Wound HealingPhase 1NCT06941467
Topical 0.5% Timolol Solution for Healing Lower Extremity Wounds
A Phase 1 study testing Timolol Maleate Solution in people with Wound Healing and Mohs Micrographic Surgery, run by Icahn School of Medicine at Mount Sinai at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Wound Healing, Mohs Micrographic Surgery
- What is being tested?
- Timolol Maleate Solution
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 102 participants
- Where
- 1 siteUnited States
- Study dates
- 3 Jan 2025to 1 Mar 2027
- Phase
- Phase 1
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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)
Show all 18Show fewer
- 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 locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Mount Sinai
New York, New York, 10028
Jesse Lewin, MD, 212-731-3316, jesse.lewin@mountsinai.org
Jaclyn Himeles, MD, 212-731-3316, jaclyn.himeles@Mountsinai.org
About this study
Official title: Efficacy of Topical 0.5% Timolol Solution for Healing Lower Extremity Wounds
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
- Being tested
- Timolol Maleate Solution, Standard of Care
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Timolol Maleate SolutionDrug
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 CareOther
Vaseline
| Study group | Role | What they receive |
|---|---|---|
| Timolol | Experimental | Participants in the topical timolol group will be instructed to apply 1-3 drops of topical 0.5% timolol solution daily to the wound. Receives: Drug: Timolol Maleate Solution |
| Standard of Care | Active comparator | Standard of Care - Apply Vaseline and Band-Aid to wound bed daily Receives: Other: Standard of Care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Wound surface area healing (skin reepithelialization)
The wound surface area healing (skin reepithelialization) in open post-surgical lower extremity wounds will be measured using a ruler.
Measured: 2 weeks, 4 weeks, 6 weeks, 12 weeks
Secondary outcomes (4)
Percentage change in surgical wound size
Percentage change in surgical wound size
Measured: 2 weeks, 4 weeks, 6 weeks, 12 weeks
Modified Manchester Scar Scale (MMSS)
The Modified Manchester Scar Scale (MMSS) is a clinical tool used to evaluate the appearance and characteristics of scars. The MMSS assess four key aspects of the scar:
- Color (compared to surrounding skin): Rated 1-4
- Perfect match (1) to gross mismatch (4)
- Matte vs. Shine: Rated 1-2
- Matte appearance (1)
- Shiny appearance (2)
- Contour: Rated 1-3
- Flush with surrounding skin (1)
- Slightly proud/indented (2)
- Hypertrophic (3)
- Distortion: Rated 1-4
- No distortion (1 point) to severe distortion (4 points)
The total score ranges from 4 to 13, with higher scores indicating a more noticeable or problematic scar.
Measured: 2 weeks, 4 weeks, 6 weeks, 12 weeks
The Pain, Enjoyment of Life and General Activity scale (PEG)
The PEG, a Three-item Scale Assessing Pain Intensity and Interference Pain is is a 3-item questionnaire that measures pain intensity and pain-related functional interference with open wounds on the lower leg. The assessment includes three domains: average pain intensity (0-10), pain interference with enjoyment of life (0-10), and pain interference with general activity (0-10). The total score ranges from 0-30, with higher scores indicating greater pain intensity and greater pain-related functional interference.
Measured: 2 weeks, 4 weeks, 6 weeks, 12 weeks
Wound Quality of Life Questionnaire (Wound-QOL)
The Wound-QoL is a17-item questionnaire assesses how patients feel about their open wound its impact on their quality of life. The assessment evaluates multiple dimensions of wound-related quality of life, including physical symptoms (items 1-3), functional limitations (items 4, 11-15), psychological well-being (items 6-10), and burden of care (items 5, 16-17). Each item is scored on a 5-point scale from "Not at all" (0) to "Very much" (4). The total score ranges from 0-68, with higher scores indicating lower wound quality of life.
Measured: 2 weeks, 4 weeks, 6 weeks, 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Apr 2025
- Study start3 Jan 2025
- Primary completion31 Jan 2027 (estimated)
- Study completion1 Mar 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Wound HealingStudies of the same condition, open and under way.
- More trials run by Icahn School of Medicine at Mount SinaiThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 102 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Icahn School of Medicine at Mount Sinai
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jesse Lewin, Icahn School of Medicine at Mount Sinai
- Investigators
- Jesse Lewin, MD, Principal investigator, Primary Investigator
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06941467
- Sponsor's protocol ID
- STUDY-23-01193
- Status last verified
- Oct 2026
- First submitted
- 16 Apr 2025
- Last updated
- 9 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: All of the individual participant data collected during the trial, after deidentification.