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Alpha-2 Adrenergic Agonist

Onreltea ( Brimonidine) for Port-Wine Stain

Phase 3
Waitlist Available
Led By Elena Pope, MD
Research Sponsored by The Hospital for Sick Children
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be younger than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 1,4,8,12,16 weeks
Awards & highlights

Study Summary

This trial aims to study the use of Onreltea gel to treat facial capillary malformations in children, which can lead to psychological discomfort if untreated. Follow-up visits will assess efficacy and safety of the proposed treatment. A placebo-controlled study is also being explored.

Eligible Conditions
  • Port-Wine Stain

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~1,4,8,12,16 weeks
This trial's timeline: 3 weeks for screening, Varies for treatment, and 1,4,8,12,16 weeks for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
The change in the color of the capillary malformation using Chroma meter values (Δa, ΔE) at 12 weeks.
Secondary outcome measures
Changes in CEA scores at 12, 16 weeks compared to baseline
Changes in the color of the lesion (Δa, ΔE) at each follow up visit including the last visit at 16 weeks compared to baseline
Changes in the iVAS at 12 and 16 weeks compared to baseline
+3 more
Other outcome measures
Percentage difference in Chroma Meter values (L -relative light intensity, a - color saturation, b - color spectrum) between treated and untreated lesions (control)
Percentage of patients experiencing flare-up (defined as reoccurrence of the red discoloration) at the end of the study (16 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

Side effects data

From 2013 Phase 4 trial • 376 Patients • NCT02003534
6%
Conjunctiva Hyperemia
100%
80%
60%
40%
20%
0%
Study treatment Arm
0.15% Brimonidine Tartrate

Trial Design

1Treatment groups
Experimental Treatment
Group I: Onreltea ( Brimonidine)Experimental Treatment1 Intervention
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).

Find a Location

Who is running the clinical trial?

Galderma R&DIndustry Sponsor
299 Previous Clinical Trials
60,414 Total Patients Enrolled
The Hospital for Sick ChildrenLead Sponsor
692 Previous Clinical Trials
6,946,594 Total Patients Enrolled
2 Trials studying Port-Wine Stain
94 Patients Enrolled for Port-Wine Stain
Elena Pope, MDPrincipal InvestigatorThe Hospital for Sick Children
4 Previous Clinical Trials
40 Total Patients Enrolled
1 Trials studying Port-Wine Stain
20 Patients Enrolled for Port-Wine Stain

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Recent research and studies
clinicaltrials.govStudy
Onreltea (Brimonidine) Gel In Pediatric Patients With Capillary Malformations
Elena Pope 2016. "Onreltea (Brimonidine) Gel In Pediatric Patients With Capillary Malformations". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT02764411.
~1 spots leftby May 2025
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