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Completed

NCT Number: NCT07617350

Study of the Subdermal Implant "Ultracol"

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.

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Key information

Conditions

Skin Aging Facial Lipoatrophy Facial Wrinkles Lipid Metabolism Disorders Lipodystrophy Metabolic Diseases Nasolabial Folds Nutritional and Metabolic Diseases Senile Skin Atrophy Skin Diseases Skin Diseases, Metabolic Skin and Connective Tissue Diseases

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Estelab CLinic

Moscow, Russia, 119034

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Administration of the prepared solution - 1 time Post injection observation - 30, 60, 160 days from the date of the first injection.

Device

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.

Primary outcomes

  1. Change in Wrinkle Severity Rating Scale (WSRS) Score

    Time frame: 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).

Secondary outcomes

  1. Change in Baker Ptosis Classification

    Time frame: 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).

  2. Global Aesthetic Improvement Scale (GAIS) - Investigator Assessment

    Time frame: 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).

  3. Global Aesthetic Improvement Scale (GAIS) - Subject Self-Assessment

    Time frame: 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).

  4. Change in Perceived Age (Subject Self-Assessment)

    Time frame: 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.

  5. Change in Skin Parameters by Multi-Parametric Ultrasound

    Time frame: 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).

  6. Change in Lemperle Scale (Nasolabial Fold Depth)

    Time frame: 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).

  7. Number of Participants with Adverse Events (AEs) and Adverse Device Effects (ADEs)

    Time frame: 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.

  8. Number of Participants with Serious Adverse Events (SAEs) and Serious Adverse Device Effects (SADEs)

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Estelab Clinic

Network

Collaborators

  • Pirogov National Medical Surgical Center

Registry information

Official study 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.

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Jun 1, 2026
Registry last updated
Jun 1, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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