Onreltea (Brimonidine) Gel In Pediatric Patients With Capillary Malformations

• Status: Terminated
• Trial end date: 2018-10-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: The Hospital for Sick Children
• Collaborator: Galderma Laboratories, L.P.
• Treatments: Brimonidine Tartrate

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).