Study of the Subdermal Implant "Algeness"
NCT07618468 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 40
Last updated 2026-06-01
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.
Conditions
- Skin Aging
- Facial Wrinkles
- Soft Tissue Volume Loss
- Lipoatrophy
Interventions
- DEVICE
-
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.
Sponsors & Collaborators
-
Estelab Clinic
lead NETWORK
Study Design
- Allocation
- NA
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 18 Years
- Max Age
- 70 Years
- Sex
- ALL
- Healthy Volunteers
- Yes
Timeline & Regulatory
- Start
- 2024-06-08
- Primary Completion
- 2025-04-10
- Completion
- 2025-04-10
Countries
- Russia
Study Locations
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