Topical 0.5% Timolol Solution for Healing Lower Extremity Wounds

NCT ID: NCT06941467

Last Updated: 2025-04-23

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: PHASE1
• Total Enrollment: 102 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-01-03
• Study Completion Date: 2026-04-01

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Timolol

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

Group Type: EXPERIMENTAL

Timolol Maleate Solution

Intervention Type: 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.

Standard of Care

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

Group Type: ACTIVE_COMPARATOR

Standard of Care

Intervention Type: OTHER

Vaseline

Interventions

Timolol Maleate Solution

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.

Intervention Type: DRUG

Standard of Care

Vaseline

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• 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

Exclusion Criteria

• 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
• Patients who have a wound where primary closure is feasible and desired by the patient
• Defect size <0.5 cm
• Prior sensitivity or known allergy to timolol

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Icahn School of Medicine at Mount Sinai

OTHER

Sponsor Role: lead

Responsible Party

Jesse Lewin

Vice Chair of Surgical Operations, System Chief of the Division of Dermatologic & Cosmetic Surgery

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Jesse Lewin, MD

Role: PRINCIPAL_INVESTIGATOR

Primary Investigator

Locations

Mount Sinai

New York, New York, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Jesse Lewin, MD

Role: CONTACT

jesse.lewin@mountsinai.org

212-731-3316

Jaclyn Himeles, MD

Role: CONTACT

jaclyn.himeles@mountsinai.org

212-731-3316

Facility Contacts

Jesse Lewin, MD

Role: primary

jesse.lewin@mountsinai.org

212-731-3316

Jaclyn Himeles, MD

Role: backup

jaclyn.himeles@Mountsinai.org

212-731-3316

Other Identifiers

STUDY-23-01193

Identifier Type: -

Identifier Source: org_study_id