Topical Timolol Gel for the Treatment of Infantile Hemangiomas

NCT ID: NCT02145884

Last Updated: 2017-02-13

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 26 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-05-31
• Study Completion Date: 2016-11-30

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.

Conditions

Hemangioma

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

timolol maleate 0.5% gel

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

Group Type: EXPERIMENTAL

timolol maleate 0.5% gel

Intervention Type: DRUG

Apply timolol gel 1-2 drops twice a day to lesion

Interventions

timolol maleate 0.5% gel

Apply timolol gel 1-2 drops twice a day to lesion

Intervention Type: DRUG

Other Intervention Names

timoptic

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.

• Minimum Eligible Age: 7 Days
• Maximum Eligible Age: 6 Months
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Valeant Pharmaceuticals

INDUSTRY

Sponsor Role: collaborator

Rady Children's Hospital, San Diego

OTHER

Sponsor Role: lead

Responsible Party

Sheila Friedlander

MD

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Sheila F Friedlander, MD

Role: PRINCIPAL_INVESTIGATOR

Rady Children's Hospital/ University of California, San Diego

Locations

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

San Diego, California, United States

Countries

United States

Other Identifiers

20132793

Identifier Type: OTHER

Identifier Source: secondary_id

PED3560

Identifier Type: -

Identifier Source: org_study_id