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Study of the Subdermal Implant "Ultracol"

25 de mayo de 2026 actualizado por: 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.

Descripción general del estudio

Estado

Terminado

Condiciones

Intervención / Tratamiento

Descripción detallada

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.

Tipo de estudio

Intervencionista

Inscripción (Actual)

23

Fase

  • No aplica

Contactos y Ubicaciones

Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.

Ubicaciones de estudio

  • Rusia
    • Russia
      • Moscow, Russia, Rusia, 119034
        • Estelab CLinic

Criterios de participación

Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.

Criterio de elegibilidad

Edades elegibles para estudiar

  • Adulto
  • Adulto Mayor

Acepta Voluntarios Saludables

Sí

Descripción

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.

Plan de estudios

Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.

¿Cómo está diseñado el estudio?

Detalles de diseño

  • Propósito principal: Tratamiento
  • Asignación: N / A
  • Modelo Intervencionista: Asignación de un solo grupo
  • Enmascaramiento: Ninguno (etiqueta abierta)

Armas e Intervenciones

Grupo de participantes/brazo
Intervención / Tratamiento
Experimental: 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.
Dispositivo: 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.

¿Qué mide el estudio?

Medidas de resultado primarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Change in Wrinkle Severity Rating Scale (WSRS) Score
Periodo de tiempo: 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

Medidas de resultado secundarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Change in Baker Ptosis Classification
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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)
Periodo de tiempo: 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
Periodo de tiempo: 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)
Periodo de tiempo: 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)
Periodo de tiempo: 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)
Periodo de tiempo: 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)

Colaboradores e Investigadores

Aquí es donde encontrará personas y organizaciones involucradas en este estudio.

Patrocinador

Estelab Clinic

Colaboradores

Pirogov National Medical Surgical Center

Fechas de registro del estudio

Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados ​​por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.

Fechas importantes del estudio

Inicio del estudio (Actual)

16 de julio de 2024

Finalización primaria (Actual)

12 de marzo de 2025

Finalización del estudio (Actual)

10 de abril de 2025

Fechas de registro del estudio

Enviado por primera vez

23 de octubre de 2024

Primero enviado que cumplió con los criterios de control de calidad

25 de mayo de 2026

Publicado por primera vez (Actual)

1 de junio de 2026

Actualizaciones de registros de estudio

Última actualización publicada (Actual)

1 de junio de 2026

Última actualización enviada que cumplió con los criterios de control de calidad

25 de mayo de 2026

Última verificación

1 de mayo de 2026

Más información

Términos relacionados con este estudio

Palabras clave

Términos MeSH relevantes adicionales

Otros números de identificación del estudio

  • 060-КИ-МИ-2024

Plan de datos de participantes individuales (IPD)

¿Planea compartir datos de participantes individuales (IPD)?

NO

Información sobre medicamentos y dispositivos, documentos del estudio

Estudia un producto farmacéutico regulado por la FDA de EE. UU.

No

Estudia un producto de dispositivo regulado por la FDA de EE. UU.

No

Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .

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