Study of the Subdermal Implant "Algeness"

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.

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Key information

Conditions

Skin Aging Facial Wrinkles Lipid Metabolism Disorders Lipoatrophy Lipodystrophy Metabolic Diseases Nutritional and Metabolic Diseases Skin Diseases Skin Diseases, Metabolic Skin and Connective Tissue Diseases Soft Tissue Volume Loss

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Estelab Clinic (Clinical Base of FSBEI FPE Russian Medical Academy of Continuing Professional Education)

Moscow, 119034, Russia

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Algeness Subdermal Implant (Agarose)

Device

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.

Primary outcomes

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).

Sponsors and collaborators

Lead sponsor

Estelab Clinic

Network

Registry information

Official study 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.

Important dates

Study start: 2024
Primary completion: 2025
Study completion: 2025
First posted: Jun 1, 2026
Registry last updated: Jun 1, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed