NCT02731287

Topical Timolol for Infantile Hemangioma in Early Proliferative Phase

Efficacy and Safety of Topical Timolol Maleate 0.5% Solution for Superficial Infantile Hemangioma in Early Proliferative Phase. A Randomized Clinical Trial

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 70 (actual)
• Sponsor: Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau · Academic / Other
• Sex: All
• Age: 10 Days – 60 Days
• Healthy volunteers: Not accepted

Summary

Infantile hemangioma (IH) is the most common benign vascular tumor in pediatric population. Oral propranolol is the treatment of choice for complicated hemangiomas. Topical timolol, a non-selective beta-blocker, is an emerging treatment which has been reported to be effective and safe for the treatment of IH, especially for superficial hemangiomas. Investigators hypothesize that treatment with topical timolol in the first two months of life, before the proliferative phase or in early proliferative phase, may prevent from further growing and the need to treat with oral propranolol.

Detailed description

A multicentric, randomized, double-blind, placebo-controlled, phase II clinical trial to evaluate the efficacy and safety of 0.5% timolol maleate solution for the early treatment of infantile hemangioma. Patients with less of 60 days of life with focal or segmental hemangiomas, superficial, mixed or abortive will be treated with topical timolol 0.5% twice a day for 24 weeks. Changes in lesion size, color and thickness will be evaluated from photographs taken at 2,4,8,12,24 and 36 weeks. Vital signs and side effects will be recorded at each visit. Response to treatment will be evaluated by a blinded investigator in a semiquantitative scale (complete resolution, improve, stabilization, worsening).

Conditions

• Hemangioma

Interventions

Type	Name	Description
DRUG	Timolol	The patient will be treated with 2 drops twice a day over the lesion and rub with the finger (no occlusive) for 24 weeks
DRUG	Placebo	The patient will be treated with 2 drops twice a day over the lesion and rub with the finger (no occlusive) for 24 weeks

Timeline

• Start date: 2014-03-01
• Primary completion: 2017-01-01
• Completion: 2017-03-01
• First posted: 2016-04-07
• Last updated: 2018-11-14

Locations

2 sites across 1 country: Spain