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.
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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
6
Topical application of Brimonidine 0.33% gel on Capillary Malformation (CM) lesion once daily for 12 weeks
The Hospital For Sick Children
Toronto, Ontario, Canada
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.
Time frame: 12 weeks
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
Time frame: 1,4,8,16 weeks
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
Time frame: 12 and 16 weeks
Changes in the iVAS at 12 and 16 weeks compared to baseline
Investigator's assessment of changes on the Visual Analogue Scale ( iVAS)
Time frame: 12 and 16 weeks
Correlation between iVAS, pVAS, CEA, pEA and Chroma Meter values
pVAS - patient/parent's Visual Analogue Scale assessment; pEA- patient/parent Erythema Assessment
Time frame: 1,4,8,12,16 weeks
Percentage of patients achieving 75% and 100% resolution of the lesion
by iVAS and chromo meter values
Time frame: 12 weeks
Frequency of observed and reported adverse events (AE)
AE documented in patient diary and mentioned at each study visit
Time frame: 16 weeks
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