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 (Dexpanthenol)

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

Study Overview

• Status: Not yet recruiting
• Conditions: Abrasion; Skin Wounds
• Intervention / Treatment: Device: hydrogel plaster with dexpanthenol; Device: Standard plaster

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.

• Study Type: Interventional
• Enrollment (Estimated): 40
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Adolfo Gasparetto, MD; Phone Number: +39 3356641965; Email: adolfogasparetto@nextrasearch.it
• Study Contact Backup: Name: Alessandro Guzzo, MD; Phone Number: +39 0429715610; Email: alessandro.guzzo@aulss6.veneto.it

Study Locations

• Italy
  • PD
    • Monselice, PD, Italy, 35043
      • la U.O.C. Anestesia Rianimazione degli Ospedali Riuniti Padova Sud
      • Contact: Alessandro Guzzo, MD; Phone Number: +39 0429714111; Email: alessandro.guzzo@aulss6.veneto.it
      • Principal Investigator: Alessandro Guzzo, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: Yes

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Single Group Assignment
• Masking: Single

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Dexpanthenol; On the wound will be applied an experimental Hydrogel plaster with Dexpanthenol	Device: hydrogel plaster with dexpanthenol; On the wound will be applied daily an hydrogel plaster with Dexpanthenol
Active Comparator: Standard plaster; On the wound will be applied a standard plaster, with no active ingredients	Device: Standard plaster; On the wound will be daily applicated a standard plaster on the market
No Intervention: No treatment; The wound is not covered or medicated

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Re-epithelialization Rate	Measured as the percentage of wound closure compared to baseline (T0) with standardized photography	day 5 day 7 day 15

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Kinetics of Wound Closure	Time to 50% re-epithelialization	Day 5 day 7
Subject-Reported Pain	Pain during wear and upon plaster removal assessed via a 100-mm Visual Analogue Scale (VAS)	day 5 day 7
Scar Quality Assessment	using the Vancouver Scar Scale (VSS) (scoring vascularity, pigmentation, pliability, and height)	day 5 day 7 day 15
general usability	Assessment of the plaster adherence to the perilesional skin over the treatment period using a 5-Point Adhesion Score 0 (100%) to 4 (0% fallen)	Day 1, day 5, day 7

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of AE	Safety outcome	from day 1 to day 15 (all the study duration)

Collaborators and Investigators

• Sponsor: Wooshin Labottach Co., Ltd.
• Collaborators: Nextrasearch S.r.l.s.
• Investigators: Principal Investigator: Alessandro Guzzo, MD, la U.O.C. Anestesia Rianimazione degli Ospedali Riuniti Padova Sud con indirizzo via Albere, 30 Monselice

Study record dates

Study Major Dates

• Study Start (Estimated): September 1, 2026
• Primary Completion (Estimated): October 1, 2026
• Study Completion (Estimated): December 1, 2026

Study Registration Dates

• First Submitted: June 3, 2026
• First Submitted That Met QC Criteria: June 8, 2026
• First Posted (Actual): June 11, 2026

Study Record Updates

• Last Update Posted (Actual): June 11, 2026
• Last Update Submitted That Met QC Criteria: June 8, 2026
• Last Verified: June 1, 2026

More Information

Terms related to this study

• Keywords: dexpanthenol; superficial wounds; plaster
• Other Study ID Numbers: MD03/26/WOOSH/DEX

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: When study will be closed and published
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ANALYTIC_CODE

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No