Study of the Subdermal Implant "Algeness"

Estelab Clinic

Status: Completed

Conditions: Soft Tissue Volume Loss; Lipoatrophy; Skin Aging; Facial Wrinkles

Treatments: Device: Algeness Subdermal Implant (Agarose)

Study type: Interventional

Funder types: NETWORK

Identifiers

NCT07618468

2023

Details and patient eligibility

About

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.

Enrollment: 40 patients

Sex: All

Ages: 18 to 70 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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40 participants in 1 patient group

Algeness Subdermal Filler

Experimental group

Description:

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.

Treatment:

Device: Algeness Subdermal Implant (Agarose)