Topical 0.5% Timolol Solution for Healing Lower Extremity Wounds

Mount Sinai Health System

Status and phase: Enrolling; Phase 1

Conditions: Mohs Micrographic Surgery; Wound Healing

Treatments: Drug: Timolol Maleate Solution; Other: Standard of Care

Study type: Interventional

Funder types: Other

Identifiers

NCT06941467

STUDY-23-01193

Details and patient eligibility

About

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

Enrollment: 102 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Single Group Assignment

Masking: Single Blind

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102 participants in 2 patient groups

Timolol

Experimental group

Description:

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

Treatment:

Drug: Timolol Maleate Solution

Standard of Care

Active Comparator group

Description:

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

Treatment:

Other: Standard of Care