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

Efficacy and safety of topical administration of timolol maleate 0.5% solution in the treatment of Child Proliferative Hemangioma Early Stage Surface. Randomized Controlled Study

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2013-005199-17-ES

Enrollment

Registered

2014-04-25

Start date

2014-07-16

Completion date

Unknown

Last updated

2019-12-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Children Superficial Hemangioma

Interventions

Trade Name: Cusimolol Pharmaceutical Form: Eye drops, solution INN or Proposed INN: TIMOLOL CAS Number: 26921-17-5 Other descriptive nam

Eligibility

Sex/Gender

All

Inclusion criteria

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 =65 years) no F.1.3.1 Number of subjects for this age range

Exclusion criteria

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.

Design outcomes

Primary

Measure	Time frame
Main Objective: To determine the efficacy of timolol maleate 0.5% solution in the treatment of infantile hemangiomas surface during the early proliferative stage.; Secondary Objective: - To analyze the effectiveness of timolol maleate 0.5%, expressed as complete / almost complete resolution of the HI at week 4, 12 and 24 compared to baseline. - To analyze the effectiveness of timolol maleate 0.5% by qualitative assessments in the center by parents or guardians - To analyze the persistence of efficacy 12 weeks after end of treatment - To analyze the safety profile and local tolerability of timolol maleate 0.5% solution in the treatment of HI ;Primary end point(s): The primary endpoint for evaluating the efficacy of treatment is complete / almost complete resolution of the HI target at week 24 of treatment, which is defined as complete resolution of the lesion complete improvement and almost complete resolution is defined as the existence of a minimum degree of telangiectasia, erythema, dermal thickening, soft tissue swelling and / or distortion of anatomical references.;Timepoint(s) of evaluation of this end point: 24 weeks	—

Measure

Time frame

Main Objective: To determine the efficacy of timolol maleate 0.5% solution in the treatment of infantile hemangiomas surface during the early proliferative stage.; Secondary Objective: - To analyze the effectiveness of timolol maleate 0.5%, expressed as complete / almost complete resolution of the HI at week 4, 12 and 24 compared to baseline. - To analyze the effectiveness of timolol maleate 0.5% by qualitative assessments in the center by parents or guardians - To analyze the persistence of efficacy 12 weeks after end of treatment - To analyze the safety profile and local tolerability of timolol maleate 0.5% solution in the treatment of HI ;Primary end point(s): The primary endpoint for evaluating the efficacy of treatment is complete / almost complete resolution of the HI target at week 24 of treatment, which is defined as complete resolution of the lesion complete improvement and almost complete resolution is defined as the existence of a minimum degree of telangiectasia, erythema, dermal thickening, soft tissue swelling and / or distortion of anatomical references.;Timepoint(s) of evaluation of this end point: 24 weeks

—

Secondary

Measure	Time frame
Secondary end point(s): - Centralized independent qualitative assessments - Independent qualitative evaluations by the Investigator - Qualitative evaluations by parents / guardians ;Timepoint(s) of evaluation of this end point: 4, 8, 12 and 24 weeks	—

Countries

Spain

Contacts

Public ContactEnrique Peña

Institut de Recerca HSCSP

epenag@santpau.cat34935537636

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026