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Not yet recruiting NCT07642973

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

No phase Interventional Skin Wounds Abrasion

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: hydrogel plaster with dexpanthenol, Standard plaster.
Who it may be relevant to
Registry conditions: Skin Wounds, Abrasion. Basic parameters: 18 years — 64 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Italy
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

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

Overview

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

Detailed description

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.

Interventions

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

Primary outcome measures

  • Re-epithelialization Rate [Time frame: day 5 day 7 day 15]
Secondary outcome measures (4)
  • Kinetics of Wound Closure [Time frame: Day 5 day 7]
  • Subject-Reported Pain [Time frame: day 5 day 7]
  • Scar Quality Assessment [Time frame: day 5 day 7 day 15]
  • general usability [Time frame: Day 1, day 5, day 7]

Eligibility criteria

Inclusion criteria

  • 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;

Exclusion criteria

  • 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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation
Randomized
Model
Single group
Masking
Single blind
Primary purpose
Supportive care

Study locations

Italy · 1 center
  • la U.O.C. Anestesia Rianimazione degli Ospedali Riuniti Padova Sud — Monselice

Identifiers

NCT: NCT07642973 · MD03/26/WOOSH/DEX

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗