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Topical Timolol Gel for the Treatment of Infantile Hemangiomas

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02145884
Recruitment Status : Completed
First Posted : May 23, 2014
Last Update Posted : February 13, 2017
Sponsor:
Collaborator:
Valeant Pharmaceuticals
Information provided by (Responsible Party):
Sheila Friedlander, Rady Children's Hospital, San Diego

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.

Condition or disease Intervention/treatment Phase
Hemangioma Drug: timolol maleate 0.5% gel Phase 2

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 26 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Masking Description: Open label
Primary Purpose: Treatment
Official Title: Topical Timolol Gel for the Treatment of Infantile Hemangiomas
Actual Study Start Date : May 2014
Actual Primary Completion Date : October 2016
Actual Study Completion Date : November 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Birthmarks

Arm Intervention/treatment
Experimental: timolol maleate 0.5% gel
timolol gel 1 to 2 drops twice a day to lesions for 4 months
Drug: timolol maleate 0.5% gel
Apply timolol gel 1-2 drops twice a day to lesion
Other Name: timoptic




Primary Outcome Measures :
  1. Change in size of hemangioma [ Time Frame: Baseline, week 2, 4, 8, 12, 16 ]
    At each visit, the size of the IH is assessed in three dimensions (length, width, and height) in cm.

  2. Change in color of hemangioma [ Time Frame: Baseline, week 2, 4, 8, 12, 16 ]
    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 :
  1. Measure the extent of systemic absorption and the factors which influence absorption [ Time Frame: week 2 ]
    A heel stick blood sample is collected to assess for systemic absorption.



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Ages Eligible for Study:   up to 6 Months   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02145884


Locations
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United States, California
Pediatric and Adolescent Dermatology, Rady Children's Hospital/University of California, San Diego
San Diego, California, United States, 92123
Sponsors and Collaborators
Rady Children's Hospital, San Diego
Valeant Pharmaceuticals
Investigators
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Principal Investigator: Sheila F Friedlander, MD Rady Children's Hospital/ University of California, San Diego
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Responsible Party: Sheila Friedlander, MD, Rady Children's Hospital, San Diego
ClinicalTrials.gov Identifier: NCT02145884    
Other Study ID Numbers: PED3560
20132793 ( Other Identifier: ICN Pharmaceuticals )
First Posted: May 23, 2014    Key Record Dates
Last Update Posted: February 13, 2017
Last Verified: February 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Keywords provided by Sheila Friedlander, Rady Children's Hospital, San Diego:
hemangioma
birthmark
strawberry hemangioma
timolol
Additional relevant MeSH terms:
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Hemangioma
Hemangioma, Capillary
Port-Wine Stain
Neoplasms, Vascular Tissue
Neoplasms by Histologic Type
Neoplasms
Skin Abnormalities
Congenital Abnormalities
Skin Diseases
Timolol
Adrenergic beta-Antagonists
Adrenergic Antagonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Anti-Arrhythmia Agents
Antihypertensive Agents