NCT06941467 · Icahn School of Medicine at Mount Sinai
Topical 0.5% Timolol Solution for Healing Lower Extremity Wounds
What this study is 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.
View original scientific description
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.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
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
Where
- New York, New York
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Apr 23, 2025 · Source of record for eligibility and locations