Topical Timolol Gel for the Treatment of Infantile Hemangiomas
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT02145884|
Recruitment Status : Completed
First Posted : May 23, 2014
Last Update Posted : February 13, 2017
|Condition or disease||Intervention/treatment||Phase|
|Hemangioma||Drug: timolol maleate 0.5% gel||Phase 2|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||26 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Masking Description:||Open label|
|Official Title:||Topical Timolol Gel for the Treatment of Infantile Hemangiomas|
|Actual Study Start Date :||May 2014|
|Actual Primary Completion Date :||October 2016|
|Actual Study Completion Date :||November 2016|
Experimental: timolol maleate 0.5% gel
timolol gel 1 to 2 drops twice a day to lesions for 4 months
Drug: timolol maleate 0.5% gel
Apply timolol gel 1-2 drops twice a day to lesion
Other Name: timoptic
- 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.
- 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02145884
|United States, California|
|Pediatric and Adolescent Dermatology, Rady Children's Hospital/University of California, San Diego|
|San Diego, California, United States, 92123|
|Principal Investigator:||Sheila F Friedlander, MD||Rady Children's Hospital/ University of California, San Diego|