NCT01408056

Brief Summary

The purpose of this study is to determine whether Timolol 0.5% Gel Forming Solution is safe and effective in promoting wound healing of infantile ulcerated hemangiomas compared with standard conservative management with topical antibiotic.

Trial Health

30
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Timeline
Completed

Started Feb 2011

Typical duration for phase_2

Geographic Reach
1 country

1 active site

Status
withdrawn

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

February 1, 2011

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

March 10, 2011

Completed
5 months until next milestone

First Posted

Study publicly available on registry

August 3, 2011

Completed
2.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2014

Completed
Last Updated

January 17, 2014

Status Verified

January 1, 2014

Enrollment Period

2.9 years

First QC Date

March 10, 2011

Last Update Submit

January 16, 2014

Conditions

Infantile Hemangiomas

Keywords

HemangiomaInfantile HemangiomaUlcerated HemangiomaTimololBeta blockerVascular anomaly

Outcome Measures

Primary Outcomes (1)

  • Time to Wound Re-epithelization

    At 3 months

Secondary Outcomes (9)

  • Reduction in Ulcer Surface Area and Depth

    At 3 months

  • Investigator's Global Evaluation of Disease

    At 3 months

  • Timolol Serum Level

    Measured at 1 month into therapy

  • Evaluate number of participants with changes in Glucose levels after drug is applied

    Baseline, day 7, day 14

  • Evaluate number of participants with evidence of changes in blood pressure following administration of Timolol 0.5% GFS

    Baseline, day 7, day 14

  • +4 more secondary outcomes

Study Arms (2)

Timolol 0.5% Gel Forming Solution (GFS)

EXPERIMENTAL

Half of enrolled subjects will receive topical Timolol

Drug: Timolol 0.5% Gel Forming Solution (GFS)

Mupirocin 2% ointment

ACTIVE COMPARATOR

Half of enrolled subjects will receive Mupirocin

Drug: Mupirocin 2% Ointment

Interventions

Timolol 0.5% Gel Forming Solution (GFS)DRUG

Dose-based escalation schedule for topical application: 4-8 kg: Day 0-7: 1 drop every other day; Day 7-14: 1 drop daily; Day 14 - Day 60: 1 drop twice per day 8-12 kg: Day 07: 1 drop daily; Day 7-14: 1 drop twice per day; Day 14 - Day 60: 2 drops twice per day

Also known as: Timolol 0.5% topical
Timolol 0.5% Gel Forming Solution (GFS)
Mupirocin 2% OintmentDRUG

Topical application twice per day for 60 days

Also known as: Mupirocin
Mupirocin 2% ointment

Eligibility Criteria

Age1 Month - 8 Months
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • Infants weighing between 4-12kg
  • Infants with corrected gestational age 44 weeks - 8 months of age
  • Infant with an ulcerated hemangioma
  • Informed consent

You may not qualify if:

  • Ulceration larger than 16cm2
  • Ulcerated hemangioma with active bleeding or infection at time of enrollment
  • Disease threatening hemangioma meeting criteria for oral propranolol
  • Previous treatment with topical/oral corticosteroid or propranolol
  • Medical history of congenital heart disease with decreased cardiac output, stroke/cerebral vasculopathy, active reactive airway disease or metabolic disorder
  • History of an allergic reaction to Mupirocin or Timolol
  • Currently taking medication that would interact with beta-blockers

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Children's Hospital of Philadelphia

Philadelphia, Pennsylvania, 19104, United States

Location

Related Publications (5)

  • Pope E, Chakkittakandiyil A. Topical timolol gel for infantile hemangiomas: a pilot study. Arch Dermatol. 2010 May;146(5):564-5. doi: 10.1001/archdermatol.2010.67. No abstract available.

    PMID: 20479314BACKGROUND

  • Sivamani RK, Pullar CE, Manabat-Hidalgo CG, Rocke DM, Carlsen RC, Greenhalgh DG, Isseroff RR. Stress-mediated increases in systemic and local epinephrine impair skin wound healing: potential new indication for beta blockers. PLoS Med. 2009 Jan 13;6(1):e12. doi: 10.1371/journal.pmed.1000012.

    PMID: 19143471BACKGROUND

  • Sans V, de la Roque ED, Berge J, Grenier N, Boralevi F, Mazereeuw-Hautier J, Lipsker D, Dupuis E, Ezzedine K, Vergnes P, Taieb A, Leaute-Labreze C. Propranolol for severe infantile hemangiomas: follow-up report. Pediatrics. 2009 Sep;124(3):e423-31. doi: 10.1542/peds.2008-3458. Epub 2009 Aug 10.

    PMID: 19706583BACKGROUND

  • Khunger N, Pahwa M. Dramatic response to topical timolol lotion of a large hemifacial infantile haemangioma associated with PHACE syndrome. Br J Dermatol. 2011 Apr;164(4):886-8. doi: 10.1111/j.1365-2133.2010.10177.x. No abstract available.

    PMID: 21158749BACKGROUND

  • Chamlin SL, Haggstrom AN, Drolet BA, Baselga E, Frieden IJ, Garzon MC, Horii KA, Lucky AW, Metry DW, Newell B, Nopper AJ, Mancini AJ. Multicenter prospective study of ulcerated hemangiomas. J Pediatr. 2007 Dec;151(6):684-9, 689.e1. doi: 10.1016/j.jpeds.2007.04.055. Epub 2007 Aug 24.

    PMID: 18035154BACKGROUND

MeSH Terms

Conditions

HemangiomaHemangioma, CapillaryVascular Malformations

Interventions

TimololMupirocinOintments

Condition Hierarchy (Ancestors)

Neoplasms, Vascular TissueNeoplasms by Histologic TypeNeoplasmsCardiovascular AbnormalitiesCardiovascular DiseasesCongenital AbnormalitiesCongenital, Hereditary, and Neonatal Diseases and Abnormalities

Intervention Hierarchy (Ancestors)

PropanolaminesAmino AlcoholsAlcoholsOrganic ChemicalsPropanolsAminesThiadiazolesThiazolesSulfur CompoundsAzolesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsMorpholinesOxazinesEpoxy CompoundsEthers, CyclicEthersPyransFatty AcidsLipidsDosage FormsPharmaceutical Preparations

Study Officials

  • Albert C. Yan, MD

    Children's Hospital of Philadelphia, Chair of Pediatric Dermatology

    PRINCIPAL INVESTIGATOR

  • Vikash S. Oza, MD

    Children's Hospital of Philadelphia, Attending Physician

    PRINCIPAL INVESTIGATOR

  • Patrick McMahon, MD

    Children's Hospital of Philadelphia

    PRINCIPAL INVESTIGATOR
0

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Chief, Section of Pediatric Dermatology

Study Record Dates

First Submitted

March 10, 2011

First Posted

August 3, 2011

Study Start

February 1, 2011

Primary Completion

January 1, 2014

Study Completion

January 1, 2014

Last Updated

January 17, 2014

Record last verified: 2014-01

Locations

US(1)