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Study of the Subdermal Implant "Algeness"
Sponsor: Estelab Clinic
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.
Official title: 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.
Key Details
Gender
All
Age Range
18 Years - 70 Years
Study Type
INTERVENTIONAL
Enrollment
40
Start Date
2024-06-08
Completion Date
2025-04-10
Last Updated
2026-06-01
Healthy Volunteers
Yes
Interventions
Algeness Subdermal Implant (Agarose)
Slowly absorbable biocompatible hydrogel based on natural agarose (1.0-3.5%) with phosphate buffer. Four formulations: LD (1%), HD (1.5%), VL (2.5% with hyaluronate), DF (3.5% with hyaluronate). Gamma-sterilized 1.4 mL syringe, single use. Manufactured by GHIMAS S.p.A., Italy. Class III medical device. Indicated for correction of facial contour defects, wrinkles, and soft tissue volume loss.
Locations (1)
Estelab Clinic (Clinical Base of FSBEI FPE Russian Medical Academy of Continuing Professional Education)
Moscow, Russia