Prospective Study to Assess Tissue Responses After Injection With Biostimulatory Products
NCT ID: NCT06093815
Last Updated: 2024-12-13
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
20 participants
INTERVENTIONAL
2023-09-08
2024-11-01
Brief Summary
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Safety endpoint: incidence of adverse events.
Detailed Description
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Assessments under this protocol will include ultrasound of in vivo tissue.
Safety endpoint: incidence of adverse events.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
BASIC_SCIENCE
NONE
Study Groups
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Arm 1
Subjects in Arm 1 will receive injections of biostimulatory products (Radiesse, Sculptra, Ellanse, HArmonyCa) at 3 timepoints (six months, three months and two weeks) prior to removal of redundant abdominal tissue.
Injection
A pre specified amount will be injected in tissue at selected timepoints
Arm 2
Subjects in Arm 2 will receive injections of 1 of 2 selected biostimulatory products (Radiesse or Sculptra) at 1 timepoint (6 months) prior to removal of redundant abdominal tissue.
Injection
A pre specified amount will be injected in tissue at selected timepoints
Interventions
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Injection
A pre specified amount will be injected in tissue at selected timepoints
Eligibility Criteria
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Inclusion Criteria
2. Voluntary participation
3. Ability to comprehend and provide informed consent.
4. Participants agree NOT to use any topical agents or products that will induce skin peeling or change the appearance of the skin in the treatment area, during the study period.
5. Participants agree NOT to undergo any aesthetic treatments that influence the appearance of the skin in the treatment area during the study period.
6. Participants agree NOT to undergo any surgical treatments in the treatment area during the study period.
7. Participants agree NOT to take part in another clinical study or undergo other treatments during the study period.
Exclusion Criteria
2. Any previous treatment in the abdominal area.
3. Planning to receive treatment of any kind in the abdominal area.
4. Acute inflammatory process and/or infection at the injection site.
5. Treatment of skin area with dermatosis.
6. Eczema, exanthema or open wounds.
7. Previous application of over the counter or prescription, oral or topical, anti-wrinkle or skin enhancer products on the abdominal skin within the past 3 months unless allowed by the study and is continued throughout the study.
8. Any contraindication to treatment with biostimulatory products based on the product's IFU.
9. Previous pregnancy or intending to become pregnant during study participation.
10. Known hypersensitivity to biostimulatory products or any of their formulation ingredients.
11. Allergic reaction to topical and local anesthetics.
12. Currently using anticoagulant therapy.
13. Haemophilia / bleeding disorder.
14. Chemotherapy, radiotherapy or high doses of corticosteroids.
15. Systemic infection (e.g., hepatitis).
16. Uncontrolled diabetes mellitus.
17. Any medical condition that may put the participant at increased risk with exposure to biostimulatory products.
18. Any medication that might modulate the immune response.
19. Any other illness or condition that, in the opinion of the investigator, would mean that study participation was not in the best interest of the prospective participant.
20. Is a female of childbearing potential and not using medically effective birth control or is pregnant or lactating.
21. Any serious disease or disorder (medical or psychiatric) that could, in the opinion of the investigator, interfere with the safe completion of treatment according to this protocol or with study.
22. Injection of local anesthesia into the flap during abdominoplasty surgery.
22 Years
65 Years
ALL
Yes
Sponsors
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Merz North America, Inc.
INDUSTRY
Responsible Party
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Principal Investigators
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Ann P Marx, MD
Role: STUDY_DIRECTOR
Merz North America, Inc.
Locations
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Ocean Clinic - Av. Ramon y Cajal 7, 29601
Marbella, , Spain
Countries
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Other Identifiers
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M900311010
Identifier Type: -
Identifier Source: org_study_id