Topical Timolol Gel for the Treatment of Infantile Hemangiomas (NCT02145884) | Clinical Trial Compass
CompletedPhase 2
Topical Timolol Gel for the Treatment of Infantile Hemangiomas
United States26 participantsStarted 2014-05
Plain-language summary
We plan to conduct a study, to see how safe and effective timolol maleate 0.5% gel-forming solution is for infantile hemangiomas (IH) and the response of hemangiomas to timolol maleate 0.5% . Our hypothesis is that timolol will inhibit and possibly reverse growth of appropriate infantile hemangiomas.
Who can participate
Age range7 Days – 6 Months
SexALL
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Inclusion Criteria:
* Written informed permission for study participation and the use of the patient's images are obtained from the patient's parent(s) or guardian(s),
* The patient is between 7 days and 6 months of age at the time of enrollment,
* and a proliferating HOI not requiring systemic therapy is present anywhere on the body, Multiple hemangiomas may be treated on same child, if the hemangioma meets this criteria.
Exclusion Criteria:
* patients who are not otherwise generally healthy;
* at risk for imminent ulceration, life-threatening, function-threatening, or ulcerated;
* patients who have previously received systemic, intra-lesional or topical corticosteroids, imiquimod, vincristine, alpha-interferon, propranolol or other beta blockers;
* patients who have previously been treated for his/her HOI, including any surgical and/or medical procedures;
* patients whose mothers have been breastfeeding the patient while also being treated with beta-blockers, systemic corticosteroids, vincristine or alpha-interferon;
* patients who have previously experienced any anaphylactic reactions; patients with an unclear diagnosis of HOI;
* patients participating in another clinical study or living in the same household as an infant already participating in this study;
* patients born prematurely who have not yet reached his/her term equivalent age; and patients with parent(s) or guardian(s) who cannot be contacted by telephone in case of emergency.