Topical 0.5% Timolol Solution for Healing Lower Extremity Wounds

NCT06941467 | Recruiting Phase 1 DMC FDA Drug

• 1 other identifier: STUDY-23-01193
• Study Type: interventional
• Target: 102
• Locations: 1 country
• Sites: 1

Brief Summary

Topical timolol, a β2-Adrenergic receptor (B2AR) antagonist, has demonstrated promise in wound healing over the past several years. The majority of the literature has evaluated the use of topical timolol to shorten wound healing time in chronic wounds of non-surgical etiologies. To date, there are no prospective randomized clinical trials evaluating the role of topical timolol for shortening wound healing time in acute open surgical wounds. Therefore, the purpose of this study is to determine whether or not topical timolol solution decreases time to wound healing in patients with defects after Mohs Micrographic Surgery (MMS) that cannot be closed with sutures and are left to heal by second intent. The research team also will look to determine if there is a difference in cosmesis of wounds treated with topical timolol compared to those treated with the standard of care. The present study will primarily focus on wounds in the distal lower extremity as these are most commonly left to heal by secondary intent

Conditions

Wound Healing; Mohs Micrographic Surgery

Outcome Measures

Primary Outcomes (1)

• Wound surface area healing (skin reepithelialization)

  The wound surface area healing (skin reepithelialization) in open post-surgical lower extremity wounds will be measured using a ruler.

  2 weeks, 4 weeks, 6 weeks, 12 weeks

Secondary Outcomes (4)

• Percentage change in surgical wound size

  2 weeks, 4 weeks, 6 weeks, 12 weeks

• Modified Manchester Scar Scale (MMSS)

  2 weeks, 4 weeks, 6 weeks, 12 weeks

• The Pain, Enjoyment of Life and General Activity scale (PEG)

  2 weeks, 4 weeks, 6 weeks, 12 weeks

• Wound Quality of Life Questionnaire (Wound-QOL)

  2 weeks, 4 weeks, 6 weeks, 12 weeks

Study Arms (2)

Timolol

EXPERIMENTAL

Participants in the topical timolol group will be instructed to apply 1-3 drops of topical 0.5% timolol solution daily to the wound.

Drug: Timolol Maleate Solution

Standard of Care

ACTIVE COMPARATOR

Standard of Care - Apply Vaseline and Band-Aid to wound bed daily

Other: Standard of Care

Interventions

Timolol Maleate Solution DRUG

Timolol 0.5% solution. The number of drops delivered will be based on the initial wound size and will remain constant for the duration of the study period or until the wound is fully re-epithelialized which will be determined by the PI either by photo or in person visit.

Timolol

Standard of Care OTHER

Vaseline

Standard of Care

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Be scheduled to undergo MMS at 234 East 85th St for a skin cancer that is deemed Mohs
• Appropriate by the Mohs surgery appropriate use criteria
• Have an open surgical wound \< 4 cm and \> 0.5 cm
• Be ≥18 years of age
• English-speaking
• Provide a signed and dated informed consent form
• State willingness to comply with all study procedures

You may not qualify if:

• Age less than 18 years of age
• Open surgical wound \> 4 cm
• If tumor clearance cannot be achieved with MMS
• Pregnant women
• Breastfeeding women
• Patients who are taking oral beta-blockers (ie oral timolol, metoprolol, carvedilol, propranolol, atenolol)
• Patients who are currently taking any of the following medications: clonidine, digoxin, methyldopa, quinidine, fluoxetine and paroxetine, bupropion
• Patient currently taking a calcium channel blocker AND has pre-existing heart failure as defined by a reduced ejection fraction
• Patients with pre-existing hypotension
• Pre-existing diagnosis of sinus bradycardia
• Pre-existing diagnosis of second or third degree atrioventricular block
• Congestive heart failure
• Pre-existing diagnosis of severe asthma
• Pre-existing diagnosis of chronic obstructive pulmonary disease
• Any known hypersensitivity to 0.5% timolol solution

Sponsors & Collaborators

• Icahn School of Medicine at Mount Sinai: lead

Study Sites (1)

Mount Sinai

New York, New York, 10028, United States

RECRUITING

MeSH Terms

Interventions

Standard of Care

Intervention Hierarchy (Ancestors)

Quality Indicators, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation

Study Officials

• Jesse Lewin, MD

  Primary Investigator

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jesse Lewin, MD

CONTACT

212-731-3316; jesse.lewin@mountsinai.org

Jaclyn Himeles, MD

CONTACT

212-731-3316; jaclyn.himeles@mountsinai.org

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Vice Chair of Surgical Operations, System Chief of the Division of Dermatologic & Cosmetic Surgery

Study Record Dates

• First Submitted: April 16, 2025
• First Posted: April 23, 2025
• Study Start: January 3, 2025
• Primary Completion: April 1, 2026
• Study Completion: April 1, 2026
• Last Updated: April 23, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
• Time Frame: Beginning 3 months and ending 5 years following article publication.
• Access Criteria: Investigators whose proposed use of the data has been approved by an independent review committee ('learned intermediary') identified for this purpose. To achieve aims in the approved proposal. Proposals may be submitted up to 36 months following article publication. After 36 months the data will be available in ISMMS data warehouse but without investigator support other than deposited metadata. Information regarding submitting proposals and accessing data may be found at (to be determined).

Locations

US (1)