Assessment of wound healing efficacy and local tolerability of a wound gel with intraindividual comparison using an abrasive wound model in a single-center, randomized, investigator-blind clinical investigatio

Not Applicable

• Conditions: 13-570; wound, Protective shieldWound, Protective shield

• Registration Number: DRKS00020584
• Lead Sponsor: Engelhard Arzneimittel GmbH & Co. KG

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2020-02-17
• Study Completion: 2020-03-27
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Complete
• Sex: All
• Target Recruitment: 33

Inclusion Criteria

1. Healthy skin on the volar forearms;
2. 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;
3. Urine pregnancy test negative for all females;
4. Written informed consent obtained.

Exclusion Criteria

1. Acne, suntan, eczema, scars, excessive hair, acute skin infection or skin disease, hyper- or hypopigmentation or tattoos in the test fields;
2. Dark-skinned persons (Fitzpatrick skin types IV–VI);
3. 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;
4. 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;
5. Known hypersensitivity or known allergic reactions to components of the MD or the protective standard wound plaster used;
6. Subjects with diabetes mellitus or presence or history of psoriasis, atopic dermatitis, lichen ruber planus, impaired wound healing or keloid development;
7. Contraindications according to the package leaflet/instructions of use (Hansaplast Sensitive);

Study & Design

• Study Type: interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Assessment of wound healing properties in the test fields based on the level of re-epithelialization on Days 2, 5, 8, 10 and 12 after inducing the wounds on Day 1

Secondary Outcome Measures

Name	Time	Method
Assessment of local tolerability in the test fields based on the level of re-epithelialization and formation of crusts on Days 2, 5, 8, 10 and 12.<br><br>Product performance and product traits will be assessed using a questionnaire (in total 12 closed questions with 7-point answer scale) to be filled out by the subjects on Day 12.