Hemangioma Clinical Trial
Official title:
Topical Timolol Gel for the Treatment of Infantile Hemangiomas
Verified date | February 2017 |
Source | Rady Children's Hospital, San Diego |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 26 |
Est. completion date | November 2016 |
Est. primary completion date | October 2016 |
Accepts healthy volunteers | No |
Gender | All |
Age group | N/A to 6 Months |
Eligibility |
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. |
Country | Name | City | State |
---|---|---|---|
United States | Pediatric and Adolescent Dermatology, Rady Children's Hospital/University of California, San Diego | San Diego | California |
Lead Sponsor | Collaborator |
---|---|
Rady Children's Hospital, San Diego | Valeant Pharmaceuticals |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Change in size of hemangioma | At each visit, the size of the IH is assessed in three dimensions (length, width, and height) in cm. | Baseline, week 2, 4, 8, 12, 16 | |
Primary | Change in color of hemangioma | 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. | Baseline, week 2, 4, 8, 12, 16 | |
Secondary | Measure the extent of systemic absorption and the factors which influence absorption | A heel stick blood sample is collected to assess for systemic absorption. | week 2 |
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