CompletedNot Applicable

Study of the Subdermal Implant "Algeness"

Russia40 participantsStarted 2024-06-08

Plain-language 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.

Who can participate

Age range

18 Years – 70 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Change in Wrinkle Severity Rating Scale (WSRS) Score

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

Trial details

NCT IDNCT07618468

SponsorEstelab Clinic

Sponsor typeNETWORK

Study typeINTERVENTIONAL

Primary completion2025-04-10

View on ClinicalTrials.gov More Skin Aging trials

Who can participate

Age range

18 Years – 70 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.