NCT06941467 Topical 0.5% Timolol Solution for Healing Lower Extremity Wounds
| NCT ID | NCT06941467 |
| Status | Recruiting |
| Phase | Phase 1 |
| Sponsor | Icahn School of Medicine at Mount Sinai |
| Condition | Wound Healing |
| Study Type | INTERVENTIONAL |
| Enrollment | 102 participants |
| Start Date | 2025-01-03 |
| Primary Completion | 2026-04-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 1 is the earliest stage of human testing — safety and dosage are the primary focus. Visits are frequent and medical supervision is intensive. You will be among the first people to receive this treatment.
This trial targets 102 participants in total. It began in 2025-01-03 with a primary completion date of 2026-04-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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
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
Contact & Investigator
Jesse Lewin, MD
PRINCIPAL INVESTIGATOR
Primary Investigator
Frequently Asked Questions
Who can join the NCT06941467 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Wound Healing. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT06941467 trial and what does that mean for participants?
Phase 1 trials are the first stage of human testing. The primary goal is to assess safety and determine appropriate dosage levels. Participants are closely monitored. These trials typically involve a small number of volunteers.
Is NCT06941467 currently recruiting?
Yes, NCT06941467 is actively recruiting participants. Contact the research team at jesse.lewin@mountsinai.org for enrollment information.
Where is the NCT06941467 trial being conducted?
This trial is being conducted at New York, United States.
Who is sponsoring the NCT06941467 clinical trial?
NCT06941467 is sponsored by Icahn School of Medicine at Mount Sinai. The principal investigator is Jesse Lewin, MD at Primary Investigator. The trial plans to enroll 102 participants.