Hemangioma
Conditions
Brief 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).
Interventions
DRUGTimolol
The patient will be treated with 2 drops twice a day over the lesion and rub with the finger (no occlusive) for 24 weeks
DRUGPlacebo
The patient will be treated with 2 drops twice a day over the lesion and rub with the finger (no occlusive) for 24 weeks
Sponsors
Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Investigator)
Eligibility
Sex/Gender
ALL
Age
10 Days to 60 Days
Healthy volunteers
No
Inclusion criteria
* Written informed consent for study participation and the use of the patient's photographs from the patient's parent(s) or guardian(s), * The patient is between 10 and 60 days of age at the time of enrollment, * The patient should have: * at least one focal or segmental hemangioma, mixed or superficial, present anywhere on the body of at least 0.3 cm of minimum diameter and not greater of 5 cm. * abortive or minimal growth hemangioma * Infantile hemangioma precursors
Exclusion criteria
* Patients \> 60 days of age * Complicated hemangiomas (life-threatening, function-threatening, or ulcerated) * Children who have previously received systemic, intra-lesional or topical corticosteroids, imiquimod, vincristine, alpha-interferon, propranolol or other beta blockers, PDL laser. * Patients with PHACES, LUMBAR, SACRAL or PELVIS syndrome. * Internal involvement hemangiomas (liver, GI tract, larynx) * Children with a personal history of asthma or cardiac conditions that may predispose to heart block. * Children with congenital birth defects * Children with Cancer (leukemia, sarcoma, neuroblastoma, retinoblastoma) * Children with a history of hypersensitivity to beta blockers or excipients.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Complete or almost complete resolution of the lesions | 24 weeks | Efficacy to treatment at 24 weeks, categorized as complete or almost complete resolution of the lesions (almost complete resolution defined as faint macular erythema, telangiectasia and no palpable component). This will be generated by independent blind evaluations by comparing photographs at baseline and 24 weeks. The investigators will score this improvement into one of the following categories (complete resolution, improve, stabilization, worsening) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Adverse reactions | 24 weeks | Evaluation of safety and adverse reactions. The investigators will monitor vital signs of the patients every follow-up visit and ask the caretakers about side effects and adverse reactions to treatment. |
Countries
Spain
Outcome results
None listed