Timolol for the Prevention of Proliferation of Infantile Hemangioma (TiPPIH Trial)

NCT01434849 | Terminated Phase 1 DMC

• 1 other identifier: HSC20110333H
• Study Type: interventional
• Target: 26
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this trial is to see if a topical beta blocker is effective in preventing the proliferation of infantile hemangioma.

Conditions

Infantile Hemangioma; Very Low Birth Weight Infants

Keywords

infantile hemangioma; very low birth weight infants; premature infants

Outcome Measures

Primary Outcomes (1)

• Proportion of subjects in treatment group compared to placebo group with at least 50% improvement in the extent of hemangioma as compared to each other with respect to changes from baseline photographs.

  hemangioma once detected will be measured and photographed. Measurements and photographs will be obtained every 2 weeks while the patient is in hospital and monthly after discharged until end point of 6 months.

  6 months

Secondary Outcomes (3)

• Compare treatment group to placebo group assessments

  6 months

• Compare treatment group to placebo group assessments

  6 months

• Compare treatment group to placebo group assessments

  6 months

Study Arms (2)

Timolol

EXPERIMENTAL

Application of 1-2 drops of Timolol maleate 0.5% ophthalmic aqueous solution to hemangioma twice daily.

Drug: topical 0.5% Timolol maleate

Placebo

PLACEBO COMPARATOR

Application of 1-2 drops of placebo gel twice daily to hemangioma.

Drug: Control (placebo) group

Interventions

topical 0.5% Timolol maleate DRUG

topical 0.5% Timolol aqueous solution, 1-2 drops to cover the hemangioma, twice daily

Timolol

Control (placebo) group DRUG

Aqueous placebo, 1-2 drops to cover the hemangioma, twice daily

Placebo

Eligibility Criteria

• Age: Up to 6 Months
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Babies admitted to NICU or seen in follow clinic that have a diagnosis of hemangioma that is verified by Principal Investigator (PI) or Co-Principal Investigators.

You may not qualify if:

• Babies with PHACES (Posterior fossa, Hemangioma, Arterial lesions, Cardiac abnormalities, Eye abnormalities) syndrome
• Babies with cardiac conditions that may predispose to heart block
• Babies with persistent hypoglycemia
• Babies on medications that may interact with beta blockers
• Babies who are hemodynamically unstable and are requiring pressors to maintain blood pressure
• Babies who are on systemic corticosteroid therapy

Sponsors & Collaborators

• Alice K. Gong: lead

Study Sites (1)

University of Texas Health Science Center at San Antonio

San Antonio, Texas, 78229-3900, United States

Location

MeSH Terms

Conditions

Hemangioma, Capillary; Premature Birth

Interventions

Timolol; Population Groups

Condition Hierarchy (Ancestors)

Hemangioma; Neoplasms, Vascular Tissue; Neoplasms by Histologic Type; Neoplasms; Obstetric Labor, Premature; Obstetric Labor Complications; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases

Intervention Hierarchy (Ancestors)

Propanolamines; Amino Alcohols; Alcohols; Organic Chemicals; Propanols; Amines; Thiadiazoles; Thiazoles; Sulfur Compounds; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Morpholines; Oxazines; Demography; Population Characteristics

Study Officials

• Alice K Gong, M.D.

  The University of Texas Health Science Center at San Antonio

  PRINCIPAL INVESTIGATOR

• Alice K Gong, MD

  University of Texas

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor of Pediatrics

Study Record Dates

• First Submitted: August 31, 2011
• First Posted: September 15, 2011
• Study Start: July 1, 2012
• Primary Completion: April 1, 2016
• Study Completion: April 1, 2016
• Last Updated: November 15, 2016

Record last verified: 2016-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)