Topical Timolol Gel for the Treatment of Infantile Hemangiomas

Hemangioma Clinical Trial

Official title:

Topical Timolol Gel for the Treatment of Infantile Hemangiomas

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02145884
• Other study ID #: PED3560
• Secondary ID: 20132793
• Status: Completed
• Phase: Phase 2
• First received: May 21, 2014
• Last updated: February 9, 2017
• Start date: May 2014
• Est. completion date: November 2016

Study information

• Verified date: February 2017
• Source: Rady Children's Hospital, San Diego
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 26
• Est. completion date: November 2016
• Est. primary completion date: October 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A to 6 Months

Eligibility

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.

Related Conditions & MeSH terms

• Hemangioma
• Hemangioma, Capillary
• Port-Wine Stain

Intervention

Drug:
• timolol maleate 0.5% gel
Apply timolol gel 1-2 drops twice a day to lesion

Locations

Country	Name	City	State
United States	Pediatric and Adolescent Dermatology, Rady Children's Hospital/University of California, San Diego	San Diego	California

Sponsors (2)

Lead Sponsor	Collaborator
Rady Children's Hospital, San Diego	Valeant Pharmaceuticals

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in size of hemangioma	At each visit, the size of the IH is assessed in three dimensions (length, width, and height) in cm.	Baseline, week 2, 4, 8, 12, 16
Primary	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.	Baseline, week 2, 4, 8, 12, 16
Secondary	Measure the extent of systemic absorption and the factors which influence absorption	A heel stick blood sample is collected to assess for systemic absorption.	week 2