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Study of the Subdermal Implant "Ultracol"

25. maj 2026 opdateret af: Estelab Clinic

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.

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.

Studieoversigt

Status

Afsluttet

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

The investigational product is composed of a mixture of polydioxanone and sodium carboxymethylcellulose. The polydioxanone content is as follows: Ultracol 200: 150 mg ±10%, Ultracol 100: 75 mg ±10%. The key difference from the closest analogs (AestheFill® V200, Sculptra™, Ellagen PLLA+CMC 1000 mg) is the presence of polydioxanone in the investigational product.

Thus, the analyzed analogues are not fully interchangeable medical products. The combined composition of Ultracol has not been studied properly. Therefore, during the clinical study, it is necessary to check the safety and effectiveness of a medical product with a combined composition - polydioxanone and sodium carboxymethylcellulose.

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

23

Fase

  • Ikke anvendelig

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

  • Rusland
    • Russia
      • Moscow, Russia, Rusland, 119034
        • Estelab CLinic

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

  • Voksen
  • Ældre voksen

Tager imod sunde frivillige

Ja

Beskrivelse

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.

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Behandling
  • Tildeling: N/A
  • Interventionel model: Enkelt gruppeopgave
  • Maskning: Ingen (Åben etiket)

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: Experimental Group
ULTRACOL Intradermal Implant (Polydioxanone-based). All 23 adult subjects (22 female, 3 male; mean age 51.1, range 37-70) received intradermal injections of ULTRACOL using linear-retrograde technique into the lower dermis or hypodermis. ULTRACOL 100 (100 mg/vial, reconstituted in 1 mL water for injection) used in all 23 patients; ULTRACOL 200 (200 mg/vial, reconstituted in 2 mL water for injection) used in 20 patients. Mean 1.87 injections per patient. Maximum dose: 3 mL per procedure. Treatment zones: nasolabial folds, cheeks, zygomatic area, perioral/periauricular regions, facial oval. Follow-up: Day 30, 60, 160.
Enhed: 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.

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Change in Wrinkle Severity Rating Scale (WSRS) Score
Tidsramme: Baseline, Day 30, Day 60, Day 160 after first injection
Validated 5-point scale (1 = no wrinkles, 5 = extreme wrinkles) assessed by the investigator. A reduction of 1 or more points compared to baseline is considered clinically significant. Units: Score on a scale (1-5).
Baseline, Day 30, Day 60, Day 160 after first injection

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Change in Baker Ptosis Classification
Tidsramme: Baseline, Day 30, Day 60, Day 160 after first injection
4-grade classification of facial soft tissue ptosis assessed by the investigator (Grade I = minimal, Grade IV = severe). Unit: Score on a scale (I-IV).
Baseline, Day 30, Day 60, Day 160 after first injection
Global Aesthetic Improvement Scale (GAIS) - Investigator Assessment
Tidsramme: Day 30, Day 60, Day 160 after first injection
5-point Global Aesthetic Improvement Scale (0 = worse, 1 = no change, 2 = improved, 3 = much improved, 4 = very much improved) assessed by the investigator. Unit: Score on a scale (0-4).
Day 30, Day 60, Day 160 after first injection
Global Aesthetic Improvement Scale (GAIS) - Subject Self-Assessment
Tidsramme: Day 30, Day 60, Day 160 after first injection
5-point Global Aesthetic Improvement Scale (0 = worse, 4 = very much improved) assessed by the subject. Unit: Score on a scale (0-4).
Day 30, Day 60, Day 160 after first injection
Change in Perceived Age (Subject Self-Assessment)
Tidsramme: Baseline, Day 30, Day 60, Day 160 after first injection
Subject self-assessment of perceived age before and after treatment. A reduction of at least 1 year is considered clinically meaningful. Unit: Years.
Baseline, Day 30, Day 60, Day 160 after first injection
Change in Skin Parameters by Multi-Parametric Ultrasound
Tidsramme: Baseline and Day 160 after first injection
Multi-parametric facial skin ultrasound assessing: epidermis thickness (mm), papillary dermis thickness (mm), reticular dermis thickness (mm), subcutaneous fat thickness (mm), vascularization index (%), dermis stiffness via compression elastography (kPa). Unit: Combined imaging parameters reported per individual measurement (mm / % / kPa).
Baseline and Day 160 after first injection
Change in Lemperle Scale (Nasolabial Fold Depth)
Tidsramme: Baseline, Day 30, Day 60, Day 160 after first injection
5-point Lemperle scale for assessment of nasolabial fold depth (0 = no wrinkle, 5 = very deep wrinkle), assessed by the investigator. Unit: Score on a scale (0-5).
Baseline, Day 30, Day 60, Day 160 after first injection
Number of Participants with Adverse Events (AEs) and Adverse Device Effects (ADEs)
Tidsramme: From first injection through Day 160 (160-day follow-up)
Frequency and severity of adverse events (AEs) and adverse device effects (ADEs), assessed by the investigator and recorded throughout the study. Unit: Number of Participants.
From first injection through Day 160 (160-day follow-up)
Number of Participants with Serious Adverse Events (SAEs) and Serious Adverse Device Effects (SADEs)
Tidsramme: From first injection through Day 160 (160-day follow-up)
Frequency of serious adverse events (SAEs) and serious adverse device effects (SADEs), assessed by the investigator and recorded throughout the study. Unit: Number of Participants.
From first injection through Day 160 (160-day follow-up)

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Estelab Clinic

Samarbejdspartnere

Pirogov National Medical Surgical Center

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Faktiske)

16. juli 2024

Primær færdiggørelse (Faktiske)

12. marts 2025

Studieafslutning (Faktiske)

10. april 2025

Datoer for studieregistrering

Først indsendt

23. oktober 2024

Først indsendt, der opfyldte QC-kriterier

25. maj 2026

Først opslået (Faktiske)

1. juni 2026

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

1. juni 2026

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

25. maj 2026

Sidst verificeret

1. maj 2026

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • 060-КИ-МИ-2024

Plan for individuelle deltagerdata (IPD)

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INGEN

Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter

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