Clinical Trial: Topical Timolol Gel for the Treatment of Infantile Hemangiomas

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

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

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 Summary:

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.


Sponsor: Rady Children's Hospital, San Diego

Current Primary Outcome:

  • Change in size of hemangioma [ Time Frame: Baseline, week 2, 4, 8, 12, 16 ]
    At each visit, the size of the IH is assessed in three dimensions (length, width, and height) in cm.
  • Change in color of hemangioma [ Time Frame: Baseline, week 2, 4, 8, 12, 16 ]
    At each visit, the color intensity (e.g., barely perceptible; pale pink or mottled pink/red; red with central pallor; dull red; bright red) of the IH is assessed on a 6 point scale.


Original Primary Outcome: Change in size of hemangioma [ Time Frame: Baseline, week 2, 4, 8, 12, 16 ]

Two independent investigators will score the change in size of hemangioma using photography and a visual analog scale .


Current Secondary Outcome: Measure the extent of systemic absorption and the factors which influence absorption [ Time Frame: week 2 ]

A heel stick blood sample is collected to assess for systemic absorption.


Original Secondary Outcome: Measure of the change in color of the hemangioma [ Time Frame: 1, 2,4,8,12,16 weeks ]

A secondary outcome measure will be investigator scoring the change in color of the hemangioma on a scale rating much worse to much better


Information By: Rady Children's Hospital, San Diego

Dates:
Date Received: May 21, 2014
Date Started: May 2014
Date Completion:
Last Updated: February 9, 2017
Last Verified: February 2017