A Study to Evaluate the Safety and Clinical Performance of a Dexpanthenol Medicated Hydrogel Patch in the Treatment of Standardized Superficial Abrasions

Официальное название

A Randomized, Single-Blind, Intra-Individual Controlled Study to Evaluate the Safety and Clinical Performance of a Dexpanthenol Medicated Hydrogel Patch in the Treatment of Standardized Superficial Abrasions

Обзор

Clinical evaluation of a Dexpanthenol-medicated wound plaster on standardized superficial skin abrasions

Подробное описание

By utilizing a standardized abrasion model (based on the Wigger-Alberti methodology), the study aims to quantify the superior clinical performance of the Plaster compared to a standard plaster (conventional dry) and dry healing (no plaster). This evidence is crucial to demonstrate that the presence of Dexpanthenol provides a significant clinical benefit in terms of healing speed and aesthetic quality of the repaired tissue.

Вмешательства

• Устройство hydrogel plaster with dexpanthenol
  On the wound will be applied daily an hydrogel plaster with Dexpanthenol
• Устройство Standard plaster
  On the wound will be daily applicated a standard plaster on the market

Первичные конечные точки

• Re-epithelialization Rate [Срок оценки: day 5 day 7 day 15]

Вторичные конечные точки (4)

• Kinetics of Wound Closure [Срок оценки: Day 5 day 7]
• Subject-Reported Pain [Срок оценки: day 5 day 7]
• Scar Quality Assessment [Срок оценки: day 5 day 7 day 15]
• general usability [Срок оценки: Day 1, day 5, day 7]

Критерии участия

Критерии включения

• Healthy male or female volunteers aged 18 to 64 years (inclusive).
• Informed consent form signed voluntarily before any study-related procedure.
• Subjects willing and able to comply with all study protocol requirements, including scheduled visits and home-wear restrictions.
• Intact, healthy skin on both volar forearms (free of tattoos, scars, sunburns, or active skin lesions in the designated test areas).
• Agree to take precautions to prevent pregnancy (applicable only to non-menopausal women), including abstinence, intrauterine devices (IUDs), progestogen implants, combined estrogenic-progestogen contraceptives, the use of condoms;

Критерии исключения

• Known hypersensitivity or allergy to Dexpanthenol, hydrogel components, acrylic adhesives, or any component of the investigational devices.
• History of keloid formation, hypertrophic scarring, or abnormal wound healing.
• Active dermatological conditions (e.g., psoriasis, eczema, atopic dermatitis, active infections) on the upper extremities.
• History of diabetes mellitus, peripheral vascular disease, or arterial/venous microangiopathy.
• Systemic treatment with corticosteroids, immunosuppressive drugs, Anticoagulants, antiplatelet agents or cytostatic agents within 4 weeks prior to Baseline, or anticipated need during the study.
• Topical treatment (steroids, retinoids, antibiotics, or moisturizers) applied to the volar forearms within 2 weeks prior to Baseline.
• Active heavy smokers (more than 10 cigarettes per day) or users of nicotine-replacement therapies (nicotine alters cutaneous microcirculation and significantly impairs wound healing kinetics)
• Pregnant or lactating women, or women of childbearing potential not using highly effective contraception (see inclusion criteria).
• Not willing and able to comply with all study protocol requirements

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

Здоровые добровольцы: Да

Дизайн исследования

Распределение

Рандомизированное

Модель

Одна группа

Маскирование

Простое слепое

Основная цель

Поддерживающая терапия

Центры проведения

Италия · 1 центр

• la U.O.C. Anestesia Rianimazione degli Ospedali Riuniti Padova Sud — Monselice

Идентификаторы

NCT: NCT07642973 · MD03/26/WOOSH/DEX

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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