ClinicalTrials.gg
CompletedNCT04999618DOUBLE-SKINUpdated Nov 4, 2021

A New Approach in Laser Surgery Using the Regenerative Solution in Children Diagnosed With Vascular Pathology

A Phase 4 interventional study of Haemoblock and Placebo in Vascular Diseases, Vascular Malformation and Capillary Malformation-Arteriovenous Malformation, sponsored by Center for Vascular Pathology, Moscow. Completed at 1 site in Russian Federation. Open to participants aged 6 Months to 18 Years. Per ClinicalTrials.gov, last updated 2021-11-04.

Sponsored by Center for Vascular Pathology, Moscow · Phase 4, Interventional, and Prevention

From the registry’s dates

  • Registered 1 year 6 months after the study started (first participant enrolled Jan 2020, registered Jul 2021).
Phase
Phase 4
Study type
Interventional
Enrollment
200
Allocation
Randomized
Ages
6 Months to 18 Years
Sex
All
01

Where this study stands

Counted across the records on this site · 2026-11-12

Among 12 studies in Vascular Diseases with a site in Russian Federation — none open to participants now, none under way, none of them phase 3. Vascular Diseases · Russian Federation.

Enrollment
7th of 11
200 · median 535
Started
2020
with 1 other
Phase 4
2 of 12
none open now
Registered
12th of 12
by date
Lead sponsor
1 of 12
Center for Vascular Pathology, Moscow

Among the 12 studies in Vascular Diseases with a site in Russian Federation, this one is the 7th largest by enrollment of the 11 interventional ones, is one of 2 that started in 2020, is one of 2 in phase 4, and was the 12th registered.

By phase

12 studies; the count open now beside each. This study's row is marked.

Phase 35 · 0 open
Phase 4this study2 · 0 open
No phase1 · 0 open
Observational1 · 0 open
Phase 11 · 0 open
Phase 21 · 0 open
Phase 2/31 · 0 open

By the year they started

First in 2005; this study’s year is marked. 2 started in 2020.

Size and results

Median enrollment 535 across the 11 interventional studies, 1,987 across the 1 observational. Of the 10 that completed or were terminated, 5 (50%) have results posted.

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Download CSVWith an account: the 12 studies in Vascular Diseases with a site in Russian Federation as a file.
02

Study summary

Laser treatment (LT) is the first-line treatment for Vascular Pathology. However even when LT is based on the selective photothermolysis it causes the first-degree burns. While being typically benign by affecting only the epidermis, or outer layer of skin, the burn site is remaining red, dry, and very painful. As Haemoblock contains nanoparticles of silver and is known for both bactericidal and bacteriostatic effects, it likely decreases the potential for infection postoperatively. Furthermore, after fibrin replaces the superficial structure "Hemoblock-albumin", the polyacrylate matrix is plasmolyzed which initiates the cascade of signals required for the tissue regeneration processes. Objective of the study was to examine the effect of the Regenerative Solution "Hemoblock" in lowering postoperative complications in children diagnosed with Vascular Pathology undergoing a laser surgery if delivered with transdermal patches.

03

Conditions studied

  • Vascular Diseases
  • Vascular Malformation
  • Capillary Malformation-Arteriovenous Malformation
  • Port-Wine Stain
  • Sturge-Weber Syndrome
  • Vascular Tumor

Keywords

  • Vascular Diseases
  • Laser treatment
  • Capillary Malformation
  • Port-Wine Stain
  • Vascular Tumor
04

Who can participate

Ages eligible
6 Months to 18 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • clinically diagnosed Vascular Pathology

Exclusion criteria

Exclusion Criteria:

  • age
  • severe allergic reaction
05

Study design

Phase
Phase 4
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Triple (Participant, Investigator, Outcomes assessor)
Enrollment
200 participants (actual)

Study arms

  • Active comparator
    Group with Haemoblock (A)

    Drug: Haemoblock

  • Placebo comparator
    Group without Haemoblock (B)

    Other: Placebo

Interventions

  • DrugHaemoblock

    Delivering with transdermal patches

  • OtherPlacebo

    Delivering with transdermal patches

06

What researchers measure

Primary outcomes

  1. Preventing negative outcomes of postoperative infection

    Validated scales

    Time frame: Early postoperative period and at 3 weeks

Secondary outcomes

  1. Preventing prolonged functional recovery

    Validated scales

    Time frame: Early postoperative period and at 3 weeks

Other outcomes

  1. Preventing likelihood of mental health issues

    Validated scales

    Time frame: Early postoperative period and at 3 weeks

07

Study locations

1 site
  • The Vascular Anomalies Center (VAC) "Hemangioma"
    Moscow, 109028, Russian Federation
08

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Ran from Jan 2020 to primary completion in Aug 2021, 19 months.

Of 16 phase 4 interventional studies under Vascular Diseases, half reached primary completion within 56 months of starting (the median), counting those still running; a quarter within 25 and three quarters within 84. This study's 19 months is below that.

How these figures are worked out, and which studies are left out of them.

Registered
Jul 17, 2021
First posted
Aug 11, 2021
StartActual
Jan 1, 2020
Primary completionActual
Aug 27, 2021
CompletionActual
Oct 27, 2021
Last update
Nov 4, 2021
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Nov 4, 2021, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT04999618
Lead sponsor
Center for Vascular Pathology, Moscow
Responsible party
Sponsor
First posted
Aug 11, 2021
Start date
Jan 1, 2020
Primary completion
Aug 27, 2021
Completion
Oct 27, 2021
Last update
Nov 4, 2021

Study contacts

Ekaterina M Listovskaya, BSc
principal investigator · The Vascular Anomalies Center (VAC) "Hemangioma",
Dmitry V Romanov, MD
study chair · The Vascular Anomalies Center (VAC) "Hemangioma"
Alexander Plotkin, PhD
study chair · Moscow Regional Research Institute of Blood

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Oct 2021. You cannot join it, but the record below documents what was studied.

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