- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07583862
The Effects of Timolol On Healing and Cosmesis of Mohs Scalp Wounds: An Open Label Trial
The goal of this study clinical trial is to learn if topical timolol can accelerate healing and improve the cosmetic appearance of surgical wounds on the scalp following Mohs surgery. It will include Geisinger patients 18 year or older who undergo Mohs surgery of the scalp with planned wound healing by secondary intent. The main questions in aim to answer are:
- Compare wound healing speed between patients treated with topical timolol and those receiving standard wound care only.
- Compare cosmetic outcomes using topical timolol and standard wound care.
- Evaluate the impact of topical timolol on the number of unplanned follow-up visits and calls related to delayed wound healing.
Participants will be asked use either topical timolol or use standard wound care to treat their Mohs surgery scalp wound. They will follow-up around 4, 8 and 12 weeks.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Mohs surgical wounds of the scalp and anterior lower leg share several characteristics. They both involve convex surfaces with high tissue tension, and both are often allowed to heal by secondary intent. Secondary intent healing on the scalp is a slow process, with studies noting a mean time for re-epithelialization ranging from 7 to 26 weeks, depending on if the periosteum is intact.
Recently, topical timolol has garnered attention for its effectiveness in promoting healing of open wounds on the lower extremity. Studies have shown improved healing in patients with comorbidities, an impressive safety profile, and improved cosmesis in wounds healing by secondary intent.5 To our knowledge, no study to date has sought to evaluate the effect of topical timolol on surgical wounds of the scalp.
The study population will be patients at our institution who have undergone Mohs surgery and for whom secondary intent healing ("granulation") is deemed an appropriate treatment.
Endpoints will include time to re-epithelialization, percentage change in wound area, and cosmesis (measured using VAS) at pre-determined follow up intervals.
The potential contribution of this research is to provide evidence on the efficacy and safety of topical timolol in accelerating healing and improving the cosmetic appearance of surgical wounds on the scalp.
We anticipate that timolol will speed wound healing and improve cosmesis of scalp wounds, just as it has in other surgical and non-surgical granulating wounds. The benefits of faster healing and improved cosmesis to individual patients are obvious.
This study may also positively impact health care providers and the health care system, as we anticipate those with faster healing wounds will need fewer follow-up visits and make fewer calls for non-healing wounds.
The affordability of topical timolol could make effective wound care more accessible to a broader range of patients, potentially reducing overall healthcare costs associated with prolonged wound healing and complications. In the future, timolol may be used instead of expensive surgical procedures, allografts, xenografts, and other expensive grafting materials. This cost reduction is also anticipated to benefit health systems.
We anticipate that other institutions will adopt the use of topical timolol for Mohs wounds of the scalp, and that eventually this may become the new standard of care.
Study Type
Enrollment (Estimated)
Phase
- Phase 2
Contacts and Locations
Study Contact
- Name: Michael Woodfin, MD
- Phone Number: 570-271-8050
- Email: mwwoodfin1@geisinger.edu
Study Contact Backup
- Name: Amrit Greene, MD
- Phone Number: 570-271-8050
- Email: agreene2@geisinger.edu
Study Locations
-
-
Pennsylvania
-
Danville, Pennsylvania, United States, 17821
- Geisinger Dermatology Woodbine
-
Contact:
- Michael Woodfin, MD
- Phone Number: 570-271-8050
- Email: mwwoodfin1@geisinger.edu
-
Contact:
- Amrit Greene, MD
- Phone Number: 570-271-8050
- Email: agreene2@geisinger.edu
-
Principal Investigator:
- Amrit Greene, MD
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
Age: Adults aged 18 years and older. Condition: Patients who have undergone Mohs surgery on the scalp. Consent: Ability to provide informed consent. Willingness to Participate: Willingness to comply with study procedures and attend follow-up visits.
Healing by Secondary Intention: Wounds intended to heal by secondary intention.
Exclusion Criteria:
- Known allergy or sensitivity to timolol or any components of the study medication.
- Bronchial asthma or history of bronchial asthma
- Severe chronic obstructive pulmonary disease (COPD)
- Sinus bradycardia
- Second or third-degree atrioventricular block
- Overt heart failure
- Cardiogenic shock
- Under the influence of opioids or benzodiazepines at time of enrollment
- History of scarring alopecia in area of Mohs wound
- History of radiation treatment
- Patients being treated for recurrent tumors
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Active Comparator: Timolol Arm
This arm will have their wounds treated with topical timolol.
|
Topical timolol is the active drug that will be compared to placebo in the trial.
|
|
Placebo Comparator: Standard of Care Arm
This arm will have their wounds treated with normal saline/standard of care.
|
Normal saline is the placebo that will be compared to topical timolol in the trial.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Healing At 12 Weeks
Time Frame: From treatment start to follow up 12 weeks later
|
Percentage of patients achieving complete re-epithelialization at 12 weeks
|
From treatment start to follow up 12 weeks later
|
|
Scar Cosmesis
Time Frame: Calculated at 4, 8, and 12 week follow up after treatment start.
|
Scar cosmesis calculated using visual analog scale (VAS)
|
Calculated at 4, 8, and 12 week follow up after treatment start.
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Healing At 8 Weeks
Time Frame: From treatment start to follow up 8 weeks later
|
Percentage of patients achieving complete re-epithelialization at 8 weeks
|
From treatment start to follow up 8 weeks later
|
|
Healing At 4 Weeks
Time Frame: From treatment start to follow up 4 weeks later
|
Percentage of patients achieving complete re-epithelialization at 4 weeks
|
From treatment start to follow up 4 weeks later
|
|
Change In Wound Area at Follow Up
Time Frame: Calculated at 4, 8, and 12 week follow up after treatment start.
|
Percentage change in overall wound area at specified follow up windows.
|
Calculated at 4, 8, and 12 week follow up after treatment start.
|
|
Calls for Non-healing Wounds
Time Frame: From treatment start to 12 weeks.
|
The number of calls made to our clinic for non-healing wounds or other wound related concerns.
|
From treatment start to 12 weeks.
|
|
Visits for Non-healing Wounds
Time Frame: From treatment start to 12 weeks.
|
The number of visits (other than planned follow up) made to our clinic for non-healing wounds or other wound related concerns.
|
From treatment start to 12 weeks.
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Amrit Greene, MD, Geisinger Clinic
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Wounds and Injuries
- Pathologic Processes
- Fibrosis
- Pathological Conditions, Signs and Symptoms
- Surgical Wound
- Cicatrix
- Sulfur Compounds
- Organic Chemicals
- Heterocyclic Compounds, 1-Ring
- Heterocyclic Compounds
- Pharmaceutical Preparations
- Thiazoles
- Azoles
- Amines
- Crystalloid Solutions
- Isotonic Solutions
- Solutions
- Alcohols
- Propanolamines
- Amino Alcohols
- Propanols
- Thiadiazoles
- Morpholines
- Oxazines
- Timolol
- Saline Solution
Other Study ID Numbers
- Effects of Timolol Mohs Scalp
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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