Prospective Study to Assess Tissue Responses After Injection With Biostimulatory Products (NCT06093815) | Clinical Trial Compass
CompletedNot Applicable
Prospective Study to Assess Tissue Responses After Injection With Biostimulatory Products
Spain20 participantsStarted 2023-09-08
Plain-language summary
The objective of this study is to identify and assess in vivo tissue responses after injection with various biostimulatory products at various timepoints. The study will also provide tissue specimens which will be used in a subsequent study.
Safety endpoint: incidence of adverse events.
Who can participate
Age range22 Years – 65 Years
SexALL
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Inclusion criteria
✓. Healthy male \& females; 22 to 65 years of age.
✓. Voluntary participation
✓. Ability to comprehend and provide informed consent.
✓. 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.
✓. Participants agree NOT to undergo any aesthetic treatments that influence the appearance of the skin in the treatment area during the study period.
✓. Participants agree NOT to undergo any surgical treatments in the treatment area during the study period.
✓. Participants agree NOT to take part in another clinical study or undergo other treatments during the study period.
Exclusion criteria
✕. Any previous surgery in the abdominal area.
✕. Any previous treatment in the abdominal area.
✕. Planning to receive treatment of any kind in the abdominal area.
✕. Acute inflammatory process and/or infection at the injection site.
✕. Treatment of skin area with dermatosis.
✕. Eczema, exanthema or open wounds.
What they're measuring
1
Ultrasound Analyses
Timeframe: 6 months, 3 months and 2 weeks prior to surgery timepoint(s)
✕. 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.
✕. Any contraindication to treatment with biostimulatory products based on the product's IFU.