Study of the Subdermal Implant "Algeness"

NCT07618468 | Completed

• 1 other identifier: 2023
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

Agarose; dermal filler; Algeness; facial rejuvenation

Outcome Measures

Primary Outcomes (1)

• 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).

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

Study Arms (1)

Algeness Subdermal Filler

EXPERIMENTAL

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)

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.

Algeness Subdermal Filler

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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
• Participation in another clinical study within the past 3 months

Sponsors & Collaborators

• Estelab Clinic: lead

Study Sites (1)

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

Moscow, 119034, Russia

Location

MeSH Terms

Conditions

Lipodystrophy

Condition Hierarchy (Ancestors)

Skin Diseases, Metabolic; Skin Diseases; Skin and Connective Tissue Diseases; Lipid Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: NETWORK
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: May 25, 2026
• First Posted: June 1, 2026
• Study Start: June 8, 2024
• Primary Completion: April 10, 2025
• Study Completion: April 10, 2025
• Last Updated: June 1, 2026

Record last verified: 2026-05

Locations

RU (1)