13-570
Conditions
Interventions
Group 1: Tyrosur® CareExpert Wundgel, 0.2 ml/ day topical, covered with standard semi-occlusive wound dressing (Hansaplast sensitive wound plaster)
Group 2: Untreated control field covered with standa
Sponsors
Engelhard Arzneimittel GmbH & Co. KG
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
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
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);
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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
| Measure | Time frame |
|---|---|
| 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. 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. | — |
Countries
Germany
Contacts
Public ContactHeinrich Siemetzki
bioskin GmbH
Outcome results
None listed