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

NCT07642973 | Not Yet Recruiting

• 1 other identifier: MD03/26/WOOSH/DEX
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Skin Wounds; Abrasion

Keywords

superficial wounds; dexpanthenol; plaster

Outcome Measures

Primary Outcomes (1)

• Re-epithelialization Rate

  Measured as the percentage of wound closure compared to baseline (T0) with standardized photography

  day 5 day 7 day 15

Secondary Outcomes (4)

• Kinetics of Wound Closure

  Day 5 day 7

• Subject-Reported Pain

  day 5 day 7

• Scar Quality Assessment

  day 5 day 7 day 15

• general usability

  Day 1, day 5, day 7

Other Outcomes (1)

• Number of AE

  from day 1 to day 15 (all the study duration)

Study Arms (3)

Dexpanthenol

EXPERIMENTAL

On the wound will be applied an experimental Hydrogel plaster with Dexpanthenol

Device: hydrogel plaster with dexpanthenol

Standard plaster

ACTIVE COMPARATOR

On the wound will be applied a standard plaster, with no active ingredients

Device: Standard plaster

No treatment

NO INTERVENTION

The wound is not covered or medicated

Interventions

Standard plaster DEVICE

On the wound will be daily applicated a standard plaster on the market

Standard plaster

hydrogel plaster with dexpanthenol DEVICE

On the wound will be applied daily an hydrogel plaster with Dexpanthenol

Dexpanthenol

Eligibility Criteria

• Age: 18 Years - 64 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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;

You may not qualify if:

• 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)
• Not willing and able to comply with all study protocol requirements

Sponsors & Collaborators

• Wooshin Labottach Co., Ltd.: lead
• Nextrasearch S.r.l.s.: collaborator

Study Sites (1)

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

Monselice, PD, 35043, Italy

Location

Study Officials

• Alessandro Guzzo, MD

  la U.O.C. Anestesia Rianimazione degli Ospedali Riuniti Padova Sud con indirizzo via Albere, 30 Monselice

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Alessandro Guzzo, MD

CONTACT

+39 0429715610; alessandro.guzzo@aulss6.veneto.it

Adolfo Gasparetto, MD

CONTACT

+39 3356641965; adolfogasparetto@nextrasearch.it

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Randomized, Single-Blind (assessor blind), Intra-Individual Controlled study

Study Record Dates

• First Submitted: June 3, 2026
• First Posted: June 11, 2026
• Study Start (Estimated): September 1, 2026
• Primary Completion (Estimated): October 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: June 16, 2026

Record last verified: 2026-06

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ANALYTIC CODE

Locations

IT (1)