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Treatment of Cutaneous Hemangioma of Infancy With Topical 0.5% Timolol Maleate Eye Drop Compared With Placebo in Pediatric Patients, Siriraj Hospital


Phase 3
N/A
2 Years
Open (Enrolling)
Both
Hemangioma

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Trial Information

Treatment of Cutaneous Hemangioma of Infancy With Topical 0.5% Timolol Maleate Eye Drop Compared With Placebo in Pediatric Patients, Siriraj Hospital


Inclusion Criteria:



- Patient who is less than 2 years

- Patient who has been diagnosed with superficial infantile hemangioma

- The tumor which has been in proliferative or plateau phase

- There is no indication for systemic treatment

- Informed consent is obtained from the parent of the patient

Exclusion Criteria:

- Patient who has the indication for systemic therapy

- Patient who is treated by the other modality such as laser treatment

- Patient who has underlying disease treated by beta blocker, corticosteroids,
interferon, cyclophosphamide or vincristine

- Patient who has history of hypersensitivity reaction to beta blocker, asthma, cardiac
condition prove to heart block

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Outcome Measure:

Efficacy of the topical 0.5% timolol maleate solution in treatment of infantile hemangioma compared to placebo

Outcome Description:

Percent changes in visual analogue scale of the lesion color and global assessment scale of the lesion after treatment

Outcome Time Frame:

6 months

Safety Issue:

No

Authority:

Thailand: Ethical Committee

Study ID:

088/2555(EC4)

NCT ID:

NCT01685398

Start Date:

September 2012

Completion Date:

June 2015

Related Keywords:

  • Hemangioma
  • Hemangioma
  • Hemangioma, Capillary

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