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


Phase 0
1 Month
8 Months
Open (Enrolling)
Both
Hemangioma, Infant

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Trial Information

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


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.


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

Type of Study:

Interventional

Study Design:

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

Outcome Measure:

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.

Outcome Description:

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%.

Outcome Time Frame:

at 6 months

Safety Issue:

Yes

Principal Investigator

Alfons L. Krol, M.D.

Investigator Role:

Principal Investigator

Investigator Affiliation:

Oregon Health and Science University

Authority:

United States: Institutional Review Board

Study ID:

6114

NCT ID:

NCT01147601

Start Date:

March 2010

Completion Date:

Related Keywords:

  • Hemangioma
  • Infant
  • topical 0.5% Timolol
  • infantile hemangioma (IH)
  • Hemangioma
  • Hemangioma, Capillary

Name

Location
Oregon Health & Science University Portland, Oregon  97201