Phase II Pilot Study: To determine an effective and tolerable dose of Hylase® Dessau (hyaluronidase from cattle) in the treatment of hyaluronic acid hypodermic overdose by injecting a defined amount of hyaluronic acid into the skin of healthy volunteers

Phase 1

• Conditions: 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 .; Therapeutic area: Not possible to specify

• Registration Number: EUCTR2019-001151-40-DE
• Lead Sponsor: RIEMSER Pharma GmbH

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2019-04-24
• Last Update Posted: 20 April 2020

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 57

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 beats/Minute and blood pressure of systolic >90 to <140 and diastolic >50 to <90 mmHg

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 38
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 19

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)

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified