Topical timolol maleate gel for non-complicated superficial infantile haemangiomas

Topical timolol maleate gel for the reduction in colour and size of non-complicated superficial infantile haemangiomas.

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ANZCTR

Registry ID

ACTRN12610001069044

Enrollment

Registered

2010-12-06

Start date

2011-02-01

Completion date

Unknown

Last updated

2020-01-13

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

Conditions

None listed

Brief summary

Non-complicated infantile haemangiomas have been followed up with minimal intervention because of spontaneous involution. However the involution phase is slow and most children go to school with a disfiguring infantile haemangioma. Propranolol has been observed to accelerate the involution phase and a small retrospective chart review and a single case report have suggested that topical timolol maleate gel 0.5% may reduce the proliferative phase of smal and superficial infantile haemangiomas with reduced systemic complications.

Interventions

Timolol maleate gel 0.5% one drop applied to the cutaneous ,small (<5cm), superficial infantile haemangioma twice daily for 24 weeks

Study design

Allocation

Randomised controlled trial

Intervention model

Parallel

Primary purpose

Treatment

Masking

Blinded (masking used)

Eligibility

Sex/Gender

All

Age

5 Weeks to 24 Weeks

Healthy volunteers

Inclusion criteria

infantile haemangiomas <5 cm

Exclusion criteria

PHACE syndrome lesions >5cm diametre deep subcutaneous lesions <5 weeks old >24 weeks old

Outcome results