Recruiting
Phase 1

Timolol

Sponsor:

Icahn School of Medicine at Mount Sinai

Code:

NCT06941467

Conditions

Wound Healing

Mohs Micrographic Surgery

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Timolol Maleate Solution

Standard of Care

Study Details

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 ID

NCT06941467

Start date

Jan 3, 2025

Status verified date

Apr, 2025

Completion date

Apr 1, 2026

Anticipated

Primary completion date

Apr 1, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

102 participants

Anticipated

Allocation

Randomized

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: 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.

active comparator: Standard of Care

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

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.

Standard of Care

Vaseline

Primary outcome measure

  • Wound surface area healing (skin reepithelialization) [ Time Frame: 2 weeks, 4 weeks, 6 weeks, 12 weeks ]

Central Contacts and Locations

Central contacts

Jesse Lewin, MD

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

Jaclyn Himeles, MD

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

Locations

Mount Sinai

Recruiting

New York, New York, United States, 10028

Contacts

Jesse Lewin, MD

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

Jaclyn Himeles, MD

212-731-3316jaclyn.himeles@Mountsinai.org

Principal Investigator:

Jesse Lewin, MD

More Information

Sponsor

Icahn School of Medicine at Mount Sinai

Last update posted

Apr 23, 2025

Last verified

Apr, 2025

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Icahn School of Medicine at Mount Sinai on 2025-04-23.