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

RIEMSER Arzneimittel AG0 sites44 target enrollmentMarch 3, 2010

Overview

No summary available.

Registry

who.int

Start Date

March 3, 2010

End Date

September 1, 2010

Last Updated

last year

Study Type

Interventional

Sex

All

Sponsor

•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