Liponovo Tissue Product in Healthy Volunteers
Early Phase 1
Recruiting
- Conditions
- Safety Issues
- Interventions
- Other: Liponovo tissue product
- Registration Number
- NCT05518084
- Lead Sponsor
- Vesa Juutilainen
- Brief Summary
The study is a randomized, double blinded, bilaterally controlled trial.The aim is to evaluate the short- and mid term safety of Liponovo tissue product. The safety of the Liponovo tissue product is to be studied in 40 healthy volunteers. Liponovo tissue product is injected into superficial part of the subcutis with one injection to standardized area. The amount of the injection is 4,5 ml. As the control method same sized area is injected with plain Ringer-Acetat solution. The adverse events and serious adverse events are monitored in doctor visits, phone calls and e-diary.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 40
Inclusion Criteria
- Adult (age 18 years or more)
- Healthy skin in the studied area (dorsal forearm, proximal third)
- Able and willing to give informed consent
- Reasonably accessible to the study clinic and compliant to follow-up visits
Exclusion Criteria
- known allergy to any of the preparations used in the study (Liponovo tissue product and Ringer-Acetat) or earlier/known anaphylaxis reaction for any allergen
- hematologic or other bleeding disorder
- use of antitrombotic/ anticoagulation medicine
- autoimmune disease
- immunosupressive disease or medication
- cancer or neoplastic disease
- connective tissue disease
- diabetes type 1 or 2 or other metabolic diseases
- smoking
- pregnancy or nursing
- sunbathing during last 7 days
- a skin disease that is or has been symptomatic in the studied area
- test subjects with previous fat or hyaluronic acid filling under the same area
- those who withhold consent
- Use of following medications:
- Histamine receptor-blockers <7 days before study initiation
- Topical corticosteroids in test area <7 days before study initiation
- Topical calsineurin inhibitors <7days before study initiation
- Longterm (>10days before study initiation) systemic prednisolon >10mg/d
- Omalitsumabi < 4weeks before study initiation
- Doksepin < 7 days before study initiation
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Plasebo Liponovo tissue product 4,5ml Ringer, single injection Liponovo tissue product Liponovo tissue product 4,5mlLiponovo tissue product, single injection
- Primary Outcome Measures
Name Time Method SAFETY Follow up 3 months Sensitization and allergic reactions
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Terveystalo, Ruoholahti
🇫🇮Helsinki, Finland