Topical Timolol Gel for the Treatment of Infantile Hemangiomas

• Status: Completed
• Trial end date: 2016-11-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Rady Children's Hospital, San Diego
• Collaborators: ICN Pharmaceuticals; Valeant Pharmaceuticals
• Treatments: Maleic acid; Timolol

Criteria

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.