Double-blind, block-randomised, placebo-controlled prospective trial with intraindividual comparison to assess the efficacy and safety of hyaluronidase (Hylase® Dessau) vs. placebo as adjuvant to local anaesthesia
- Conditions
- Enlargement of the local anesthetized area
- Registration Number
- DRKS00000361
- Lead Sponsor
- RIEMSER Arzneimittel AG
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete
- Sex
- All
- Target Recruitment
- 44
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
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
Study & Design
- Study Type
- interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method size of area of anaesthesia
- Secondary Outcome Measures
Name Time Method 1. time to reach peak area of anaesthesia (onset)<br>2. duration of anaesthesia