Onreltea (Brimonidine) Gel In Pediatric Patients With Capillary Malformations
Status:
Terminated
Trial end date:
2018-10-01
Target enrollment:
Participant gender:
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.