Liponovo Tissue Product in Healthy Volunteers

Study Overview
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Brief Summary
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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.

Official Title
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SAFETY STUDY EVALUATING THE SAFETY AND TOLERABILITY OF THE LIPONOVO TISSUE PRODUCT IN HEALTHY VOLUNTEERS

Conditions
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Safety Issues

Intervention / Treatment
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* Other: Liponovo tissue product


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Liponovo tissue product<br>4,5mlLiponovo tissue product, single injection | Other: Liponovo tissue product<br>* Investigational products (Liponovo tissue product and Ringer Acetat) are injected into the dorsal forearm, superficial part of the subcutis. The single injection and a 23G/30mm needle are used. The amount of the injected investiogational products is 4,5 ml for both dorsal forearms (together 4,5ml x2 = 9ml / test subject). The product is always injected in the proximal third of the forearm, into a standardized a quarter circle with a radius of 30mm. Both injections are performed with covered syringe to ensure the double-blinding. After the injection, test subjects get a cold on the injection sites to reduce the bruising.<br>|
| Sham Comparator: Plasebo<br>4,5ml Ringer, single injection | Other: Liponovo tissue product<br>* Investigational products (Liponovo tissue product and Ringer Acetat) are injected into the dorsal forearm, superficial part of the subcutis. The single injection and a 23G/30mm needle are used. The amount of the injected investiogational products is 4,5 ml for both dorsal forearms (together 4,5ml x2 = 9ml / test subject). The product is always injected in the proximal third of the forearm, into a standardized a quarter circle with a radius of 30mm. Both injections are performed with covered syringe to ensure the double-blinding. After the injection, test subjects get a cold on the injection sites to reduce the bruising.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| SAFETY | Sensitization and allergic reactions | Follow up 3 months |