RecruitingPhase 2ACTRN12619001370190

Treatment of Superficial Strawberry Birthmarks with Topical Timolol

Topical Timolol Treatment of Superficial Proliferating Infantile Haemangioma assessing the effectiveness of 0.5% topical timolol gel in the treatment of superficial IH.

Sponsor

Gillies McIndoe Research Institute

Enrollment

50 participants

Start Date

Aug 31, 2018

Study Type

Interventional

Conditions

Infantile Haemangioma

Summary

Most IHs do not require active treatment as they involute spontaneously over time. Up to 10-15% of IHs are problematic and require intervention during infancy- with the mainstay treatment being oral propanolol. Complications of propranolol treatment of IH have been reported in up to 31% of patients in a large meta-analysis, and therefore its use is restricted to problematic IHs. However, following spontaneous involution, many of the IH lesions can cause permanent cosmetic blemish, Timolol maleate is a topical ß-blocker that has been used for the treatment of glaucoma in the paediatric population for over 30 years. Research is yet to define the optimal duration of topical treatment of IH, with studies treating patients from 24 weeks up to 10 months, or until satisfactory improvement was noted. The best outcomes for topical timolol appears to be in patients with superficial IH who used the 0.5% timolol solution for a period of at least three months.This study investigates the efficacy of 0.5% topical timolol gel for the treatment of superficial IHs.

Eligibility

Sex: Both males and femalesMin Age: 1 MonthsMax Age: 10 Monthss

Plain Language Summary

Simplified for easier understanding

Infantile haemangiomas (IHs) — commonly called strawberry birthmarks — are the most common benign tumours in infants. They appear in the first few weeks of life and typically grow for a few months before gradually fading on their own over several years. While most do not require treatment, those in sensitive areas like the face, neck, or genitals can cause cosmetic or functional concerns. Oral propranolol is the standard treatment for problematic birthmarks but comes with some risks, particularly for heart and breathing function in very young babies. This trial is studying whether a topical gel — timolol maleate 0.5%, applied directly to the skin — can effectively treat superficial strawberry birthmarks in infants who are not suitable for oral propranolol. Timolol belongs to the same family of drugs as propranolol but is applied topically, which may reduce systemic side effects. The gel has been used safely in infants for glaucoma for many years. Your baby may be eligible if they have a superficial infantile haemangioma in a cosmetically or functionally sensitive area, are between 1 and 10 months old, weigh at least 3.5 kg, and are not suitable for oral propranolol. Birthmarks near the eyes, mouth, or anus, and those larger than 9 cm², are excluded. This is a gentle, non-invasive option for families managing visible birthmarks in their infant.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

This is an open labelled phase II study assessing the effectiveness of 0.5% topical timolol gel in the treatment of superficial infantile haemangiomas (IHs) . Most IHs do not require active treatmen

This is an open labelled phase II study assessing the effectiveness of 0.5% topical timolol gel in the treatment of superficial infantile haemangiomas (IHs) . Most IHs do not require active treatment as they involute spontaneously over time. However, up to 10-15% of IH require intervention during infancy because they cause complications, such as visual and airway obstruction, ulceration, bleeding, and permanent disfigurement. Following spontaneous involution, approximately 50% of the lesions will leave a blemish, and half of these will require treatment. Currently propanolol is the mainstay treatment of problematic IHs. We have demonstrated that oral propranolol at 1.5–2 mg/kg/day is an effective and safe treatment for problematic proliferating IH. However, many of the untreated IH can cause permanent cosmectic blemish, affecting the skin and/or leaving subcutaneous fatty residuum following spontaneous involution. Earlier treatment (during the early proliferative phase) has been shown to result in better outcomes and reduced short and long-term complications. Parents/caregivers will be shown how to apply this gel to the IH. 1 drop morning and night applied topically to the IH. Treatment will be increased to 1 drop three times a day, morning,noon and night, after 2 months if there is no improvement and there are no adverse effects. Treatment is continued until complete resolution of the lesion occurs, there is no change in lesion size, colour or consistency after 3 months of continued use, until the patient reaches 12 months of age, or if any criteria for removal from the study are met.

Locations(1)

New Zealand

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ACTRN12619001370190