Study of the Subdermal Implant "Algeness"

May 25, 2026 updated by: Chebotareva Yulia Yurievna, Estelab Clinic

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.

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 Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

40

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Russia
      • Moscow, Russia, 119034
        • Estelab Clinic (Clinical Base of FSBEI FPE Russian Medical Academy of Continuing Professional Education)

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Algeness Subdermal Filler
All 40 female subjects (mean age 40.5, range 22-64) received subdermal injections of Algeness using linear-retrograde technique. One of four formulations was selected based on lesion depth and location: LD (1% agarose, superficial subdermal), HD (1.5%, subdermal), VL (2.5%, deep subdermal), DF (3.5%, deep subdermal). Up to 10 syringes (1.4 mL each) per procedure. Follow-up: Visits 2, 3, and 4 post-implantation.
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Wrinkle Severity Rating Scale (WSRS) Score
Time Frame: Baseline (Visit 1, Day 0), Visit 2, Visit 3, Visit 4 post-injection (within 90 days)
Validated 5-point Wrinkle Severity Rating Scale (1 = absent, 5 = extreme) assessed by the investigator. A reduction of 1 or more points compared to baseline is considered clinically significant. Unit: Score on a scale (1-5).
Baseline (Visit 1, Day 0), Visit 2, Visit 3, Visit 4 post-injection (within 90 days)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Estelab Clinic

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 8, 2024

Primary Completion (Actual)

April 10, 2025

Study Completion (Actual)

April 10, 2025

Study Registration Dates

First Submitted

May 25, 2026

First Submitted That Met QC Criteria

May 25, 2026

First Posted (Actual)

June 1, 2026

Study Record Updates

Last Update Posted (Actual)

June 1, 2026

Last Update Submitted That Met QC Criteria

May 25, 2026

Last Verified

May 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2023 (GRAMMY Museum Foundation)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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