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Capillary MalformationsPhase 3NCT02764411

Onreltea (Brimonidine) Gel In Pediatric Patients With Capillary Malformations

A Phase 3 study testing Brimonidine 0.33% gel in people with Capillary Malformations, run by The Hospital for Sick Children at 1 site in Canada.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial summary

Capillary Malformations (CM) affect a significant proportion of otherwise healthy children and may lead to psychological discomfort if left untreated. A significant proportion of untreated lesions undergo soft tissue thickening and darker discoloration later in life due to progressive ectasia of the affected vessels. Read more about this study

Who is it for?
Ages 12 to 17 years
Conditions the study is for
Capillary Malformations
What is being tested?
Brimonidine 0.33% gel
Could I receive a placebo?
No, everyone receives an active treatment
How many people
6 participants
Where
1 siteCanada
Study dates
Jun 2016to Oct 2018
Phase
Phase 3
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 12 to 17 years
  • All sexes
  • No healthy volunteers
  • Child

Who may be able to join

  • diagnosis of facial capillary malformation (port-wine stain, PWS) made by a dermatologist
  • age: 12-17 years of age
  • weight > 45 kg
  • lesions with a surface area < 100 cm2
  • signed consent and assent for study participation

Who cannot join

  • skin breakdown overlying the malformation due to other dermatological conditions (e.g. eczema, psoriasis)
  • current or treatment with laser the past 3 months
  • other topical treatments used within the past 4 weeks (e.g. rapamycin, corticosteroids, calcineurin inhibitors, etc)
  • known chronic renal or hepatic disorders
  • known cardiovascular disorders
  • other systemic medications that potentially interact with Brimonidine (opiates, chlorpromazine, methyphenidate, reserpine, etc)
Show all 9Show fewer
  • mixed capillary/ venous or lymphatic malformations
  • known allergy to one of the constituents of Onreltea
  • pregnancy, or sexually active subjects of child-bearing potential (CBP), unwilling to use contraception during the study (such as barrier method, or oral contraceptives).

Trial locations and contacts

1 site in 1 country.

Canada1 site

  • The Hospital For Sick Children

    Toronto, Ontario, M5G1X8

Other trials in Canada

About this study

Official title: Onreltea (Brimonidine) Gel In Pediatric Patients With Capillary Malformations: A Prospective, Open-label, Cohort Study

Capillary Malformations (CM) affect a significant proportion of otherwise healthy children and may lead to psychological discomfort if left untreated. A significant proportion of untreated lesions undergo soft tissue thickening and darker discoloration later in life due to progressive ectasia of the affected vessels. While laser treatment is available, its use may be limited due to need for repeated sedation/general anesthetic use, partial response and cost.

The investigators propose to conduct an open-label, prospective, cohort study using Onreltea ( Brimonidine) gel for treatment of facial capillary malformations in children. The study medication will be applied topically on affected area of the skin daily for 12 weeks. Follow up visits will occur at at Week 1,4,8,12, and 16 to assess the efficacy and safety of the proposed treatment.

The study second aim is to explore the feasibility of conducting a multicenter placebo controlled study.

Read the detailed description

The investigators are planning to enroll in the study 20 participants at SickKids.

It is a prospective, open label, cohort study. Patients enrolled in the study will be followed at the Hospital For Sick Children for 16 weeks. They will come for the study visits 6 times: in 1 week, 4,8,12, and 16 weeks after the treatment has been started. During each study visit the study investigators will assess any changes in the characteristics of CM lesion(s) captured by a Chromometer *, Analogue Scale and Erythema Assessment tools. Participants or their parents will assess the changes at the final study visit (VAS and EA tools).

Patients will be provided with study medication for all duration of the study treatment (12 weeks).

The results of the treatment will be compared with the baseline data to evaluate the efficacy and safety of Onreltea (Brimonidine) gel in children with facial capillary malformations.

Being tested
Brimonidine 0.33% gel
Keywords
Capillary malformations, Onrealtea, port-wine stain, treatment, topical
Medical subject headings
Capillary Malformations, Congenital, 1, Port-Wine Stain

What participants receive

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

  • Brimonidine 0.33% gelDrug

    Also called Onreltea

    Topical application of Brimonidine 0.33% gel on Capillary Malformation (CM) lesion once daily for 12 weeks

Study groups in NCT02764411
Study groupRoleWhat they receive
Onreltea ( Brimonidine)ExperimentalAll the patients enrolled in the study will apply Onreltea ( Brimonidine 0.33%) gel on the affected skin area for 12 weeks (from Day 0 to Week 12 visit).
Receives: Drug: Brimonidine 0.33% gel

What is being measured

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

  1. The change in the color of the capillary malformation using Chroma meter values (Δa, ΔE) at 12 weeks.

    Measurement of erythema will be performed using Chroma Meter, CR-400, Konica, Minolta, Osaka, Japan. The meter readings will result in 3 values: L- refers to the relative light intensity, ranging from 0 (black) to +100 (white); a-captures color saturation, ranging from +60 (green) to -60 (red) and b- captures color spectrum from +60 (blue) to -60 (yellow). In most studies both, changes in a (Δa) and overall changes in the composite score (ΔE calculated as √((ΔL*before-ΔL*after)^2+(Δa*before-Δa*after)^2+(Δb*before-ΔL*after)^2 ) are obtained.

    Measured: 12 weeks

Secondary outcomes (6)

  1. Changes in the color of the lesion (Δa, ΔE) at each follow up visit including the last visit at 16 weeks compared to baseline

    Same as in primary outcome measure

    Measured: 1,4,8,16 weeks

  2. Changes in CEA scores at 12, 16 weeks compared to baseline

    A Clinician Erythema Assessment scale (CEA), consisting of a 0-4 numerical scale as follows:

    0- clear skin, no erythema

    1. almost clear skin, slight redness
    2. mild erythema, definite redness
    3. moderate erythema, marked redness
    4. severe erythema, fiery redness

    Measured: 12 and 16 weeks

  3. Changes in the iVAS at 12 and 16 weeks compared to baseline

    Investigator's assessment of changes on the Visual Analogue Scale ( iVAS)

    Measured: 12 and 16 weeks

  4. Correlation between iVAS, pVAS, CEA, pEA and Chroma Meter values

    pVAS - patient/parent's Visual Analogue Scale assessment; pEA- patient/parent Erythema Assessment

    Measured: 1,4,8,12,16 weeks

  5. Percentage of patients achieving 75% and 100% resolution of the lesion

    by iVAS and chromo meter values

    Measured: 12 weeks

  6. Frequency of observed and reported adverse events (AE)

    AE documented in patient diary and mentioned at each study visit

    Measured: 16 weeks

Timeline

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

  1. First posted6 May 2016 (estimated)
  2. Study startJun 2016
  3. Primary completionOct 2018
  4. Study completionOct 2018

Why it stopped: Poor enrollment, lack of feasibility

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 3
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
6 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02764411
Sponsor's protocol ID
1000051364
Status last verified
Apr 2019
First submitted
19 Apr 2016
Last updated
16 Apr 2019
Results posted
No
Data monitoring committee
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Brimonidine 0.33% gel in people with Capillary Malformations, run by The Hospital for Sick Children at 1 site in Canada.

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 5 inclusion and 9 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: stopped early, as of the sponsor's last update on 16 Apr 2019. 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 Canada. 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.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

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 was stopped early (reason given: Poor enrollment, lack of feasibility). Results are not available in the source record.

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?

The change in the color of the capillary malformation using Chroma meter values (Δa, ΔE) at 12 weeks. (time frame: 12 weeks). 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 NCT02764411.

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 16 Apr 2019.

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