Topical Timolol 0.5% Solution for Proliferating Infantile Hemangiomas

Oregon Health & Science University (OHSU)

Status and phase: Terminated; Early Phase 1

Conditions: Infant; Hemangioma

Treatments: Drug: Control (placebo) group; Drug: topical 0.5% Timolol

Study type: Interventional

Funder types: Other

Identifiers

NCT01147601

6114

Details and patient eligibility

About

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.

Full 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.

Enrollment: 6 patients

Sex: All

Ages: 1 to 8 months old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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6 participants in 2 patient groups, including a placebo group

Topical 0.5% Timolol

Active Comparator group

Description:

Half of the enrolled subjects (intervention group) will receive topical 0.5% Timolol.

Treatment:

Drug: topical 0.5% Timolol

Placebo

Placebo Comparator group

Description:

Aqueous placebo, 2-3 drops to cover the hemangioma, twice daily

Treatment:

Drug: Control (placebo) group