NCT02764411|TerminatedPhase 3
Study Stopped
Poor enrollment, lack of feasibility
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Sponsor study identifier
interventional
6
1 country
1
Study Start
June 2016
Actual (reported)Primary Completion
October 2018
Actual (reported)Study Completion
October 2018
Actual (reported)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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
October 2018
Actual (reported)Click on a node to explore related trials.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
April 19, 2016
Actual (reported)May 6, 2016
Actual (reported)June 2016
Actual (reported)October 2018
Actual (reported)October 2018
Actual (reported)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.
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
1,4,8,16 weeks
Changes in CEA scores at 12, 16 weeks compared to baseline
12 and 16 weeks
Changes in the iVAS at 12 and 16 weeks compared to baseline
12 and 16 weeks
Correlation between iVAS, pVAS, CEA, pEA and Chroma Meter values
1,4,8,12,16 weeks
Percentage of patients achieving 75% and 100% resolution of the lesion
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
12 weeks
Percentage difference in Chroma Meter values (L -relative light intensity, a - color saturation, b - color spectrum) between treated and untreated lesions (control)
1,4,8,12 and 16 weeks
Percentage of patients experiencing flare-up (defined as reoccurrence of the red discoloration) at the end of the study (16 weeks)
16 weeks
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).
Topical application of Brimonidine 0.33% gel on Capillary Malformation (CM) lesion once daily for 12 weeks
The Hospital For Sick Children
Toronto, Ontario, M5G1X8, Canada
Elena Pope, MD
The Hospital for Sick Children
6 participants (actual enrollment reported by the registry).
First Submitted
April 19, 2016
First Posted
May 6, 2016
Study Start
June 2016
Actual (reported)Contact the study team to confirm eligibility.
Primary Completion
October 2018
Actual (reported)Study Completion
October 2018
Actual (reported)Last Updated
April 16, 2019
Record last verified: 2019-04
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Source: ClinicalTrials.gov.
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