Skin WoundsDexpanthenolNCT07642973
A Study to Evaluate the Safety and Clinical Performance of a Dexpanthenol Medicated Hydrogel Patch in the Treatment of Standardized Superficial Abrasions
A study testing hydrogel plaster with dexpanthenol and Standard plaster in people with Skin Wounds and Abrasion, run by Wooshin Labottach Co., Ltd. at 1 site in Italy.
Trial summary
Clinical evaluation of a Dexpanthenol-medicated wound plaster on standardized superficial skin abrasions Read more about this study
- Who is it for?
- Ages 18 to 64 yearsHealthy volunteers can take part
- Conditions the study is for
- Skin Wounds, Abrasion
- What is being tested?
- hydrogel plaster with dexpanthenol and Standard plaster
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteItaly
- Study dates
- Sep 2026to Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 64 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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;
Who cannot join
- 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.
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- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Italy1 site
la U.O.C. Anestesia Rianimazione degli Ospedali Riuniti Padova Sud
Monselice, PD, 35043
Alessandro Guzzo, MD, +39 0429714111, alessandro.guzzo@aulss6.veneto.it
Alessandro Guzzo, MD
About this study
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
Clinical evaluation of a Dexpanthenol-medicated wound plaster on standardized superficial skin abrasions
Read the 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.
- Conditions
- Skin Wounds, Abrasion
- Being tested
- hydrogel plaster with dexpanthenol, Standard plaster
- Keywords
- superficial wounds, dexpanthenol, plaster
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
hydrogel plaster with dexpanthenolDevice
On the wound will be applied daily an hydrogel plaster with Dexpanthenol
Standard plasterDevice
On the wound will be daily applicated a standard plaster on the market
| Study group | Role | What they receive |
|---|---|---|
| Dexpanthenol | Experimental | On the wound will be applied an experimental Hydrogel plaster with Dexpanthenol Receives: Device: hydrogel plaster with dexpanthenol |
| Standard plaster | Active comparator | On the wound will be applied a standard plaster, with no active ingredients Receives: Device: Standard plaster |
| No treatment | No intervention | The wound is not covered or medicated |
What is being measured
The primary outcome is the main question the study is designed to answer.
Re-epithelialization Rate
Measured as the percentage of wound closure compared to baseline (T0) with standardized photography
Measured: day 5 day 7 day 15
Secondary outcomes (4)
Kinetics of Wound Closure
Time to 50% re-epithelialization
Measured: Day 5 day 7
Subject-Reported Pain
Pain during wear and upon plaster removal assessed via a 100-mm Visual Analogue Scale (VAS)
Measured: day 5 day 7
Scar Quality Assessment
using the Vancouver Scar Scale (VSS) (scoring vascularity, pigmentation, pliability, and height)
Measured: 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)
Measured: Day 1, day 5, day 7
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jun 2026
- Study startSep 2026 (estimated)
- Primary completionOct 2026 (estimated)
- Study completionDec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Skin WoundsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Single group
- Model description
- Randomized, Single-Blind (assessor blind), Intra-Individual Controlled study
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Wooshin Labottach Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Nextrasearch S.r.l.s.
- Responsible party
- Sponsor
- Investigators
- Alessandro Guzzo, MD, Principal investigator, la U.O.C. Anestesia Rianimazione degli Ospedali Riuniti Padova Sud con indirizzo via Albere, 30 Monselice
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07642973
- Sponsor's protocol ID
- MD03/26/WOOSH/DEX
- Acronym
- Dexpanthenol
- Status last verified
- Jun 2026
- First submitted
- 3 Jun 2026
- Last updated
- 16 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: When study will be closed and published
Study at a glance
From the registry record, last updated by the sponsor on 16 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT07642973
- Acronym / sponsor ID
- Dexpanthenol / MD03/26/WOOSH/DEX
- Conditions
- Skin Wounds, Abrasion
- Keywords
- superficial wounds, dexpanthenol, plaster
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Wooshin Labottach Co., Ltd.Industry (pharma, biotech, devices)
- Collaborators
- Nextrasearch S.r.l.s.
- Study start
- Sep 2026 (estimated)
- Primary completion
- Oct 2026 (estimated)
- Study completion
- Dec 2026 (estimated)
- First posted
- 11 Jun 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
- Model description
- Randomized, Single-Blind (assessor blind), Intra-Individual Controlled study
| Arm | Type | Receives |
|---|---|---|
| Dexpanthenol | Experimental | Device: hydrogel plaster with dexpanthenolOn the wound will be applied an experimental Hydrogel plaster with Dexpanthenol |
| Standard plaster | Active comparator | Device: Standard plasterOn the wound will be applied a standard plaster, with no active ingredients |
| No treatment | No intervention | –The wound is not covered or medicated |
Who may qualify
- Ages
- 18 to 64 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- 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;
Key exclusion criteria (9 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| hydrogel plaster with dexpanthenolOn the wound will be applied daily an hydrogel plaster with Dexpanthenol | Device | Dexpanthenol |
| Standard plasterOn the wound will be daily applicated a standard plaster on the market | Device | Standard plaster |
Primary outcome
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
4 secondary outcomes
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Jun 2026.
- Individual participant dataSharing planned: Yes. When study will be closed and published
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Alessandro Guzzo, MD principal investigator
la U.O.C. Anestesia Rianimazione degli Ospedali Riuniti Padova Sud con indirizzo via Albere, 30 Monselice
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing hydrogel plaster with dexpanthenol and Standard plaster in people with Skin Wounds and Abrasion, run by Wooshin Labottach Co., Ltd. at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 16 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Alessandro Guzzo, MD (+39 0429715610, alessandro.guzzo@aulss6.veneto.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Re-epithelialization Rate (time frame: day 5 day 7 day 15). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Jun 2026.