Study of the Subdermal Implant "Ultracol"

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.

Study Overview

• Status: Completed
• Conditions: Skin Aging; Lipodystrophy; Facial Wrinkles; Nasolabial Folds; Facial Lipoatrophy; Senile Skin Atrophy
• Intervention / Treatment: Device: Administration of the prepared solution - 1 time Post injection observation - 30, 60, 160 days from the date of the first injection.

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Actual): 23
• Phase: Not Applicable

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

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.

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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Wrinkle Severity Rating Scale (WSRS) Score	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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Baker Ptosis Classification	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	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	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)	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	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)	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)	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)	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)

Collaborators and Investigators

• Sponsor: Estelab Clinic
• Collaborators: Pirogov National Medical Surgical Center

Study record dates

Study Major Dates

• Study Start (Actual): July 16, 2024
• Primary Completion (Actual): March 12, 2025
• Study Completion (Actual): April 10, 2025

Study Registration Dates

• First Submitted: October 23, 2024
• First Submitted That Met QC Criteria: May 25, 2026
• First Posted (Actual): June 1, 2026

Study Record Updates

• Last Update Posted (Actual): June 1, 2026
• Last Update Submitted That Met QC Criteria: May 25, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Keywords: dermal filler; nasolabial folds; polydioxanone; facial rejuvenation; PDO; wrinkle correction; biostimulator; collagen stimulation; intradermal implant
• Additional Relevant MeSH Terms: Metabolic Diseases; Skin Diseases; Lipid Metabolism Disorders; Skin Diseases, Metabolic; Nutritional and Metabolic Diseases; Skin and Connective Tissue Diseases; Lipodystrophy
• Other Study ID Numbers: 060-КИ-МИ-2024

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No