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Study of the Subdermal Implant "Ultracol"

NCT07617350 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 23

Last updated 2026-06-01

No results posted yet for this study

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.

Conditions

  • Skin Aging
  • Facial Wrinkles
  • Senile Skin Atrophy
  • Lipodystrophy
  • Facial Lipoatrophy
  • Nasolabial Folds

Interventions

DEVICE

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.

Sponsors & Collaborators

  • Pirogov National Medical Surgical Center

    collaborator OTHER_GOV

  • Estelab Clinic

    lead NETWORK

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2024-07-16
Primary Completion
2025-03-12
Completion
2025-04-10

Countries

  • Russia

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07617350 on ClinicalTrials.gov