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Clinical Trials/ACTRN12619001370190
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.

Gillies McIndoe Research Institute0 sites50 target enrollmentStarted: October 8, 2019Last updated:

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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