In this study, healthy subjects get an artificial over-injection with Hyaluron acid filler on the back of the hands. To demonstrate the effectiveness of hylase® "Dessau" as an antidote for hyaluronic acid filler, the injected fillers are subsequently treated with a defined amount of hylase® "Dessau" .
Conditions
Interventions
Trade Name: Hylase "Dessau" 150 I.E.
Product Name: Hylase "Dessau" 150 I.E.
Pharmaceutical Form: Powder for solution for injection
INN or Proposed INN: Hyaluronidase
Other descriptive name: HYALURONID
Sponsors
RIEMSER Pharma GmbH
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: • Female and male subjects aged = 18 years and =65 years • Written consent of study participants and ability to understand and follow the study and instructions • Healthy subjects in good physical condition • Heart rate >50 bis 90 to 50 to =65 years) yes F.1.3.1 Number of subjects for this age range 19
Exclusion criteria
Exclusion criteria: 1. Known hypersensitivity to hyaluronidase, bovine proteins and / or gelatin 2. Pregnancy or breastfeeding throughout the study period 3. Women of childbearing potential who do not use contraceptive methods with a Pearl Index = 1, eg. Eg pill, implant, depot injection, sterilization (exception: menopause since =1 year) 4. Subjects with congenital heart disease, venous congestion or shock symptoms 5. Subjects with infections or infected treatment area 6. Known insect poison allergy 7. Subjects with infections, wounds and skin diseases and / or caused by stitches or bites swelling in the treatment area 8. Existing alcohol and / or drug addiction 9. Subjects simultaneously taking medicines containing antihistamines, heparin, morphine, chondroitin sulfate B, cholic acid, dicumarol, vitamin C, flavonoids, sulphonate detergents, salicylic acid derivatives and heavy metal ions (Fe, Mn, Cu, Zn, Hg), salicylic acid derivatives, histamine, calcium or phosphates. These substances can inhibit or enhance the action of the hylase. 10. Subjects with Cancer and Autoimmune Diseases (e.g., psoriasis) 11. Subjects with known immune deficiency 12. Tendency to keloid formation and / or hypertrophic scarring 13. Participation in another study within the last 30 days 14. Subjects who are unwilling or unable to follow the requirements of the protocol 15. Employees / Relatives of the Sponsor or Employees / Relatives of the Head of the Clinical Trial (LKP)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Determination of a tolerated and effective dose of Hylase® "Dessau" (bovine hyaluronidase) as an antidote for the treatment of overcorrections (Blue Lines, Persistent Swelling, vascular involvement) by Hyaluronsäurefiller based on the treatment artificially caused overspray on the hands.;Secondary Objective: - Assessment of the safety and tolerability of Hylase® "Dessau" in clinical use with hyaluronic acid filler • Detection of possible occurrence of known adverse events after treatment with Hylase® "Dessau" (bovine hyaluronidase) (according to Fachinfo Stand 11/2018) • Detection of any new, as yet unknown adverse events after treatment with Hylase® "Dessau";Primary end point(s): Determination of the dose of hylase at 1 and 2 day (s) after treatment with a Hyaluronic acid filler a response after 24 h, complete volume reduction by palpation, and ultrasound. A response is clearly defined by a palpation value of 0 or 1, one with ultrasound demonstrated full volume reduction of more than 90%, determined by the blinded investigator.;Timepoint(s) of evaluation of this end point: Day 1 or 2 after HA filler application. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Assessment of the safety and tolerability of Hylase® "Dessau" in clinical use as an antidote for hyaluronic acid filler - Number of adverse events per dose and HA filler - Number of expected side effects per dose and HA filler - Number of unexpected side effects per dose and HA filler Detection of adverse events and side effects after treatment with HA fillers Assessment of volume reduction with 3D camera;Timepoint(s) of evaluation of this end point: Day 1, 2, 7 or 8, and 14. | — |
Countries
Germany
Contacts
Public ContactMedical Affairs
Riemser Pharma GmbH
Outcome results
None listed