Onreltea (Brimonidine) Gel In Pediatric Patients With Capillary Malformations

NCT ID: NCT02764411

Last Updated: 2019-04-16

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE3
• Total Enrollment: 6 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-06-30
• Study Completion Date: 2018-10-31

Brief 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.

Detailed Description

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.

Conditions

Capillary Malformations

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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).

Group Type: EXPERIMENTAL

Brimonidine 0.33% gel

Intervention Type: DRUG

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

Interventions

Brimonidine 0.33% gel

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

Intervention Type: DRUG

Other Intervention Names

Onreltea

Eligibility Criteria

Inclusion Criteria

• diagnosis of facial capillary malformation (port-wine stain, PWS) made by a dermatologist
• age: 12-17 years of age
• weight > 45 kg
• lesions with a surface area < 100 cm2
• signed consent and assent for study participation

Exclusion Criteria

• skin breakdown overlying the malformation due to other dermatological conditions (e.g. eczema, psoriasis)
• current or treatment with laser the past 3 months
• other topical treatments used within the past 4 weeks (e.g. rapamycin, corticosteroids, calcineurin inhibitors, etc)
• known chronic renal or hepatic disorders
• known cardiovascular disorders
• other systemic medications that potentially interact with Brimonidine (opiates, chlorpromazine, methyphenidate, reserpine, etc)
• mixed capillary/ venous or lymphatic malformations
• known allergy to one of the constituents of Onreltea
• pregnancy, or sexually active subjects of child-bearing potential (CBP), unwilling to use contraception during the study (such as barrier method, or oral contraceptives).

• Minimum Eligible Age: 12 Years
• Maximum Eligible Age: 17 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Galderma R&D

INDUSTRY

Sponsor Role: collaborator

The Hospital for Sick Children

OTHER

Sponsor Role: lead

Responsible Party

Elena Pope

Professor of Paediatrics, University of Toronto Fellowship Director and Section Head, Paediatric Dermatology.

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Elena Pope, MD

Role: PRINCIPAL_INVESTIGATOR

The Hospital for Sick Children

Locations

The Hospital For Sick Children

Toronto, Ontario, Canada

Countries

Canada

Other Identifiers

1000051364

Identifier Type: -

Identifier Source: org_study_id