Liponovo Tissue Product in Healthy Volunteers

Not Applicable

Completed

• Conditions: Safety Issues

• Registration Number: NCT05518084
• Lead Sponsor: Linio Biotech Oy

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

Study Timeline

• Study Start: 2022-08-24
• Study First Submitted: 2022-08-24
• Study First Submitted QC: 2022-08-24
• Study First Posted: 2022-08-26
• Primary Completion: 2022-12-01
• Study Completion: 2023-02-01
• Status Verified: 2025-06
• Last Update Submitted: 2025-09-22
• Last Update Posted: 2025-09-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 38

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

Primary Outcome Measures

Name	Time	Method
Acute local reactions 20 minutes after injection	Day 0	Examination and structured interview 20 minutes after injection by the investigator
Acute and mid-term adverse events, incl severe adverse events	Day 7 and Day 9	Structured telephone interview by study nurse
Delayed allergic reactions	Day 2, and Day 7	Telephone interviews by the study nurse

Trial Locations

Locations (1)

Terveystalo, Ruoholahti; 🇫🇮 Helsinki, Finland