Topical Timolol Gel for the Treatment of Infantile Hemangiomas

Completed · Phase 2

Conditions studied: Hemangioma

In brief

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.

Key facts

Study ID

NCT02145884

Run by

Rady Children's Hospital, San Diego

People needed

26

Starts

2014-05-01

Expected to finish

2016-11-01

Last updated by the study team

2017-02-13

Who can join

Age: 0 and older, up to 1. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• Pediatric and Adolescent Dermatology, Rady Children's Hospital/University of California, San Diego — San Diego, California, United States

Full record on ClinicalTrials.gov

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