ACTRN12619001370190
Recruiting
Phase 2
Topical Timolol Treatment of Superficial Proliferating Infantile Haemangioma assessing the effectiveness of 0.5% topical timolol gel in the treatment ofsuperficial IH.
Overview
- Phase
- Phase 2
- Status
- Recruiting
- Enrollment
- 50
Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Interventional
- Allocation
- Non-randomised trial
- Primary Purpose
- Treatment
- Masking
- Open (masking not used)
Eligibility Criteria
- Ages
- 1 Months to 10 Months (—)
- Sex
- All
Inclusion Criteria
- •Infants referred with a superficial IH(s) in the cosmetic sensitive areas (face and neck), perineum, buttock and axilla, who are not suitable for oral propranolol treatment.
Exclusion Criteria
- •Premature infants (less than 6 weeks corrected gestational age)
- •IH on or near mucosal surface such as the eye, mouth and anus
- •Any single lesion larger than 90mm² (e.g., 3x3cm)
- •Multifocal IHs with a total surface area of more than 90mm²
- •IH with ulceration \>1x1cm
- •IH with thickness \>3mm
- •Subcutaneous IH
- •Any infants with contraindication to ß\-blocker use, e.g.:
- •oCardiac disease including: 2nd or 3rd degree atrioventricular heart block, bradycardia, cardiac failure, cardiogenic shock and congenital heart disease
- •oCongenital hyperthyroidism
Investigators
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