Clinical evaluation of a Dexpanthenol-medicated wound plaster on standardized superficial skin abrasions
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).
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.
Single group
hydrogel plaster with dexpanthenol
DeviceOn the wound will be applied daily an hydrogel plaster with Dexpanthenol
Standard plaster
DeviceOn the wound will be daily applicated a standard plaster on the market
Re-epithelialization Rate
Measured as the percentage of wound closure compared to baseline (T0) with standardized photography
Kinetics of Wound Closure
Time to 50% re-epithelialization
Subject-Reported Pain
Pain during wear and upon plaster removal assessed via a 100-mm Visual Analogue Scale (VAS)
Scar Quality Assessment
using the Vancouver Scar Scale (VSS) (scoring vascularity, pigmentation, pliability, and height)
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)
Number of AE
Safety outcome
Click on the lead sponsor to view all of their trials.
Wooshin Labottach Co., Ltd.
Lead sponsor
Nextrasearch S.r.l.s.
Collaborator
This trial is not recruiting at the moment. You can still explore other options:
