The following info and data is provided "as is" to help patients around the globe.
We do not endorse or review these studies in any way.
Brief Title: Timolol Option for Ulcerated Hemangiomas (TOUCH Trial)
Official Title: The Efficacy of Timolol 0.5% Gel Forming Solution for the Treatment of Ulcerated Hemangiomas
Study ID: NCT01408056
Brief Summary: The purpose of this study is to determine whether Timolol 0.5% Gel Forming Solution is safe and effective in promoting wound healing of infantile ulcerated hemangiomas compared with standard conservative management with topical antibiotic.
Detailed Description: Ulceration is the most common complication associated with infantile hemangiomas. Ulceration and the delay in wound healing places patients at risk for infection, bleeding, pain and permanent scarring. Currently, the care of ulcerated hemangiomas is extremely difficult and patients are often subject to multiple treatment modalities. In the past two years, the leading advance in the treatment of hemangiomas has been the use of the non-selective, oral beta-blocker propranolol to arrest growth and promote involution of hemangiomas. Recent literature also suggests beta-blockers may have a role in helping ulcerated wounds re-epithelialize. The use of a topical non-selective beta-blocker on isolated ulcerated hemangiomas may promote early healing and reduce the number of complications associated with ulceration. Investigation is needed to explore the safety and tolerability of applying a topical beta-blocker on an ulcerated hemangioma and whether topical beta-blockade may be more efficacious than conservative care with topical antibiotics. In this study, infants will be randomized to either receive a topical antibiotic (topical mupirocin 2% ointment twice per day) or a topical beta-blocker (Timolol 0.5% Gel Forming Solution) according to a dose-escalation schedule. Subjects will be seen in clinic on day 7, day 14, 1 month and 2 months into therapy and 1 month after therapy is completed. Photographs and safety and efficacy measurements will be taken at each visit to assess response to therapy.
Minimum Age: 1 Month
Eligible Ages: CHILD
Sex: ALL
Healthy Volunteers: No
Children's Hospital of Philadelphia, Philadelphia, Pennsylvania, United States
Name: Albert C. Yan, MD
Affiliation: Children's Hospital of Philadelphia, Chair of Pediatric Dermatology
Role: PRINCIPAL_INVESTIGATOR
Name: Vikash S. Oza, MD
Affiliation: Children's Hospital of Philadelphia, Attending Physician
Role: PRINCIPAL_INVESTIGATOR
Name: Patrick McMahon, MD
Affiliation: Children's Hospital of Philadelphia
Role: PRINCIPAL_INVESTIGATOR