CompletedNot Applicable

Study of the Subdermal Implant "Ultracol"

Russia23 participantsStarted 2024-07-16

Plain-language summary

Study of the effectiveness of the medical device "Intradermal implant, sterile ULTRACOL based on polydioxanone (ULTRA V Co., Ltd., Korea) 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: * The subject has indications for use according to the manufacturer instructions for the device. * The subject is at least 18 years old at the time of signing the informed consent. * The subject expresses willingness and ability to follow the requirements of the study protocol. * The subject has no contraindications described in the device instructions for use. Exclusion Criteria: * The subject has at least one contraindication described in the device instructions for use, based on initial examination, laboratory tests and medical history. * Women of reproductive age: pregnancy, planning pregnancy during the study period, or breastfeeding. * Use of another product for the same indication during the clinical study. * Participation in another clinical study. * Pre-existing health problems that may compromise compliance with the study protocol. * Patients prone to excessive scarring. * Patients undergoing chemotherapy. * Patients previously treated with intradermal fillers in the planned injection zone with persistent effect.

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, Day 30, Day 60, Day 160 after first injection

Trial details

NCT IDNCT07617350

SponsorEstelab Clinic

Sponsor typeNETWORK

Study typeINTERVENTIONAL

Primary completion2025-03-12

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.