срок оценки: Baseline to Week 4 (end of treatment)]
• Change From Baseline in Psoriasis Area and Severity Index Score at Week 8 in the PROXERA PSOMED 40 Cohort [Срок оценки: Baseline to Week 8 (end of treatment)]
• Change From Baseline in Psoriasis Area and Severity Index Score at Week 8 in the PROXERA PSOMED 20 Cohort [Срок оценки: Baseline to Week 8 (4 weeks after the end of treatment)]
• Change From Baseline in Psoriasis Area and Severity Index Score at Week 12 in the PROXERA PSOMED 40 Cohort [Срок оценки: Baseline to Week 12 (4 weeks after the end of treatment)]
• Change From Baseline in Dermatology Life Quality Index Score at Week 4 in the PROXERA PSOMED 20 Cohort [Срок оценки: Baseline to Week 4 (end of treatment)]
• Change From Baseline in Dermatology Life Quality Index Score at Week 8 in the PROXERA PSOMED 40 Cohort [Срок оценки: Baseline to Week 8 (end of treatment)]
• Change From Baseline in Dermatology Life Quality Index Score at Week 8 in the PROXERA PSOMED 20 Cohort [Срок оценки: Baseline to Week 8 (4 weeks after the end of treatment)]
• Change From Baseline in Dermatology Life Quality Index Score at Week 12 in the PROXERA PSOMED 40 Cohort [Срок оценки: Baseline to Week 12 (4 weeks after the end of treatment)]
• Difference Between Treated and Untreated Target Plaques in Change From Baseline in Transepidermal Water Loss at Week 4 [Срок оценки: Baseline to Week 4 (end of treatment)]
• Difference Between Treated and Untreated Target Areas in Change From Baseline in Transepidermal Water Loss at Week 8 [Срок оценки: Baseline to Week 8 (end of treatment)]

Критерии участия

Критерии включения

PROXERA PSOMED 20 - normalizing cream, 20% urea

• Diagnosis of plaque psoriasis (not palmoplantar) for at least 1 year PROXERA PSOMED 40 - intensive exfoliating gel, 40% urea
• Diagnosis of non-pustular palmoplantar psoriasis for at least 1 year

Common inclusion criteria:

• Age 18-65 years
• "Mild" psoriasis severity according to:
• Psoriasis Area Severity Index (PASI) <10
• Dermatologic Life Quality Index (DLQI) <10
• Body Surface Area (BSA) <10

Критерии исключения

• Product intolerance
• Concomitant therapy with systemic immunomodulatory drugs (e.g., methotrexate, cyclosporine, apremilast)
• Concomitant therapy with biologic drugs such as anti-TNFα, anti-IL17, or anti-IL23.
• Concomitant topical therapy with topical corticosteroids (TCS), topical calcineurin inhibitors (TCI), vitamin D analogues, and combinations.
• Pregnant or breastfeeding women

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

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Нерандомизированное

Модель

Параллельные группы

Маскирование

Простое слепое

Основная цель

Лечение

Центры проведения

Италия · 1 центр

• Clinica Dermatologica Dipartimento di Medicina e Scienze dell'Invecchiamento Università G. — Chieti

Идентификаторы

NCT: NCT07545902 · Id 286

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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