Spots Global Cancer Trial Database for Topical Timolol Gel for the Treatment of Infantile Hemangiomas

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Trial Identification

Brief Title: Topical Timolol Gel for the Treatment of Infantile Hemangiomas

Official Title: Topical Timolol Gel for the Treatment of Infantile Hemangiomas

Study ID: NCT02145884

Conditions

Hemangioma

Interventions

timolol maleate 0.5% gel

Study Description

Brief 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.

Detailed Description: Subjects will be assigned to open label timolol maleate 0.5%. Parents will be instructed to place 1 to 2 drops twice a day in the center of the hemangioma. Subjects are expected to use the study drug as directed every day for a 4 month period. Subjects will be assessed at baseline, 2 weeks, 4 weeks, and every 4 weeks thereafter for a total of 5 months. Physical exam, photographs to compare size and color intensity, and a scale of improvement will be completed at each visit. Parents will complete a quality of life questionnaire regarding their child's hemangioma and its impact on quality of life. Subjects who have evidence of worsening would be removed from the study and transferred to the clinic for evaluation and treatment.