Absorption and Safety of Topical Timolol to Treat Chronic Wounds

NCT04903366 | Completed FDA Drug

• 1 other identifier: 17-10-00798
• Study Type: observational
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

Topical timolol has been used primarily as eye drops to treat glaucoma for many years. Recent clinical experience has broadened its off-label use for a number of skin conditions, including slow-healing wounds. While there have been extensive safety studies performed on timolol administration to treat the eye, to date, no studies have documented absorption of timolol after applied on chronic wounds. Thus, the purpose of this study is to determine the blood levels of timolol in patients after topical administration to a chronic wound, and compare these levels with those of patients after administration of the same drug formulation on the eye for the indication of glaucoma.

Conditions

Glaucoma, Open-Angle; Chronic Wounds

Keywords

Timolol; Catecholamine; Absorption

Outcome Measures

Primary Outcomes (1)

• Mean plasma concentration of timolol in each group

  For both groups, after administration of timolol drops as prescribed, one 6 mL blood was drawn. After centrifugation, the plasma from both groups was frozen at -80°C until assay.

  Blood was drawn 1 hour after drug administration

Secondary Outcomes (2)

• Systemic levels of timolol dose per body weight

  Blood was drawn 1 hour after drug administration

• Systemic levels of timolol by dose and wound type

  Blood was drawn 1 hour after drug administration

Study Arms (2)

Chronic wound

Any chronic wound, for greater than 30 days with minimal improvement

Drug: Timolol Maleate

Glaucoma

Any diagnosis of glaucoma and active prescription of timolol drops

Drug: Timolol Maleate

Interventions

Timolol Maleate DRUG

timolol maleate 0.5% gel-forming solution

Chronic wound; Glaucoma

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Veterans treated at VA Northern California Health Care System from the Dermatology Wound Clinic and the Eye Clinic.

You may qualify if:

• Over 18 years of age
• Using physician-prescribed timolol as directed
• The ability to read, understand, and sign informed consent for blood draw and release of medical information forms
• For wound group: documented chronic wound (greater than 30 days, with minimal improvement), with any type of wound.
• For glaucoma group: diagnosed with ocular hypertension or open-angle glaucoma.

You may not qualify if:

• Patient is not currently prescribed timolol or currently taking oral metoprolol
• History of any type of heart block
• History of bradycardia (heart-rate less than 60 beats per minute (bpm))
• History of documented hypotension
• History of asthma or chronic obstructive pulmonary disease.

Sponsors & Collaborators

• VA Northern California Health Care System: lead

Study Sites (1)

VA Northern California Health Care System

Mather, California, 95655, United States

Location

Related Publications (1)

• Gallegos AC, Davis MJ, Tchanque-Fossuo CN, West K, Eisentrout-Melton A, Peavy TR, Dixon RW, Patel RP, Dahle SE, Isseroff RR. Absorption and Safety of Topically Applied Timolol for Treatment of Chronic Cutaneous Wounds. Adv Wound Care (New Rochelle). 2019 Nov 1;8(11):538-545. doi: 10.1089/wound.2019.0970. Epub 2019 Oct 16.

  PMID: 31637100 BACKGROUND

MeSH Terms

Conditions

Glaucoma, Open-Angle

Interventions

Timolol

Condition Hierarchy (Ancestors)

Glaucoma; Ocular Hypertension; Eye 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

Study Officials

• Rivkah R Isseroff, MD

  VA Northern California Health Care System

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: FED
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor, Chief of Dermatology

Study Record Dates

• First Submitted: May 21, 2021
• First Posted: May 26, 2021
• Study Start: November 21, 2017
• Primary Completion: March 9, 2018
• Study Completion: January 14, 2020
• Last Updated: May 27, 2021

Record last verified: 2021-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)