Eligibility |
Inclusion Criteria:
1. Healthy male & females; 22 to 65 years of age.
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:
1. Any previous surgery in the abdominal area.
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.
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