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NCT07642973
A Study to Evaluate the Safety and Clinical Performance of a Dexpanthenol Medicated Hydrogel Patch in the Treatment of Standardized Superficial Abrasions
Conditions: Skin Wounds, Abrasion
Sex: All
Ages: 18 Years – 64 Years
Healthy volunteers: Yes
Phase: NA
Enrollment: 40
Sponsor: Wooshin Labottach Co., Ltd.
Location: la U.O.C. Anestesia Rianimazione degli Ospedali Riuniti Padova Sud Monselice PD
Summary
Clinical evaluation of a Dexpanthenol-medicated wound plaster on standardized superficial skin abrasions
Eligibility Criteria
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
Source: ClinicalTrials.gov (NCT07642973). StuddyBuddy aggregates publicly available trial information.