Enlargement of the local anesthetized area
Conditions
Interventions
Group 1: One proband's volar forearm gets 6 applications intra-cutaneously of 0,5 mL placebo (0.9% NaCl Lösung) together with 0,5 mL local anaesthetic (Lidocain 0.5%).
Group 2: One proband's volar for
Sponsors
RIEMSER Arzneimittel AG
Eligibility
Sex/Gender
All
Age
18 Years to 40 Years
Inclusion criteria
Inclusion criteria: 1.male and female healthy volunteers, aged 18-40 years 2.Caucasian origin 3.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 4.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: 1. atopic dermatitis or other skin diseases at the designated test areas (forearms) 2. known structure dysfunction of the skin with and without blister formation 3. incompatibility against local anaesthesia or any ingredient of the study medication 4. vegetarians and vegans 5. patch incompatibility 6. known deficiencies (i.e. iron, vitamin B12) 7. excessive hair growth on the forearms 8. concomitant procedures which would interfere with trial medication (as massaging injection area) 9. volunteers with collapse, shock, severe electrolyte disturbance or major dehydration 10. volunteers with increased risk of pulmonary congestion or oedema, severe congestive heart failure 11. known hypersensitivity to hyaluronidase or bovine proteins 12. congenital cardiac defect, venous congestion or shock symptoms 13. infections 14. volunteers with any type of cancer 15. General: 16. known contraindication for study medication 17. unreliability and/ or lack of cooperation, evidence of non-compliance 18. current or previous participation in another clinical trial within prior 12 weeks 19. pregnancy or lactation in female volunteers 20. signs of clinically relevant illness or mental illness up to four weeks prior to entry into the study 21. history of or current alcohol or drug abuse 22. other objections which avoid the participation in the study in the opinion of the investigator 23. 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 |
|---|---|
| size of area of anaesthesia | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. time to reach peak area of anaesthesia (onset) 2. duration of anaesthesia | — |
Countries
Germany
Contacts
Public ContactJohannes Wohlrab
An-Institut für Angewandte Dermatopharmazie Universitätsklinik und Poliklinik für Dermatologie und Venerologie
Outcome results
None listed