NCT07618468CompletedNot Applicable
A Single-center Clinical Study of the Efficacy and Safety of the Medical Device "Algeness Subdermal Implant Based on Agarose (Ghimas SpA/Ghimas SpA, Italy) in the Correction of Skin Contour Defects.
Estelab Clinic1 site in 1 country40 target enrollmentStarted: June 8, 2024Last updated:
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Enrollment
- 40
- Locations
- 1
Study Overview
Brief Summary
A single-center clinical study of the efficacy and safety of the medical device "Algeness subdermal implant based on agarose (Ghimas SpA/Ghimas SpA, Italy) in the correction of skin contour defects.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 70 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •Age between 30 and 65 years inclusive
- •Presence of signs of age-related facial skin changes (decreased turgor, elasticity, fine wrinkles, contour defects)
- •Signed informed voluntary consent
- •Willingness and ability to comply with study procedures and attend all scheduled visits
Exclusion Criteria
- •Age under 18 years
- •Individual intolerance or allergy to any component of the investigational device
- •Diagnosed tendency to keloid or hypertrophic scarring
- •Severe chronic diseases in the acute phase
- •Acute forms of dermatological diseases
- •Coagulation disorders
- •Treatment with medications affecting blood coagulation
- •Inflammatory or infectious processes in the injection zones
- •Diagnosed autoimmune pathologies
- •Pregnancy and lactation period
- •Filler injections in the same area within the past 12 months
- •Laser procedures or chemical peels within the past 3 months
- •Oncological diseases in history or at the time of inclusion
- •Participation in another clinical study within the past 3 months
Investigators
Chebotareva Yulia Yurievna
Principal Investigator
Estelab Clinic
Study Sites (1)
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