Trial document




drksid header

  DRKS00000356

Trial Description

start of 1:1-Block title

Title

Safety evaluation of Hylase® Dessau 150 IU (bovine testicular hyaluronidase) vs. placebo as adjuvant to local anaesthesia in wound healing by means of a suction blister model in healthy volunteers

end of 1:1-Block title
start of 1:1-Block acronym

Trial Acronym

[---]*

end of 1:1-Block acronym
start of 1:1-Block url

URL of the Trial

[---]*

end of 1:1-Block url
start of 1:1-Block public summary

Brief Summary in Lay Language

Addition of Hyaluronidase to local anaesthetics causes an enlargement of the anesthetic area. Therefor the effect occurs at an earlier time. This study examine, if application of hyaluronidase has an effect on wound healing.

end of 1:1-Block public summary
start of 1:1-Block scientific synopsis

Brief Summary in Scientific Language

Hyaluronidase temporarily lyses the normal interstitial barrier, which consists mainly of hyaluronic acid, a polysaccharide found in the intercellular ground substance of connective tissue.
As a consequence, hyaluronidase decreases the viscosity of the connective tissue, thus increasing diffusion of fluids administered subcutaneously, as local anaesthetics.
In aesthetical and general surgery hyaluronidase is primary used in conjunction with local anaesthetics, to decrease tissue distortion caused by the local anaesthetic, and to increase the area of the anaesthetic infiltrate.
This study examine the influence of hyaluronidase on wound healing.

end of 1:1-Block scientific synopsis
start of 1:1-Block organizational data

Organizational Data

  •   DRKS00000356
  •   2010/03/03
  •   [---]*
  •   no
  •   Approved
  •   keine
end of 1:1-Block organizational data
start of 1:n-Block secondary IDs

Secondary IDs

  •   U1111-1113-8170 
  •   2009-013867-20 
  •   4035476 
  •   CTU 061D  (Riemser Arzneimittel AG)
end of 1:n-Block secondary IDs
start of 1:N-Block indications

Health Condition or Problem studied

  •   Enlargement of the local anesthetized area
end of 1:N-Block indications
start of 1:N-Block interventions

Interventions/Observational Groups

  •   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%).
  •   To a blister will be administered intra-cutaneously 0,5 mL placebo (0.9% NaCl Lösung) together with 0,5 mL local anaesthetic (Lidocain 0.5%).
end of 1:N-Block interventions
start of 1:1-Block design

Characteristics

  •   Interventional
  •   [---]*
  •   Randomized controlled trial
  •   Double or multiple blind
  •   [---]*
  •   Placebo
  •   Other
  •   Parallel
  •   I
  •   [---]*
end of 1:1-Block design
start of 1:1-Block primary endpoint

Primary Outcome

time to suction blister healing
(defined as TEWL decreased to maximally normal TEWL+25% as measured at the corresponding area of the opposite arm)

end of 1:1-Block primary endpoint
start of 1:1-Block secondary endpoint

Secondary Outcome

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)

end of 1:1-Block secondary endpoint
start of 1:n-Block recruitment countries

Countries of Recruitment

  •   Germany
end of 1:n-Block recruitment countries
start of 1:n-Block recruitment locations

Locations of Recruitment

  • [---]*
end of 1:n-Block recruitment locations
start of 1:1-Block recruitment

Recruitment

  •   Actual
  •   2010/03/08
  •   20
  •   Monocenter trial
  •   National
end of 1:1-Block recruitment
start of 1:1-Block inclusion criteria

Inclusion Criteria

  •   Both, male and female
  •   18   Years
  •   40   Years
end of 1:1-Block inclusion criteria
start of 1:1-Block inclusion criteria add

Additional 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

end of 1:1-Block inclusion criteria add
start of 1:1-Block 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

end of 1:1-Block exclusion criteria
start of 1:n-Block addresses

Addresses

  • start of 1:1-Block address primary-sponsor
    • RIEMSER Arzneimittel AG
    • Mr.  Dr. med.  Berno  Müller 
    • An der Wiek 7
    • 17493  Greifswald - Insel Riems
    • Germany
    end of 1:1-Block address primary-sponsor
    start of 1:1-Block address contact primary-sponsor
    end of 1:1-Block address contact primary-sponsor
  • start of 1:1-Block address scientific-contact
    • An-Institut für Angewandte Dermatopharmazie Universitätsklinik und Poliklinik für Dermatologie und Venerologie
    • Mr.  Prof. Dr. med.  Johannes  Wohlrab 
    • Ernst-Grube-Str. 40
    • 06097  Halle
    • Germany
    end of 1:1-Block address scientific-contact
    start of 1:1-Block address contact scientific-contact
    end of 1:1-Block address contact scientific-contact
  • start of 1:1-Block address public-contact
    • An-Institut für Angewandte Dermatopharmazie (IADP) Universitätsklinik und Poliklinik für Dermatologie und Venerologie Martin-Luther-Universität Halle-Wittenberg
    • Mr.  Prof. Dr. med.  Johannes  Wohlrab 
    • Ernst-Grube-Str. 40
    • 06097  Halle
    • Germany
    end of 1:1-Block address public-contact
    start of 1:1-Block address contact public-contact
    end of 1:1-Block address contact public-contact
end of 1:n-Block addresses
start of 1:n-Block material support

Sources of Monetary or Material Support

  • start of 1:1-Block address materialSupport
    • RIEMSER Arzneimittel AG
    • An der Wiek 7
    • 17493  Greifswald - Insel Riems
    • Germany
    end of 1:1-Block address materialSupport
    start of 1:1-Block address contact materialSupport
    end of 1:1-Block address contact materialSupport
end of 1:n-Block material support
start of 1:1-Block state

Status

  •   Recruiting complete, follow-up complete
  •   2010/07/01
end of 1:1-Block state
start of 1:n-Block publications

Trial Publications, Results and other Documents

  • [---]*
end of 1:n-Block publications
* This entry means the parameter is not applicable or has not been set.