search
Back to results

Topical Timolol Gel for the Treatment of Infantile Hemangiomas

Primary Purpose

Hemangioma

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
timolol maleate 0.5% gel
Sponsored by
Rady Children's Hospital, San Diego
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hemangioma focused on measuring hemangioma, birthmark, strawberry hemangioma, timolol

Eligibility Criteria

7 Days - 6 Months (Child)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Written informed permission for study participation and the use of the patient's images are obtained from the patient's parent(s) or guardian(s),

    • The patient is between 7 days and 6 months of age at the time of enrollment,
    • and a proliferating HOI not requiring systemic therapy is present anywhere on the body, Multiple hemangiomas may be treated on same child, if the hemangioma meets this criteria.

Exclusion Criteria:

  • patients who are not otherwise generally healthy;
  • at risk for imminent ulceration, life-threatening, function-threatening, or ulcerated;
  • patients who have previously received systemic, intra-lesional or topical corticosteroids, imiquimod, vincristine, alpha-interferon, propranolol or other beta blockers;
  • patients who have previously been treated for his/her HOI, including any surgical and/or medical procedures;
  • patients whose mothers have been breastfeeding the patient while also being treated with beta-blockers, systemic corticosteroids, vincristine or alpha-interferon;
  • patients who have previously experienced any anaphylactic reactions; patients with an unclear diagnosis of HOI;
  • patients participating in another clinical study or living in the same household as an infant already participating in this study;
  • patients born prematurely who have not yet reached his/her term equivalent age; and patients with parent(s) or guardian(s) who cannot be contacted by telephone in case of emergency.

Sites / Locations

  • Pediatric and Adolescent Dermatology, Rady Children's Hospital/University of California, San Diego

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

timolol maleate 0.5% gel

Arm Description

timolol gel 1 to 2 drops twice a day to lesions for 4 months

Outcomes

Primary Outcome Measures

Change in size of hemangioma
At each visit, the size of the IH is assessed in three dimensions (length, width, and height) in cm.
Change in color of hemangioma
At each visit, the color intensity (e.g., barely perceptible; pale pink or mottled pink/red; red with central pallor; dull red; bright red) of the IH is assessed on a 6 point scale.

Secondary Outcome Measures

Measure the extent of systemic absorption and the factors which influence absorption
A heel stick blood sample is collected to assess for systemic absorption.

Full Information

First Posted
May 21, 2014
Last Updated
February 9, 2017
Sponsor
Rady Children's Hospital, San Diego
Collaborators
Valeant Pharmaceuticals
search

1. Study Identification

Unique Protocol Identification Number
NCT02145884
Brief Title
Topical Timolol Gel for the Treatment of Infantile Hemangiomas
Official Title
Topical Timolol Gel for the Treatment of Infantile Hemangiomas
Study Type
Interventional

2. Study Status

Record Verification Date
February 2017
Overall Recruitment Status
Completed
Study Start Date
May 2014 (Actual)
Primary Completion Date
October 2016 (Actual)
Study Completion Date
November 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Rady Children's Hospital, San Diego
Collaborators
Valeant Pharmaceuticals

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
We plan to conduct a study, to see how safe and effective timolol maleate 0.5% gel-forming solution is for infantile hemangiomas (IH) and the response of hemangiomas to timolol maleate 0.5% . Our hypothesis is that timolol will inhibit and possibly reverse growth of appropriate infantile hemangiomas.
Detailed Description
Subjects will be assigned to open label timolol maleate 0.5%. Parents will be instructed to place 1 to 2 drops twice a day in the center of the hemangioma. Subjects are expected to use the study drug as directed every day for a 4 month period. Subjects will be assessed at baseline, 2 weeks, 4 weeks, and every 4 weeks thereafter for a total of 5 months. Physical exam, photographs to compare size and color intensity, and a scale of improvement will be completed at each visit. Parents will complete a quality of life questionnaire regarding their child's hemangioma and its impact on quality of life. Subjects who have evidence of worsening would be removed from the study and transferred to the clinic for evaluation and treatment.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hemangioma
Keywords
hemangioma, birthmark, strawberry hemangioma, timolol

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Masking Description
Open label
Allocation
N/A
Enrollment
26 (Actual)

8. Arms, Groups, and Interventions

Arm Title
timolol maleate 0.5% gel
Arm Type
Experimental
Arm Description
timolol gel 1 to 2 drops twice a day to lesions for 4 months
Intervention Type
Drug
Intervention Name(s)
timolol maleate 0.5% gel
Other Intervention Name(s)
timoptic
Intervention Description
Apply timolol gel 1-2 drops twice a day to lesion
Primary Outcome Measure Information:
Title
Change in size of hemangioma
Description
At each visit, the size of the IH is assessed in three dimensions (length, width, and height) in cm.
Time Frame
Baseline, week 2, 4, 8, 12, 16
Title
Change in color of hemangioma
Description
At each visit, the color intensity (e.g., barely perceptible; pale pink or mottled pink/red; red with central pallor; dull red; bright red) of the IH is assessed on a 6 point scale.
Time Frame
Baseline, week 2, 4, 8, 12, 16
Secondary Outcome Measure Information:
Title
Measure the extent of systemic absorption and the factors which influence absorption
Description
A heel stick blood sample is collected to assess for systemic absorption.
Time Frame
week 2

10. Eligibility

Sex
All
Minimum Age & Unit of Time
7 Days
Maximum Age & Unit of Time
6 Months
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Written informed permission for study participation and the use of the patient's images are obtained from the patient's parent(s) or guardian(s), The patient is between 7 days and 6 months of age at the time of enrollment, and a proliferating HOI not requiring systemic therapy is present anywhere on the body, Multiple hemangiomas may be treated on same child, if the hemangioma meets this criteria. Exclusion Criteria: patients who are not otherwise generally healthy; at risk for imminent ulceration, life-threatening, function-threatening, or ulcerated; patients who have previously received systemic, intra-lesional or topical corticosteroids, imiquimod, vincristine, alpha-interferon, propranolol or other beta blockers; patients who have previously been treated for his/her HOI, including any surgical and/or medical procedures; patients whose mothers have been breastfeeding the patient while also being treated with beta-blockers, systemic corticosteroids, vincristine or alpha-interferon; patients who have previously experienced any anaphylactic reactions; patients with an unclear diagnosis of HOI; patients participating in another clinical study or living in the same household as an infant already participating in this study; patients born prematurely who have not yet reached his/her term equivalent age; and patients with parent(s) or guardian(s) who cannot be contacted by telephone in case of emergency.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sheila F Friedlander, MD
Organizational Affiliation
Rady Children's Hospital/ University of California, San Diego
Official's Role
Principal Investigator
Facility Information:
Facility Name
Pediatric and Adolescent Dermatology, Rady Children's Hospital/University of California, San Diego
City
San Diego
State/Province
California
ZIP/Postal Code
92123
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
Yes

Learn more about this trial

Topical Timolol Gel for the Treatment of Infantile Hemangiomas

We'll reach out to this number within 24 hrs