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Study of the Subdermal Implant "Ultracol"
Sponsor: Estelab Clinic
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.
Official title: A Single-center Clinical Study of the Efficacy and Safety of the Medical Device "Intradermal Implant, Sterile ULTRACOL Based on Polydioxanone (ULTRA V Co., Ltd., Korea) in the Correction of Skin Contour Defects.
Key Details
Gender
All
Age Range
18 Years - 70 Years
Study Type
INTERVENTIONAL
Enrollment
23
Start Date
2024-07-16
Completion Date
2025-04-10
Last Updated
2026-06-01
Healthy Volunteers
Yes
Conditions
Interventions
Administration of the prepared solution - 1 time Post injection observation - 30, 60, 160 days from the date of the first injection.
Lyophilized intradermal implant based on polydioxanone (PDO) and sodium carboxymethylcellulose (Na-CMC). ULTRACOL 100: 100 mg/vial (75 mg PDO), reconstituted in 1 mL water for injection. ULTRACOL 200: 200 mg/vial (150 mg PDO), reconstituted in 2 mL water for injection. Administered intradermally using linear-retrograde technique. Maximum dose: 3 mL per procedure. Mean 1.87 injections per subject. Manufactured by ULTRA V Co., Ltd., Republic of Korea. Class III medical device. Biostimulating mechanism: PDO hydrolysis stimulates neocollagenesis.
Locations (1)
Estelab CLinic
Moscow, Russia, Russia