Clinical trial NCT06941467: Topical 0.5% Timolol Solution for Healing Lower Extremity Wounds
Official title: Efficacy of Topical 0.5% Timolol Solution for Healing Lower Extremity Wounds
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE1
Conditions: Wound Healing
Mohs Micrographic Surgery
Lead sponsor: Icahn School of Medicine at Mount Sinai
Sponsor class: OTHER
First posted: 2025-04-23
Enrollment: 102
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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

Primary outcomes:
measure: Wound surface area healing (skin reepithelialization)
timeFrame: 2 weeks, 4 weeks, 6 weeks, 12 weeks
Secondary outcomes:
measure: Percentage change in surgical wound size
timeFrame: 2 weeks, 4 weeks, 6 weeks, 12 weeks
measure: Modified Manchester Scar Scale (MMSS)
timeFrame: 2 weeks, 4 weeks, 6 weeks, 12 weeks
measure: The Pain, Enjoyment of Life and General Activity scale (PEG)
timeFrame: 2 weeks, 4 weeks, 6 weeks, 12 weeks
measure: Wound Quality of Life Questionnaire (Wound-QOL)
timeFrame: 2 weeks, 4 weeks, 6 weeks, 12 weeks
Other outcomes:
Locations:
city: New York
country: United States
facility: Mount Sinai
state: New York
Study officials:
affiliation: Primary Investigator
name: Jesse Lewin, MD
role: PRINCIPAL_INVESTIGATOR
References: