Study of the Subdermal Implant "Ultracol"

Estelab Clinic23 enrolled

Overview

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.

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

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

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

Interventions

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.

Eligibility

Sex: ALLMin age: 18 YearsMax age: 70 YearsHealthy volunteers:

Medical Language ↔ Plain English

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.

Locations (1)

Estelab CLinic

Moscow, Russia, Russia

Outcomes

Primary Outcomes

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).

Time frame: Baseline, Day 30, Day 60, Day 160 after first injection

Secondary Outcomes

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).

Time frame: 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).

Time frame: 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).

Time frame: 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.

Time frame: 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).

Data from ClinicalTrials.gov

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