Topical Timolol 0.5% Solution for Proliferating Infantile Hemangiomas

The recruitment status of this study is unknown because the information has not been verified recently.
Verified June 2010 by Oregon Health and Science University.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
Oregon Health and Science University
ClinicalTrials.gov Identifier:
NCT01147601
First received: June 14, 2010
Last updated: June 18, 2010
Last verified: June 2010
  Purpose

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.


Condition Intervention Phase
Hemangioma
Infant
Drug: topical 0.5% Timolol
Drug: Control (placebo) group
Phase 0

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Topical Timolol 0.5% Solution for Proliferating Infantile Hemangiomas: A Prospective Double Blinded Placebo Controlled Study

Resource links provided by NLM:


Further study details as provided by Oregon Health and Science University:

Primary Outcome Measures:
  • 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. [ Time Frame: at 6 months ] [ Designated as safety issue: Yes ]
    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%.


Secondary Outcome Measures:
  • Compare treatment group to control group improvement assessments [ Time Frame: at 6 months ] [ Designated as safety issue: Yes ]
    1. 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.
    2. The difference between the extent/size of the hemangioma as an outcome measure versus color changes.
    3. Frequency of adverse events (e.g. hypotension, behavioral changes, etc.), collected by the investigator and reported by the parents.


Estimated Enrollment: 75
Study Start Date: March 2010
Estimated Primary Completion Date: March 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Topical 0.5% Timolol
Half of the enrolled subjects (intervention group) will receive topical 0.5% Timolol.
Drug: topical 0.5% Timolol
topical 0.5% Timolol aqueous solution, 2-3 drops to cover the hemangioma, twice daily
Placebo Comparator: Placebo
Aqueous placebo, 2-3 drops to cover the hemangioma, twice daily
Drug: Control (placebo) group
Control (placebo) group

Detailed 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.

  Eligibility

Ages Eligible for Study:   1 Month to 8 Months
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01147601

Contacts
Contact: Alfons L. Krol, M.D. 503 494 9333 krola@ohsu.edu
Contact: Lindsay K. Severson, B.S., CCRC 503 494 6009 seversol@ohsu.edu

Locations
United States, Oregon
Oregon Health & Science University Recruiting
Portland, Oregon, United States, 97239-4501
Contact: Alfons L. Krol, M.D.    503-494-9993    krola@ohsu.edu   
Contact: Lindsay K. Severson, B.A., CCRC    503 494 6009    seversol@ohsu.edu   
Principal Investigator: Alfons L. Krol, M.D.         
Sponsors and Collaborators
Oregon Health and Science University
Investigators
Principal Investigator: Alfons L. Krol, M.D. Oregon Health and Science University
  More Information

No publications provided

Responsible Party: Alfons L. Krol, M.D., Oregon Health & Science University
ClinicalTrials.gov Identifier: NCT01147601     History of Changes
Other Study ID Numbers: 6114
Study First Received: June 14, 2010
Last Updated: June 18, 2010
Health Authority: United States: Institutional Review Board

Keywords provided by Oregon Health and Science University:
topical 0.5% Timolol
infantile hemangioma (IH)

Additional relevant MeSH terms:
Hemangioma
Hemangioma, Capillary
Neoplasms, Vascular Tissue
Neoplasms by Histologic Type
Neoplasms
Timolol
Pharmaceutical Solutions
Adrenergic beta-Antagonists
Adrenergic Antagonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Physiological Effects of Drugs
Anti-Arrhythmia Agents
Cardiovascular Agents
Therapeutic Uses
Antihypertensive Agents

ClinicalTrials.gov processed this record on August 19, 2014