DrugLib.com — Drug Information Portal

Rx drug information, pharmaceutical research, clinical trials, news, and more



Topical Timolol Gel for the Treatment of Infantile Hemangiomas

Information source: Rady Children's Hospital, San Diego
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Hemangioma

Intervention: timolol maleate 0.5% gel (Drug); Placebo vehicle/solution (Drug)

Phase: Phase 1/Phase 2

Status: Not yet recruiting

Sponsored by: Rady Children's Hospital, San Diego

Official(s) and/or principal investigator(s):
Sheila F Friedlander, MD, Principal Investigator, Affiliation: Rady Children's Hospital/ University of California, San Diego

Overall contact:
Ann Funk, RN, Phone: 858-576-1700, Ext: 4295, Email: afunk@rchsd.org

Summary

We plan to conduct a study, to see how safe and effective timolol maleate 0. 5% gel is for hemangiomas of infancy (HOI) and the response of hemangiomas to timolol maleate 0. 5% versus a control solution. Our hypothesis is that timolol will inhibit and possibly reverse growth of appropriate infantile hemangiomas as compared to a control solution.

Clinical Details

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

Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment

Primary outcome: Change in size of hemangioma

Secondary outcome: Measure of the change in color of the hemangioma

Detailed description: Subjects will be randomly assigned to one of two groups: half to timolol maleate 0. 5% gel and the other half to the control solution. The study team as well as the parents of the infants will be blinded as to the subjects' treatment. 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 will be transferred to active timolol if there is evidence of significant worsening at 4 weeks follow-up and beyond, as long as the patient is not at risk of imminent ulceration. Patients who are crossed over to the active timolol arm will be removed from study treatment at that time, but remain on study for follow-up.

Eligibility

Minimum age: N/A. Maximum age: 90 Days. Gender(s): Both.

Criteria:

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 14 and 90 days of age at the time of enrollment,

- and a proliferating HOI not requiring systemic therapy is present anywhere on

the body with the largest diameter of at least 1. 5 centimeters, and height not greater than 1. 5 cm. Multiple hemangiomas may be treated on same child, if the hemangioma meets this criteria. Exclusion Criteria:

- patients who are not otherwise generally healthy;

- patients with HOIs that are greater than 1. 5 cm in height,

- 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.

Locations and Contacts

Ann Funk, RN, Phone: 858-576-1700, Ext: 4295, Email: afunk@rchsd.org

Pediatric and Adolescent Dermatology, Rady Children's Hospital/University of California, San Diego, San Diego, California 92123, United States; Not yet recruiting
Ann Funk, RN, Phone: 858-576-1700, Ext: 4295, Email: afunk@rchsd.org
Nicola Borok, RN, Phone: 858-576-1700, Ext: 4295, Email: nborok@rchsd.org
Sheila F Friedlander, MD, Principal Investigator
Additional Information

Starting date: May 2014
Last updated: May 22, 2014

Page last updated: August 23, 2015

-- advertisement -- The American Red Cross
 
Home | About Us | Contact Us | Site usage policy | Privacy policy

All Rights reserved - Copyright DrugLib.com, 2006-2017