NCT02145884

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
26

participants targeted

Target at below P25 for phase_2

Timeline
Completed

Started May 2014

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2014

Completed
20 days until next milestone

First Submitted

Initial submission to the registry

May 21, 2014

Completed
2 days until next milestone

First Posted

Study publicly available on registry

May 23, 2014

Completed
2.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2016

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2016

Completed
Last Updated

February 13, 2017

Status Verified

February 1, 2017

Enrollment Period

2.4 years

First QC Date

May 21, 2014

Last Update Submit

February 9, 2017

Conditions

Hemangioma

Keywords

hemangiomabirthmarkstrawberry hemangiomatimolol

Outcome Measures

Primary Outcomes (2)

  • 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

  • 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 Outcomes (1)

  • Measure the extent of systemic absorption and the factors which influence absorption

    week 2

Study Arms (1)

timolol maleate 0.5% gel

EXPERIMENTAL

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

Drug: timolol maleate 0.5% gel

Interventions

timolol maleate 0.5% gelDRUG

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

Also known as: timoptic
timolol maleate 0.5% gel

Eligibility Criteria

Age7 Days - 6 Months
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

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

San Diego, California, 92123, United States

Location

MeSH Terms

Conditions

HemangiomaHemangioma, Cavernous

Interventions

TimololGels

Condition Hierarchy (Ancestors)

Neoplasms, Vascular TissueNeoplasms by Histologic TypeNeoplasmsCavernous Sinus SyndromesBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesHemostatic DisordersVascular DiseasesCardiovascular DiseasesHemorrhagic DisordersHematologic DiseasesHemic and Lymphatic Diseases

Intervention Hierarchy (Ancestors)

PropanolaminesAmino AlcoholsAlcoholsOrganic ChemicalsPropanolsAminesThiadiazolesThiazolesSulfur CompoundsAzolesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsMorpholinesOxazinesColloidsComplex MixturesDosage FormsPharmaceutical Preparations

Study Officials

  • Sheila F Friedlander, MD

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

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NA
Masking
NONE
Masking Details
Open label
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD

Study Record Dates

First Submitted

May 21, 2014

First Posted

May 23, 2014

Study Start

May 1, 2014

Primary Completion

October 1, 2016

Study Completion

November 1, 2016

Last Updated

February 13, 2017

Record last verified: 2017-02

Data Sharing

IPD Sharing
Will share

Locations

US(1)