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Skin AgingNCT07617350

Study of the Subdermal Implant "Ultracol"

A study testing Administration of the prepared solution - 1 time Post injection observation - 30, 60, 160 days from the date of the first injection. in people with Skin Aging and Facial Wrinkles, run by Estelab Clinic at 1 site in Russia.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

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. Read more about this study

Who is it for?
Ages 18 to 70 yearsHealthy volunteers can take part
Conditions the study is for
Skin Aging, Facial Wrinkles, Senile Skin Atrophy
What is being tested?
Administration of the prepared solution - 1 time Post injection observation - 30, 60, 160 days from the date of the first injection.
Could I receive a placebo?
No, everyone receives an active treatment
How many people
23 participants
Where
1 siteRussia
Study dates
16 Jul 2024to 10 Apr 2025
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 70 years
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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.

Trial locations and contacts

1 site in 1 country.

Russia1 site

  • Estelab CLinic

    Moscow, Russia, 119034

Other trials in Russia

About this study

Official 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.

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.

Read the 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.

Being tested
Administration of the prepared solution - 1 time Post injection observation - 30, 60, 160 days from the date of the first injection.
Keywords
polydioxanone, PDO, dermal filler, biostimulator, nasolabial folds, wrinkle correction, facial rejuvenation, collagen stimulation, intradermal implant
Medical subject headings
Lipodystrophy

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • 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.

Study groups in NCT07617350
Study groupRoleWhat they receive
Experimental GroupExperimentalULTRACOL 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.
Receives: Device: Administration of the prepared solution - 1 time Post injection observation - 30, 60, 160 days from the date of the first injection.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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).

    Measured: Baseline, Day 30, Day 60, Day 160 after first injection

Secondary outcomes (8)

  1. 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).

    Measured: Baseline, Day 30, Day 60, Day 160 after first injection

  2. 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).

    Measured: Day 30, Day 60, Day 160 after first injection

  3. 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).

    Measured: Day 30, Day 60, Day 160 after first injection

  4. 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.

    Measured: Baseline, Day 30, Day 60, Day 160 after first injection

  5. 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).

    Measured: Baseline and Day 160 after first injection

  6. 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).

    Measured: Baseline, Day 30, Day 60, Day 160 after first injection

  7. 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.

    Measured: From first injection through Day 160 (160-day follow-up)

  8. 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.

    Measured: From first injection through Day 160 (160-day follow-up)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted1 Jun 2026
  2. Study start16 Jul 2024
  3. Primary completion12 Mar 2025
  4. Study completion10 Apr 2025

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Model description
A study without a control group, without a comparison device, blinding and randomization are not required. In order to increase the clinical significance and generalizability of the data, the inclusion/exclusion criteria and requirements for the treatment plan are formulated as openly as possible, without compromising the reliability of the data. The observation period more than covers the period for assessing the safety of the device. The studied MD does not enter the systemic circulation, therefore, safety issues may arise upon direct administration or slightly later. The results of toxicological studies and sterility studies are confirmed within the framework of this clinical trial program. Residual clinical risks requiring additional study within the framework of the current program have not been identified. The existing clinical experience of using the medical device in question in other countries confirms the suitability of use in accordance with the instructions for use.
Masking
None (open label)
Enrolment
23 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07617350
Sponsor's protocol ID
060-КИ-МИ-2024
Status last verified
May 2026
First submitted
23 Oct 2024
Last updated
1 Jun 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A study testing Administration of the prepared solution - 1 time Post injection observation - 30, 60, 160 days from the date of the first injection. in people with Skin Aging and Facial Wrinkles, run by Estelab Clinic at 1 site in Russia.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 1 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Russia. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in Wrinkle Severity Rating Scale (WSRS) Score (time frame: Baseline, Day 30, Day 60, Day 160 after first injection). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07617350.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Jun 2026; AzTrials last refreshed its copy on 6 Nov 2026.

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