Onreltea (Brimonidine) Gel In Pediatric Patients With Capillary Malformations
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|ClinicalTrials.gov Identifier: NCT02764411|
Recruitment Status : Recruiting
First Posted : May 6, 2016
Last Update Posted : April 19, 2018
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.
|Condition or disease||Intervention/treatment||Phase|
|Capillary Malformations||Drug: Brimonidine 0.33% gel||Phase 3|
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 (Clinical Trial)|
|Estimated Enrollment :||20 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Onreltea (Brimonidine) Gel In Pediatric Patients With Capillary Malformations: A Prospective, Open-label, Cohort Study|
|Actual Study Start Date :||June 2016|
|Estimated Primary Completion Date :||December 2018|
|Estimated Study Completion Date :||December 2018|
Experimental: Onreltea ( Brimonidine)
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).
Drug: Brimonidine 0.33% gel
Topical application of Brimonidine 0.33% gel on Capillary Malformation (CM) lesion once daily for 12 weeks
Other Name: Onreltea
- The change in the color of the capillary malformation using Chroma meter values (Δa, ΔE) at 12 weeks. [ Time Frame: 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.
- Changes in the color of the lesion (Δa, ΔE) at each follow up visit including the last visit at 16 weeks compared to baseline [ Time Frame: 1,4,8,16 weeks ]Same as in primary outcome measure
- Changes in CEA scores at 12, 16 weeks compared to baseline [ Time Frame: 12 and 16 weeks ]
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 [ Time Frame: 12 and 16 weeks ]Investigator's assessment of changes on the Visual Analogue Scale ( iVAS)
- Correlation between iVAS, pVAS, CEA, pEA and Chroma Meter values [ Time Frame: 1,4,8,12,16 weeks ]pVAS - patient/parent's Visual Analogue Scale assessment; pEA- patient/parent Erythema Assessment
- Percentage of patients achieving 75% and 100% resolution of the lesion [ Time Frame: 12 weeks ]by iVAS and chromo meter values
- Frequency of observed and reported adverse events (AE) [ Time Frame: 16 weeks ]AE documented in patient diary and mentioned at each study visit
- 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 [ Time Frame: 12 weeks ]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.
- Percentage difference in Chroma Meter values (L -relative light intensity, a - color saturation, b - color spectrum) between treated and untreated lesions (control) [ Time Frame: 1,4,8,12 and 16 weeks ]
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%
- 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 ]Percentage of patients experiencing flare-up (defined as reoccurrence of the red discoloration) at the end of the study (16 weeks)
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02764411
|Contact: Elena Pope, MD||416-813-6883||Elena.Pope@sickkids.ca|
|Contact: Irene Lara-Corrales, MD||416-813-4864||Irene.Lara-Corrales@sickkids.ca|
|The Hospital For Sick Children||Recruiting|
|Toronto, Ontario, Canada, M5G1X8|
|Contact: Elena Pope, MD 416-813-7835 Elena.Pope@sickkids.ca|
|Contact: Hanna Fadzeyeva 416-813-7835 Hanna.Fadzeyeva@sickkids.ca|
|Sub-Investigator: Irene Lara Corrales, MD|
|Principal Investigator:||Elena Pope, MD||The Hospital for Sick Children|