Study of the Subdermal Implant "Algeness"

Estelab Clinic40 enrolled

Overview

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 Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Skin Aging Facial Wrinkles Soft Tissue Volume Loss Lipoatrophy

Interventions

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.

Eligibility

Sex: ALLMin age: 18 YearsMax age: 70 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (1)

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

Moscow, Russia

Outcomes

Primary Outcomes

Change in Wrinkle Severity Rating Scale (WSRS) Score

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).

Time frame: Baseline (Visit 1, Day 0), Visit 2, Visit 3, Visit 4 post-injection (within 90 days)

Data from ClinicalTrials.gov

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