Randomised controlled trial: Can topical timolol maleate prevent complications and reduce the need for further treatment for small superficial infantile haemangiomata in high risk areas?
- Conditions
- Infantile HaemangiomaSkin - Dermatological conditions
- Registration Number
- ACTRN12619001685101
- Lead Sponsor
- nited Christian Hospital
- Brief Summary
The study was the first Chinese study to define the role of topical timolol maleate (TTM) in the treatment of infantile haemangiomata (IH). Our team included all <1-year-old infants within a 13-month period presenting with small (<2cm) superficial IH located at high risk areas (i.e. tip of ears, tip of nose, eyelids, acral areas, facial areas, scalp, neck, buttocks, perineum and axilla). Patients either received 12 months of 0.5% timolol maleate solution (study group) or watchful waiting (control group). Both groups were monitored and treated similarly. The primary outcome was IH with development of complications that required additional interventions. The secondary outcomes included side effects of TTM and change in IH size. 42 children were eligible to the study. Patients who received TTM were noted to have significantly fewer complications than the control group (4.2% vs 29%). Mean IH volume percentage reduction was significantly more for the TTM group and no-TTM group at 3 months, 6 months and 12 months after study uptake. We concluded that TTM is an effective and safe treatment option to reduce complications, IH volume and the need for further intervention for infants with small superficial infantile haemangioma located at high risk areas.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- All
- Target Recruitment
- 41
Chinese patients, patients less than 1 year old at first consultation within the study period, superficial infantile haemangioma (IH), IH less than 2cm in its longest diameter, and IH located in high risk areas (that is, tip of ears, tip of nose, eyelids, acral areas, facial areas, scalp, neck, buttocks, perineum and axilla).
Patients with pre-treated IH, IH with mixed or deep components, non-infantile haemangiomata such as non-involuting congenital haemangiomata (NICH), syndromal haemangiomata (e.g. PHACES syndrome), and IH that are already complicated or ulcerated at first consultation.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Data-linkage to medical records and direct clinical assessment by doctors at outpatient clinic for complications. <br><br>Complications include rapid increase in size (>150% per month increase in volume), development of ulceration, or impairment of vital functions of infantile haemangioma. The lesions are measured using a ruler for its size. The other parameters can be seen directly with the naked eye.[At baseline, 1 month, 3 months, 6 months and 12 months (primary endpoint) after randomisation];Data-linkage to medical records and direct clinical assessment by doctors at outpatient clinic for any further treatment required.<br><br>Further treatment include oral propranolol, laser therapy, corticosteroid injection or surgical excision. Decision is based on development of complications which in turn aligns to HK, US and UK protocols.[At baseline, 1 month, 3 months, 6 months and 12 months (primary endpoint) after randomisation]
- Secondary Outcome Measures
Name Time Method Data-linkage to medical records and direct clinical assessment by doctors at outpatient clinic for any reported side effects of topical timolol maleate by the carers of the child.[At baseline, 1 month, 3 months, 6 months and 12 months after randomisation.];Size in terms of length, width and thickness of haemangioma measured with paper measuring ruler and documented with photo[At baseline, 1 month, 3 months, 6 months and 12 months after randomisation.]