Facial Wrinkles, Lipoatrophy, Skin Aging, Soft Tissue Volume Loss
Conditions
Keywords
Agarose, dermal filler, Algeness, facial rejuvenation
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.
Interventions
DEVICEAlgeness 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.
Sponsors
Estelab Clinic
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Wrinkle Severity Rating Scale (WSRS) Score | 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). |
Countries
Russia
Outcome results
None listed