Study to Assess Efficacy, Safety and Tolerability of a Nail Patch in Patients With Nail Fragility, Mychosis, Psoriasis

Официальное название

A Randomized, Double Blind, Placebo-controlled, Unicenter, Parallel Group Study to Assess the Efficacy, Safety and Tolerability of a Multi-funtion Toe Nail Patch in Patients Affected by Nail Fragility, Nail Mychosis and Psoriasis

Обзор

A randomized, double blind, placebo-controlled, unicenter, parallel group study to assess the efficacy, safety and tolerability of a multi-funtion toe nail patch in patients affected by nail fragility, nail mychosis and psoriasis 72 patients in 6 subgroups Treatment duration 3 months + 1 month follow-up

Подробное описание

A randomized, double blind, placebo-controlled, mono center, parallel group study.

72 Eligible patients will receive Hydrogel Nail Patch every day for three months, in the evening. All the patients will be characterized according to the percentage of target nail involvement (defined as either 50% or 51-75).

Patients applied their allocated treatment to the surface of all affected nails, in particular Hydrogel Nail Patch or Placebo will be applied topically in the evening at bedtime and taken away in the morning, every day for 12 (twelve)weeks. The subjects will receive a visit by the Clinical Investigator after 4 weeks from the end of treatments.

A single affected nail with Fragility nail or onychomycosis or nail psoriasis will be identified as the target nail for all assessments. Target nails had to fulfil the study's inclusion and exclusion criteria and the presence of nail pathology confirmed by Score Index test, photographic documentation, physician judgement. Patients will attend visits at screening(V0), baseline (V1), and at weeks 3(V2), 6(V3), 9(V4) and 12(V5).

The Multi-Function Toe Nail Patch and the Placebo will be applied topically on the big toe affected by nail pathology, according to their characteristics.

Вмешательства

• Другое Cosmetic patch containing urea applicated daily for 3 months
  Daily application of the patch on toes, 3 months treatment
• Другое Placebo patch application
  Daily application of a placebo patch on toes for a 3 months treatment

Первичные конечные точки

• Evaluation, based on adverse events numeber of the Multi-Function Hydrogel Nail Patch safety in adult humans affected by Fragility Nails, Onychomycosis and Nail Psoriasis [Срок оценки: From the enrollment day (visit 1) to the follow-up visit after 4 months]

Вторичные конечные точки (1)

• Efficacy of the patch, measuring the size of the nail patology [Срок оценки: From enrollment day (visit 1) to the follow-up visit after 4 months]

Критерии участия

Критерии включения

• aged 18 years or older Fragility Nails Distal Subungual Onychomycosis Nail Psoriasis affecting ≤75% of the nail bed according to a photographic documentation and to a subjective evaluation by the Investigator.

Критерии исключения

• Patients that have proximal subungual onychomycosis, if their distal subungual onychomycosis is extended into the proximal portion of the nail or if it affects >75% of the nail.
• Patients with conditions known to cause abnormal nail appearance, immunosuppression and signs of severe peripheral circulatory insufficiency
• Patients who had used topical antifungal, anti-psoriasis nail treatment within one month or systemic antifungal treatment within three months.
• Patients who have participated in another clinical nail study during the previous three months
• Patients who have a known allergy to any of the study treatments.
• Patients with unrelated nail disorders: onychomycosis, nail psoriasis, genetically induced onychodystrophy.
• Patients with other nail disorders, active or severe psoriasis elsewhere, other autoimmune or inflammatory diseases.

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

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Простое слепое

Основная цель

Лечение

Центры проведения

Италия · 1 центр

• Clinica Dermatologica - Policlinico - Università degli Studi di Milano Via Francesco Sforz — Milan

Идентификаторы

NCT: NCT07029516 · 2025/AFCV/WOOSHIN/MFP/PL

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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