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)

June 8, 2026 updated by: Wooshin Labottach Co., Ltd.
Clinical evaluation of a Dexpanthenol-medicated wound plaster on standardized superficial skin abrasions

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Not yet recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
40

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

  • Italy
    • PD
      • Monselice, PD, Italy, 35043
        • la U.O.C. Anestesia Rianimazione degli Ospedali Riuniti Padova Sud
        • Contact:
        • Principal Investigator:
          • Alessandro Guzzo, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Re-epithelialization Rate
Time Frame: day 5 day 7 day 15
Measured as the percentage of wound closure compared to baseline (T0) with standardized photography
day 5 day 7 day 15

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Kinetics of Wound Closure
Time Frame: Day 5 day 7
Time to 50% re-epithelialization
Day 5 day 7
Subject-Reported Pain
Time Frame: day 5 day 7
Pain during wear and upon plaster removal assessed via a 100-mm Visual Analogue Scale (VAS)
day 5 day 7
Scar Quality Assessment
Time Frame: day 5 day 7 day 15
using the Vancouver Scar Scale (VSS) (scoring vascularity, pigmentation, pliability, and height)
day 5 day 7 day 15
general usability
Time Frame: Day 1, day 5, day 7
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

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Number of AE
Time Frame: from day 1 to day 15 (all the study duration)
Safety outcome
from day 1 to day 15 (all the study duration)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Wooshin Labottach Co., Ltd.

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Nextrasearch S.r.l.s.

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • 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

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
September 1, 2026

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
October 1, 2026

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 1, 2026

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
June 3, 2026

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 8, 2026

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
June 11, 2026

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
June 11, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 8, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
June 1, 2026

More Information

Terms related to this study

Keywords

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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