Enlargement of the local anesthetized area
Conditions
Interventions
Group 1: To a blister will be administered intra-cutaneously 75 IU Hylase® "Dessau" (0.5 mL of 150 IU/mL solution150 IU) together with 0,5 mL local anaesthetic (Lidocain 0.5%).
Group 2: To a blister
Sponsors
RIEMSER Arzneimittel AG
Eligibility
Sex/Gender
All
Age
18 Years to 40 Years
Inclusion criteria
Inclusion criteria: right hander Caucasian origin written informed consent given by volunteer after being provided with detailed information about the nature, risks, and scope of the clinical trial as well as the expected desirable and adverse effects of the drug; female subjects of childbearing potential willing to use contraception during the study period (i.e. abstinence, oral contraception, intrauterine device, diaphragm, condom, spermicide, implant contraception, systemic contraception) or have secondary infertility or whose partner had a vasectomy, or female subjects of non childbearing potential (i.e. had hysterectomy, bilateral ovariectomy, tubal ligation) or are post-menopausal defined as absence of menstrual bleeding for 1 year, or 6 month if laboratory confirmation of hormonal status
Exclusion criteria
Exclusion criteria: atopic dermatitis or other skin diseases at the designated test areas (forearms); known structure dysfunction of the skin with and without blister formation; incompatibility against local anaesthesia or any ingredient of the study medication; vegetarians and vegans; patch incompatibility; known deficiencies (i.e. iron, vitamin B12); excessive hair growth on the forearms; concomitant procedures which would interfere with trial medication (as massaging injection area); volunteers with collapse, shock, severe electrolyte disturbance or major dehydration; volunteers with increased risk of pulmonary congestion or oedema, severe congestive heart failure; known hypersensitivity to hyaluronidase or bovine proteins; congenital cardiac defect, venous congestion or shock symptoms; infections; volunteers with any type of cancer: known contraindication for study medication; unreliability and/ or lack of cooperation, evidence of non-compliance; current or previous participation in another clinical trial within prior 12 weeks; pregnancy or lactation in female volunteers; signs of clinically relevant illness or mental illness up to four weeks prior to entry into the study; history of or current alcohol or drug abuse; other objections which avoid the participation in the study in the opinion of the investigator; legal incapacity and/or other circumstances rendering the volunteer able to understand the nature, scope and possible consequences of the study
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| time to suction blister healing (defined as TEWL decreased to maximally normal TEWL+25% as measured at the corresponding area of the opposite arm) | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. point of complete re-epithelisation (closure of the wound) 2. photo documentation for wound surface evaluation 3. Laser-Doppler-Flow (control measurement at the corresponding area of the opposite arm) | — |
Countries
Germany
Contacts
Public ContactJohannes Wohlrab
An-Institut für Angewandte Dermatopharmazie (IADP) Universitätsklinik und Poliklinik für Dermatologie und Venerologie Martin-Luther-Universität Halle-Wittenberg
Outcome results
None listed