Study of the Subdermal Implant "Algeness"

NCT07618468 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 40

Last updated 2026-06-01

No results posted yet for this study

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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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07618468 on ClinicalTrials.gov