Assessment of Wound Healing, Cooling Efficacy and Local Tolerability of a Wound Care Hydrogel

NCT ID: NCT06309446

Last Updated: 2024-03-13

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 33 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-01-14
• Study Completion Date: 2020-07-02

Brief Summary

Test the wound healing properties of the product as well as the cooling effect and tolerability of a wound care gel.

Detailed Description

The primary goal of the study is to assess the wound healing properties in the test fields, based on the level of re-epithelialization, and to assess the cooling properties in the test fields, immediately after the first application of the Medical Device. The secondary objective was to assess the local tolerability of the test fields after inducing the wounds. The cosmetic outcome was assessed by the investigator and by the subject after 31 days using a visual analog scale (VAS) and by the subjects on day 12 by filling a questionnaire on product performance and times to 100% healing, over 75% healing respectively were derived from the re-epithelization score.

Conditions

Wound

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Zoralan Wound

At the beginning of the study, two small, superficial, abrasive wounds (approximately 1.2 cm in diameter) were induced on one volar forearm of each subject with a minimum distance of 5 cm between the wounds, using a sterile surgical hand brush.

One wound is treated with the medical device by a study nurse and covered with standard semi-occlusive wound plaster (Hansaplast Sensitive wound plaster. Topical application of appoximately 0.2g per test field (approx. 1.2cm in diameter each) once daily during a 12-day treatment period (11 treatments).

Group Type: EXPERIMENTAL

Zoralan Wound

Intervention Type: DEVICE

Topical application of approximately 0.2 g per test field (approx. 1.2 cm in diameter each) once daily during a 12-day treatment period (11 treatments).

No treatment

At the beginning of the study, two small, superficial, abrasive wounds (approximately 1.2 cm in diameter) were induced on one volar forearm of each subject with a minimum distance of 5 cm between the wounds, using a sterile surgical hand brush.

One wound is not treated but covered with standard semi-occlusive wound plaster (Hansaplast Sensitive wound plaster. Covering happens once daily during a 12-day treatment period (11 treatments).

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Zoralan Wound

Topical application of approximately 0.2 g per test field (approx. 1.2 cm in diameter each) once daily during a 12-day treatment period (11 treatments).

Intervention Type: DEVICE

Other Intervention Names

Flamozil; Wound care hydrogel; X92001574

Eligibility Criteria

Inclusion Criteria

• Men and women aged 18 years or older;
• Healthy skin on the volar forearms;
• The physical examination of the skin must be without disease findings unless the investigator considers an abnormality to be irrelevant to the outcome of the clinical investigation;
• Female volunteers of childbearing potential must either be surgically sterile (hysterectomy or tubal ligation) or agree to use a reliable method of contraception with a failure rate of less than 1% per year when used consistently and correctly such as implants, injectables, combined oral contraceptives, some intra uterine devices (IUDs), sexual abstinence or vasectomized partner;
• Urine pregnancy test negative for all females;
• Written informed consent obtained.

Exclusion Criteria

• Acne, suntan, eczema, scars, excessive hair, acute skin infection or skin disease, hyper or hypopigmentation or tattoos in the test fields;
• Dark-skinned persons (Fitzpatrick skin types IV-VI);
• Pregnancy or planned pregnancy or nursing;
• Symptoms of a clinically significant illness that may influence the outcome of the investigation in the 4 weeks before baseline and during the clinical investigation;
• Participation in the treatment phase in another clinical investigation or clinical trial within the last 4 weeks prior to the baseline visit of this clinical investigation and during the conduct of this investigation;
• Known hypersensitivity or known allergic reactions to components of the MD or the protective standard wound plaster used;
• Treatment with systemic medications or medications acting locally in the test field areas which might counter or influence the investigation aim within 2 weeks before the baseline visit (e.g. antihistamines or glucocorticosteroids) and during the conduct of this investigation;
• Subjects who have taken any anticoagulant medication, within 3 weeks prior to Day 1, or platelet aggregation inhibitors within 10 days prior to Day 1 or with a history of hemophilia or any other illness influencing the subject's coagulation system.
• Subjects with diabetes mellitus or presence or history of psoriasis, atopic dermatitis, lichen ruber planus, impaired wound healing or keloid development;
• Contraindications according to the package leaflet/instructions of use (Hansaplast Sensitive);
• If in the opinion of the investigator or physician performing the initial examination the subject should not participate in the clinical investigation, e.g. due to probable noncompliance or inability to understand the investigation and adequately given informed consent;
• Subjects not willing to adhere to trial restrictions, amongst others sauna, solarium are not allowed during the clinical investigation;
• Close affiliation with the investigator (e.g. a close relative) or persons working at bioskin GmbH or subject is an employee of the sponsor;
• Subject with a disposition to develop hypertrophic scarring, keloids or wound healing disorders;
• Evidence of drug or alcohol abuse;
• Subject is institutionalized because of legal or regulatory order.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Bioskin GmbH

INDUSTRY

Sponsor Role: collaborator

Oystershell NV

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Heinrich Siemetzki, M.D.

Role: PRINCIPAL_INVESTIGATOR

Bioskin GmbH

Locations

Bioskin GmbH

Hamburg, , Germany

Countries

Germany

Other Identifiers

381001BS

Identifier Type: -

Identifier Source: org_study_id