Vascular DiseasesPhase 4DOUBLE-SKINNCT04999618
A New Approach in Laser Surgery Using the Regenerative Solution in Children Diagnosed With Vascular Pathology
A Phase 4 study testing Haemoblock in people with Vascular Diseases and Vascular Malformation, run by Center for Vascular Pathology, Moscow at 1 site in Russia.
Trial 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. Read more about this study
- Who is it for?
- Ages 6 months to 18 years
- Conditions the study is for
- Vascular Diseases, Vascular Malformation, Capillary Malformation-Arteriovenous Malformation
- What is being tested?
- Haemoblock
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 200 participants
- Where
- 1 siteRussia
- Study dates
- 1 Jan 2020to 27 Oct 2021
- Phase
- Phase 4
- 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 6 months to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- clinically diagnosed Vascular Pathology
Who cannot join
- age
- severe allergic reaction
Trial locations and contacts
1 site in 1 country.
About this study
Official title: DOUBLE-SKIN: a New Approach in Laser Surgery Using the Regenerative Solution in Children Diagnosed With Vascular Pathology: a Randomised, Double-blind, Placebo-controlled Trial
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.
- Conditions
- Vascular Diseases, Vascular Malformation, Capillary Malformation-Arteriovenous Malformation, Port-Wine Stain, Sturge-Weber Syndrome, Vascular Tumor
- Being tested
- Haemoblock, Placebo
- Keywords
- Vascular Diseases, Laser treatment, Capillary Malformation, Port-Wine Stain, Vascular Tumor
- Medical subject headings
- Vascular Diseases, Vascular Malformations, Capillary Malformation-Arteriovenous Malformation, Port-Wine Stain, Sturge-Weber Syndrome, Vascular Neoplasms, Capillary Malformations, Congenital, 1
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HaemoblockDrug
Delivering with transdermal patches
PlaceboOther
Delivering with transdermal patches
| Study group | Role | What they receive |
|---|---|---|
| Group with Haemoblock (A) | Active comparator | Not described Receives: Drug: Haemoblock |
| Group without Haemoblock (B) | Placebo comparator | Not described Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Preventing negative outcomes of postoperative infection
Validated scales
Measured: Early postoperative period and at 3 weeks
Secondary outcomes (1)
Preventing prolonged functional recovery
Validated scales
Measured: Early postoperative period and at 3 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Aug 2021
- Study start1 Jan 2020
- Primary completion27 Aug 2021
- Study completion27 Oct 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Vascular DiseasesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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 4
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 200 participants (actual)
Sponsor and investigators
- Lead sponsor
- Center for Vascular Pathology, Moscow
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- 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
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04999618
- Sponsor's protocol ID
- CVPMoscow
- Acronym
- DOUBLE-SKIN
- Status last verified
- Oct 2021
- First submitted
- 17 Jul 2021
- Last updated
- 4 Nov 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Nov 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- DOUBLE-SKIN: a New Approach in Laser Surgery Using the Regenerative Solution in Children Diagnosed With Vascular Pathology: a Randomised, Double-blind, Placebo-controlled Trial
- ClinicalTrials.gov ID
- NCT04999618
- Acronym / sponsor ID
- DOUBLE-SKIN / CVPMoscow
- Conditions
- 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
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 200 participants (actual)
- Lead sponsor
- Center for Vascular Pathology, MoscowUniversity, hospital or other
- Study start
- 1 Jan 2020 (actual)
- Primary completion
- 27 Aug 2021 (actual)
- Study completion
- 27 Oct 2021 (actual)
- First posted
- 11 Aug 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group with Haemoblock (A) | Active comparator | Drug: Haemoblock |
| Group without Haemoblock (B) | Placebo comparator | Other: Placebo |
Who may qualify
- Ages
- 6 months to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (1 listed)
- clinically diagnosed Vascular Pathology
Key exclusion criteria (2 listed)
- age
- severe allergic reaction
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| HaemoblockDelivering with transdermal patches | Drug | Group with Haemoblock (A) |
| PlaceboDelivering with transdermal patches | Other | Group without Haemoblock (B) |
Primary outcome
Preventing negative outcomes of postoperative infection
Time frame: Early postoperative period and at 3 weeks
Validated scales
1 secondary outcome
Preventing prolonged functional recovery
Time frame: Early postoperative period and at 3 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Nov 2021.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
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
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Haemoblock in people with Vascular Diseases and Vascular Malformation, run by Center for Vascular Pathology, Moscow 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 1 inclusion and 2 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 4 Nov 2021. 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Preventing negative outcomes of postoperative infection (time frame: Early postoperative period and at 3 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 4 Nov 2021.