Topical Timolol 0.5% Solution for Proliferating Infantile Hemangiomas

NCT01147601 | Terminated Early Phase 1 Results DMC

• 1 other identifier: 6114
• Study Type: interventional
• Target: 6
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to learn about a new potential use for topical timolol 0.5% aqueous solution that may help treat small uncomplicated infantile hemangiomas. This study would examine whether topical timolol could be a potential therapy.

Conditions

Hemangioma; Infant

Keywords

topical 0.5% Timolol; infantile hemangioma (IH)

Outcome Measures

Primary Outcomes (1)

• Proportion of Subjects in Treatment Group Compared to Placebo Group With at Least 75% Improvement in the Extent of the Hemangioma as Compared to Baseline Photos.

  This will be generated by asking each of the assessors to score the improvement using a visual analog scale (VAS) assessing the decrease in size of hemangioma by comparing photographs at different times of treatment. The assessors will score this improvement into one of the following categories: 0-24%, 25-49%, 50-74%, \>75%.

  at 6 months

Secondary Outcomes (1)

• Compare Treatment Group to Control Group Improvement Assessments

  at 6 months

Study Arms (2)

Topical 0.5% Timolol

ACTIVE COMPARATOR

Half of the enrolled subjects (intervention group) will receive topical 0.5% Timolol.

Drug: topical 0.5% Timolol

Placebo

PLACEBO COMPARATOR

Aqueous placebo, 2-3 drops to cover the hemangioma, twice daily

Drug: Control (placebo) group

Interventions

topical 0.5% Timolol DRUG

topical 0.5% Timolol aqueous solution, 2-3 drops to cover the hemangioma, twice daily

Topical 0.5% Timolol

Control (placebo) group DRUG

Control (placebo) group

Placebo

Eligibility Criteria

• Age: 1 Month - 8 Months
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Infants 1 month to 8 months of age with infantile hemangioma (IH) that are 3 cm or less on the scalp, trunk, or extremities.

You may not qualify if:

• Subjects with facial, genital, perianal, hand, finger, feet, or toe IH
• Subjects with PHACES (plaque-like hemangioma on the face awaiting imaging) syndrome (proven) or suspected PHACES .
• Subjects with IH measuring more than 3cm in size or ulcerated.
• Children with a history of hypersensitivity to beta blockers.
• Children with a personal history of asthma.
• Children with known renal impairment.
• Children with known cardiac conditions that may predispose to heart block
• Personal history of hypoglycemia
• Children on medications that may interact with beta blockers

Sponsors & Collaborators

• Oregon Health and Science University: lead

Study Sites (1)

Oregon Health & Science University

Portland, Oregon, 97239-4501, United States

Location

MeSH Terms

Conditions

Hemangioma; Hemangioma, Capillary

Interventions

Timolol; Population Groups

Condition Hierarchy (Ancestors)

Neoplasms, Vascular Tissue; Neoplasms by Histologic Type; Neoplasms

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

Results Point of Contact

• Title: Dr. Alfons Krol
• Organization: Oregon Health & Science University

krola@ohsu.edu

503-494-9993

Study Officials

• Alfons L. Krol, M.D.

  Oregon Health and Science University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: June 14, 2010
• First Posted: June 22, 2010
• Study Start: March 1, 2010
• Primary Completion: October 1, 2012
• Study Completion: August 1, 2014
• Last Updated: July 5, 2017
• Results First Posted: July 5, 2017

Record last verified: 2017-04

Locations

US (1)