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Liponovo Tissue Product in Healthy Volunteers (SAFETY)

Primary Purpose

Safety Issues

Status
Recruiting
Phase
Early Phase 1
Locations
Finland
Study Type
Interventional
Intervention
Liponovo tissue product
Sponsored by
Vesa Juutilainen
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Safety Issues

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Terveystalo, RuoholahtiRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Sham Comparator

Arm Label

Liponovo tissue product

Plasebo

Arm Description

4,5mlLiponovo tissue product, single injection

4,5ml Ringer, single injection

Outcomes

Primary Outcome Measures

SAFETY
Sensitization and allergic reactions

Secondary Outcome Measures

Full Information

First Posted
August 24, 2022
Last Updated
August 24, 2022
Sponsor
Vesa Juutilainen
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1. Study Identification

Unique Protocol Identification Number
NCT05518084
Brief Title
Liponovo Tissue Product in Healthy Volunteers
Acronym
SAFETY
Official Title
SAFETY STUDY EVALUATING THE SAFETY AND TOLERABILITY OF THE LIPONOVO TISSUE PRODUCT IN HEALTHY VOLUNTEERS
Study Type
Interventional

2. Study Status

Record Verification Date
August 2022
Overall Recruitment Status
Recruiting
Study Start Date
August 24, 2022 (Actual)
Primary Completion Date
September 1, 2023 (Anticipated)
Study Completion Date
September 1, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Vesa Juutilainen

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Safety Issues

7. Study Design

Primary Purpose
Treatment
Study Phase
Early Phase 1
Interventional Study Model
Single Group Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
40 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Liponovo tissue product
Arm Type
Experimental
Arm Description
4,5mlLiponovo tissue product, single injection
Arm Title
Plasebo
Arm Type
Sham Comparator
Arm Description
4,5ml Ringer, single injection
Intervention Type
Other
Intervention Name(s)
Liponovo tissue product
Intervention Description
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.
Primary Outcome Measure Information:
Title
SAFETY
Description
Sensitization and allergic reactions
Time Frame
Follow up 3 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Enni Sanmark, PhD
Phone
+358408446940
Email
enni@linio-biotech.com
First Name & Middle Initial & Last Name or Official Title & Degree
Vesa Juutilainen
Email
vesa.juutilainen@terveystalo.com
Facility Information:
Facility Name
Terveystalo, Ruoholahti
City
Helsinki
Country
Finland
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Vesa Juutilainen

12. IPD Sharing Statement

Plan to Share IPD
No

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Liponovo Tissue Product in Healthy Volunteers

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