Study to evaluate efficacy and safety of topical administration of timolol maleate 0.5% solution in the treatment of Child Proliferative Hemangioma Early Stage Surface

Phase 1

• Conditions: Therapeutic area: Diseases [C] - Skin and Connective Tissue Diseases [C17]; Children Superficial Hemangioma

• Registration Number: EUCTR2013-005199-17-ES
• Lead Sponsor: Institut de Recerca HSCSP

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2014-04-25
• Last Update Posted: 10 December 2019

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: Not specified
• Target Recruitment: 70

Inclusion Criteria

- Informed Consent signed by a parent or guardian of the patient, both for study participation and for taking pictures.
- The patient is 10 to 60 days old at the time of inclusion.
- The patient should have at least:
- A mixed both surface, sized from 0.3 to 5 cm in any location of the body surface focal or segmental hemangioma.; or
- A hemangioma precursor defined as pink macules with white halo in periphery, clinically characteristic of the precursors of hemangiomas in infancy; or
- A abortion or minimum defined as angiomas proliferation telangiectatic Hemangioma showing proliferation in <5% of the surface of the hemangioma
Are the trial subjects under 18? yes
Number of subjects for this age range: 70
F.1.2 Adults (18-64 years) no
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

- Patients under 10 and over 60 days old at the time of inclusion.
- Patients with indication of systemic therapy (ulcerated hemangiomas in mucosal surfaces, disfiguring)
- Patients who are with another treatment modality for hemangiomas (beta blockers, corticosteroids, interferon, cyclophosphamide, vincristine)
- Hemangiomas associated syndromes (PHACE, LUMBAR, SACRAL, PELVIS)
- Hemangiomas affecting any organ or airway
- Hemangiomas affecting any organ or airway
- Patients with any underlying disease (bronchial asthma, severe lung disease, sinus bradycardia, atrioventricular block second degree, third degree, overt heart failure or cardiogenic shock).
- Patients with congenital defects (patients with a chromosomal syndrome, patients with congenital heart disease (tetralogy of Fallot, transposition of the great arteries, ventricular septal defect, atrial septal defect, persistent ductus arteriosus)
- Patients with neoplastic disease (leukemias, sarcomas, neuroblastoma, retinoblastoma, etc.)
- Hypersensitivity to the active substance or any of the excipients.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified