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Onreltea (Brimonidine) Gel In Pediatric Patients With Capillary Malformations

Primary Purpose

Capillary Malformations

Status

Terminated

Phase

Phase 3

Locations

Canada

Study Type

Interventional

Intervention

Brimonidine 0.33% gel

About this trial

This is an interventional treatment trial for Capillary Malformations focused on measuring Capillary malformations, Onrealtea, port-wine stain, treatment, topical

Eligibility Criteria

12 Years - 17 Years (Child)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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

Exclusion Criteria:

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)
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).

Sites / Locations

The Hospital For Sick Children

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Onreltea ( Brimonidine)

Arm Description

All 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).

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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

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 almost clear skin, slight redness mild erythema, definite redness moderate erythema, marked redness severe erythema, fiery redness

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

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

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

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

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

by iVAS and chromo meter values

Frequency of observed and reported adverse events (AE)

AE documented in patient diary and mentioned at each study visit

Full Information

NCT ID

NCT02764411

First Posted

April 19, 2016

Last Updated

April 12, 2019

Sponsor

The Hospital for Sick Children

Collaborators

Galderma R&D

1. Study Identification

Unique Protocol Identification Number

NCT02764411

Brief Title

Onreltea (Brimonidine) Gel In Pediatric Patients With Capillary Malformations

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

April 2019

Overall Recruitment Status

Terminated

Why Stopped

Poor enrollment, lack of feasibility

Study Start Date

June 2016 (Actual)

Primary Completion Date

October 2018 (Actual)

Study Completion Date

October 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

The Hospital for Sick Children

Collaborators

Galderma R&D

4. Oversight

Data Monitoring Committee

5. Study Description

Brief 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. 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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Capillary Malformations

Keywords

Capillary malformations, Onrealtea, port-wine stain, treatment, topical

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 3

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

6 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Onreltea ( Brimonidine)

Arm Type

Experimental

Arm Description

All 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).

Intervention Type

Drug

Intervention Name(s)

Brimonidine 0.33% gel

Other Intervention Name(s)

Onreltea

Intervention Description

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

Primary Outcome Measure Information:

Title

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

Description

Time Frame

12 weeks

Secondary Outcome Measure Information:

Title

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

Description

Same as in primary outcome measure

Time Frame

1,4,8,16 weeks

Title

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

Description

Time Frame

12 and 16 weeks

Title

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

Description

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

Time Frame

12 and 16 weeks

Title

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

Description

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

Time Frame

1,4,8,12,16 weeks

Title

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

Description

by iVAS and chromo meter values

Time Frame

12 weeks

Title

Frequency of observed and reported adverse events (AE)

Description

AE documented in patient diary and mentioned at each study visit

Time Frame

16 weeks

Other Pre-specified Outcome Measures:

Title

Predictors for a good response, defined as at least 50 % change in the erythema measured using Chroma Meter (a* after compared to a* before) at 12 weeks mark

Description

Predictors for a good response, defined as at least 50 % change in the erythema measured using Chroma Meter (a* after compared to a* before) at 12 weeks mark. Percent of participants with predictors for a good response.

Time Frame

12 weeks

Title

Percentage difference in Chroma Meter values (L -relative light intensity, a - color saturation, b - color spectrum) between treated and untreated lesions (control)

Description

Changes in value ( e.g. "a") between baseline and Week *, calculated in % for investigational lesion, minus changes in value "a" between baseline and Week * , calculated in % for the control lesion. (a (inv.Week*) - a (inv. Baseline)/ a (inv. Baseline)) x 100% -- (a (contr. Week*) - a (contr. Baseline)/ a ( contr. baseline)) x 100%

Time Frame

1,4,8,12 and 16 weeks

Title

Percentage of patients experiencing flare-up (defined as reoccurrence of the red discoloration) at the end of the study (16 weeks)

Description

Percentage of patients experiencing flare-up (defined as reoccurrence of the red discoloration) at the end of the study (16 weeks)

Time Frame

16 weeks

10. Eligibility

Sex

All

Minimum Age & Unit of Time

12 Years

Maximum Age & Unit of Time

17 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: 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 Exclusion Criteria: 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) 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).

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Elena Pope, MD

Organizational Affiliation

The Hospital for Sick Children

Official's Role

Principal Investigator

Facility Information:

Facility Name

The Hospital For Sick Children

City

Toronto

State/Province

Ontario

ZIP/Postal Code

M5G1X8

Country

Canada

12. IPD Sharing Statement

Plan to Share IPD

Learn more about this trial

Onreltea (Brimonidine) Gel In Pediatric Patients With Capillary Malformations

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