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Onreltea (Brimonidine) Gel In Pediatric Patients With Capillary Malformations

NCT02764411 · Status: TERMINATED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 6

Last updated 2019-04-16

No results posted yet for this study

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.

Conditions

  • Capillary Malformations

Interventions

DRUG

Brimonidine 0.33% gel

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

Sponsors & Collaborators

  • Galderma R&D

    collaborator INDUSTRY

  • The Hospital for Sick Children

    lead OTHER

Principal Investigators

  • Elena Pope, MD · The Hospital for Sick Children

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
12 Years
Max Age
17 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-06-30
Primary Completion
2018-10-31
Completion
2018-10-31

Countries

  • Canada

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02764411 on ClinicalTrials.gov