Onreltea (Brimonidine) Gel In Pediatric Patients With Capillary Malformations

The Hospital for Sick Children

Status and phase: Terminated; Phase 3

Conditions: Capillary Malformations

Treatments: Drug: Brimonidine 0.33% gel

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT02764411

1000051364

Details and patient eligibility

About

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.

Full 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.

Enrollment: 6 patients

Sex: All

Ages: 12 to 17 years old

Volunteers: No Healthy Volunteers

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).

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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6 participants in 1 patient group

Onreltea ( Brimonidine)

Experimental group

Description:

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).

Treatment:

Drug: Brimonidine 0.33% gel