NCT02145884

Topical Timolol Gel for the Treatment of Infantile Hemangiomas

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 26 (actual)
• Sponsor: Rady Children's Hospital, San Diego · Academic / Other
• Sex: All
• Age: 7 Days – 6 Months
• Healthy volunteers: Not accepted

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.

Conditions

• Hemangioma

Interventions

Type	Name	Description
DRUG	timolol maleate 0.5% gel	Apply timolol gel 1-2 drops twice a day to lesion

Timeline

• Start date: 2014-05-01
• Primary completion: 2016-10-01
• Completion: 2016-11-01
• First posted: 2014-05-23
• Last updated: 2017-02-13

Locations

1 site across 1 country: United States