Topical Timolol 0.5% Solution for Proliferating Infantile Hemangiomas

Infant Clinical Trial

Official title:

Topical Timolol 0.5% Solution for Proliferating Infantile Hemangiomas: A Prospective Double Blinded Placebo Controlled Study

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01147601
• Other study ID #: 6114
• Status: Recruiting
• Phase: Phase 0
• First received: June 14, 2010
• Last updated: June 18, 2010
• Start date: March 2010

Study information

• Verified date: June 2010
• Source: Oregon Health and Science University
• Contact: Alfons L. Krol, M.D.
• Phone: 503 494 9333
• Email: krola[@]ohsu.edu
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to learn about a new potential use for topical timolol 0.5% aqueous solution that may help treat small uncomplicated infantile hemangiomas. This study would examine whether topical timolol could be a potential therapy.

Description:

At the first visit, subjects will fill out a questionnaire that asks about the child's history and the hemangioma. Photographs and measurements will be taken at this and each subsequent visit. At the first visit, subjects will have a physical exam, including vital signs, height and weight. An EKG will also be done. Study drug will be dispensed and instructions given. Half of the subjects will receive a placebo. This is a blinded randomized study. Follow-up visits will be weekly for the first two weeks (three visits total including the first visit), then monthly until the study is over. Photographs and measurements will again be taken at each visit. Subjects will be asked to evaluate the size and the color of the hemangioma against the first photographs and fill out forms regarding any changes in behavior and asked about any side effects.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 75
• Est. primary completion date: March 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 1 Month to 8 Months

Eligibility

Inclusion Criteria:

Infants 1 month to 8 months of age with infantile hemangioma (IH) that are 3 cm or less on the scalp, trunk, or extremities.

Exclusion Criteria:

1. Subjects with facial, genital, perianal, hand, finger, feet, or toe IH

2. Subjects with PHACES syndrome (proven) or suspected PHACES (plaque-like hemangioma on the face awaiting imaging).

3. Subjects with IH measuring more than 3cm in size or ulcerated.

4. Children with a history of hypersensitivity to beta blockers.

5. Children with a personal history of asthma.

6. Children with known renal impairment.

7. Children with known cardiac conditions that may predispose to heart block

8. Personal history of hypoglycemia

9. Children on medications that may interact with beta blockers

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Hemangioma
• Hemangioma, Capillary
• Infant
• Port-Wine Stain

Intervention

Drug:
• topical 0.5% Timolol
topical 0.5% Timolol aqueous solution, 2-3 drops to cover the hemangioma, twice daily
• Control (placebo) group
Control (placebo) group

Locations

Country	Name	City	State
United States	Oregon Health & Science University	Portland	Oregon

Sponsors (1)

Lead Sponsor	Collaborator
Oregon Health and Science University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Proportion of subjects in treatment group compared to placebo group with at least 75% improvement in the extent of the hemangioma as compared to baseline photos.	This will be generated by asking each of the assessors to score the improvement using a visual analog scale (VAS) assessing the decrease in size of hemangioma by comparing photographs at different times of treatment. The assessors will score this improvement into one of the following categories: 0-24%, 25-49%, 50-74%, >75%.	at 6 months	Yes
Secondary	Compare treatment group to control group improvement assessments	The proportion of subjects in the treatment group as compared to the placebo control group with at least 50% improvement in the extent of the hemangioma.; The difference between the extent/size of the hemangioma as an outcome measure versus color changes.; Frequency of adverse events (e.g. hypotension, behavioral changes, etc.), collected by the investigator and reported by the parents.	at 6 months	Yes