Mohs Micrographic SurgeryPhase 2NCT07384767
Efficacy and Safety of Topical Timolol in Secondary Intention Surgical Wounds Healing
A Phase 2 study testing Timolol 0.5% Ophthalmic Solution in people with Mohs Micrographic Surgery and Excision Margin, run by University of California, Davis at 2 sites in United States.
Trial summary
The purpose of this research study is to evaluate the efficacy and safety of topical timolol 0.5% for secondary intention wound healing following 1) Mohs micrographic surgery, 2) standard surgical excision, OR 3) electrodesiccation and curettage (ED\&C). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Mohs Micrographic Surgery, Excision Margin
- What is being tested?
- Timolol 0.5% Ophthalmic Solution
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 220 participants
- Where
- 2 sitesUnited States
- Study dates
- 1 Oct 2026to 31 Dec 2027
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
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
- Male or female subject of any race 18 years old or older
- Patient opt to heal by secondary intention healing after discussion of reconstructive options following excision
- Patients undergoing Mohs micrographic surgery, standard surgical excision, or electrodesiccation and curettage (ED\&C) whose wounds are managed by secondary intention healing.
- Willing to send photos of ulcer at 3 week intervals with ruler measuring length by width
- Able to give informed consent themselves
Who cannot join
- Cyst excisions (due to concern for inflammation)
- Site shows evidence of infection (defined as a moderate or severe rating of all of the following clinical signs/symptoms: 1) increased warmth, 2) increased pain, 3) erythema, and 4) malodorous exudate at Screening or at Randomization (Visit 1), OR total organism count > 1 x 105 colony forming units (CFU) from the screening visit study ulcer culture sample)
- Severe COPD/asthma/cardiac arrhythmia
- Hx of documented beta blocker allergy
- Cognitive impairment
- Has medically documented history of Human Immunodeficiency Virus (HIV)
Show all 21Show fewer
- Has active malignancy on the study limb
- Has immunodeficiency as defined by serum IgG, IgA, and IgM less than one-half the lower limit of normal
- Has severe protein malnutrition as defined by serum albumin < 2.5 g/dL
- Has serum aspartate aminotransferase (AST, SGOT, GOT) or serum alanine aminotransferase (ALT, SGPT, GPT) levels greater than twice the upper limit of normal
- Has fatigue, palpitations, dyspnea, and/or angina at rest
- Has a medically documented or self-reported history, within the previous 12 months from date of Screening Visit, of alcohol or drug abuse, particularly methadone or heroin
- Has received previous treatment with the following during the 60 days prior to Screening: Immunosuppressive agents, radiation, chemotherapy, growth factors (epidermal growth factor, tumor necrosis factor, transforming growth factor, platelet derived growth factor, etc.)
- Has received previous treatment with the following during the 30 days prior to screening: the site of the study ulcer, split- or full-thickness skin graft at the site of the study ulcer, biologically-active (or engineered) cellular or acellular product(s) at the site of the study ulcer, investigational drug or device
- Has history of bradycardia (heart rate less than 60)
- Has ESR>70mm/hr and CRP>100 mg/L at time of screening
- Has medically documented history of hypotension/orthostatic hypotension and/or symptomatic hypotension (systolic blood pressure below 90 and diastolic blood pressure less than 60). (Note: There is no standard testing regimen protocol for orthostatic hypotension, even for patients starting on oral timolol)
- Currently taking asthma or COPD medications (as documented in chart)
- Has a medically documented diagnosis of myasthenia gravis, untreated hyperthyroidism, , Type 2, Type 3 heart block, cardiogenic shock, overt cardiac failure
- Female who is pregnant or refuses to use adequate contraceptive methods and is of childbearing age during the trial
- Prisoners, institutionalized individuals or vulnerable population
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
United States2 sites
VA Medical Center- Sacramento
Sacramento, California, 95655
Pooja Shet, BS, pooja.shet1@va.gov
Rivkah Isseroff, MD
UC Davis Health- Dermatology
Sacramento, California, 95816
Ted Jacob, MD, tvjacoby@health.ucdavis.edu
Salsala Nasim, BS, 916-551-2636, sanasim@health.ucdavis.edu
About this study
Official title: Efficacy and Safety of Topical Timolol in the Treatment of Cutaneous Surgical Wounds Left to Heal by Secondary Intention
The purpose of this research study is to evaluate the efficacy and safety of topical timolol 0.5% for secondary intention wound healing following 1) Mohs micrographic surgery, 2) standard surgical excision, OR 3) electrodesiccation and curettage (ED\&C). Please note that healing by secondary intention refers to when a wound heals naturally without surgical closure.
To evaluate the efficacy of topical timolol 0.5%, 220 participants will be recruited. Participants will be placed into one of two groups: The treatment group or the control group.
Read more
- The treatment group will receive a topical timolol 0.5% solution, which will be applied to their wound daily for 12 weeks.
- The control group will receive standard care with the addition of hydrogel, which will also be applied to their wound daily for 12 weeks.
During this 12-week period, both groups will be required to upload photos of their wound healing to their MyChart account at weeks 3, 6, 9, and 12. These photos will be reviewed by the investigator to assess wound healing. Re-epithelialization and earlier complete wound healing will be compared between both groups to determine the efficacy of topical timolol 0.5% solution compared to the standard of care.
Read the detailed description
Secondary intention healing after cutaneous excisions or Mohs surgery is a commonly utilized technique in areas that are under high tension, in which primary closure would not be effective, or when patients defer a more complex closure technique. Secondary intention healing has drawbacks, as they take longer to heal and patients are left with a large wound at the surgical site for approximately 8 weeks. Topical timolol has shown promising results in lower extremity ulcers to improve wound healing, however larger trials on secondary intention surgical wounds have not been studied. This trial aims to fill this gap by comparing the efficacy and safety of topical timolol to standard wound care over a 12-week interval.
Participants who agree to the study, and who have opted to heal by secondary intention healing following their 1) Mohs micrographic surgery, 2) standard surgical excision, OR 3) electrodesiccation and curettage (ED\&C) will be consented.
Once consented, the participant's demographics, medical history, and surgery details will be collected before being randomized into one of two groups: the treatment group or the control group.
- The treatment group will receive a topical timolol 0.5% solution, which will be applied to their wound daily for 12 weeks.
- The control group will receive standard care with the addition of hydrogel, which will also be applied to their wound daily for 12 weeks.
The participants and the research team will be blinded, meaning that they will not know which treatment the participant receives. Participants in both groups will be asked to upload photos of their wound healing at weeks 3, 6, 9, and 12 for the research team to examine.
The data will be analyzed to determine which group experienced faster re-epithelialization and earlier complete wound healing.
- Conditions
- Mohs Micrographic Surgery, Excision Margin
- Being tested
- Timolol 0.5% Ophthalmic Solution, Hydrogel of placebo
- Keywords
- standard surgical excision, Mohs micrographic surgery, electrodesiccation and curettage, timolol, randomized
- Medical subject headings
- Margins of Excision
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Timolol 0.5% Ophthalmic SolutionDrug
Topical Timolol 0.5% solution will be applied to patients wounds in 2 cm intervals along the widest diameter of the wound daily for 12 weeks following their medical procedure.
Hydrogel of placeboOther
Hydrogel will be placed on the wound at 2 cm intervals along the widest diameter of the wound daily for 12 weeks following the patient's medical procedure.
| Study group | Role | What they receive |
|---|---|---|
| Timolol | Experimental | The treatment group will receive a topical timolol 0.5% solution, which will be applied to their wound daily for 12 weeks. Receives: Drug: Timolol 0.5% Ophthalmic Solution |
| Hydrogel | Placebo comparator | The control group will receive standard care with the addition of hydrogel, which will also be applied to their wound daily for 12 weeks. Receives: Other: Hydrogel of placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Area of Surgical Ulcer
The percent change in the area of surgical ulcers in patients using the study medication (treatment group) will be compared to those receiving standard care (placebo group).
Measured: Baseline, week 3, week 6, week 9 and week 12
Secondary outcomes (8)
Infection Rate
The number of patients who develop infections during treatment in both the treatment and placebo groups.
Measured: Baseline to Week 12
Risk Factor for Poor Wound Healing
Sub-group analysis in patients with risk factors for poor wound healing; diabetes, smoking, cardiovascular disease, peripheral vascular disease, venous insufficiency, and/or long term prednisone use.
Measured: Baseline to Week 12
Type of Wounds
Subgroup analyses will be performed by wound type (Mohs surgery, excision, ED\&C) to assess for differential treatment effects.
Measured: Baseline to Week 12
Incidences of Hypotension
Incidence of clinically significant hypotension (requiring medical attention) in patients treated with timolol
Measured: Baseline to Week 12
Incidences of COPD or Asthma Exacerbations
Incidence of Chronic Obstructive Pulmonary Disease (COPD) or Asthma exacerbations in patients treated with timolol vs control.
Measured: Baseline to Week 12
Incidences of Hypertrophic Scar or Keloid
The number of patients developing hypertrophic scar or keloid.
Measured: Baseline to Week 12
Incidences of Post Operative Bleeding
The number of patients who developed post operative bleeding, and those who needed intervention by our clinic.
Measured: Baseline to Week 12
Use of Antibiotic
The number of patients who started a topical or oral antibiotic during study treatment.
Measured: Baseline to Week 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Feb 2026
- Study start1 Oct 2026 (estimated)
- Primary completion1 Sep 2027 (estimated)
- Study completion31 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Mohs Micrographic SurgeryStudies of the same condition, open and under way.
- More trials run by University of California, DavisThe 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 220 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of California, Davis
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07384767
- Sponsor's protocol ID
- 24034230
- Status last verified
- Aug 2026
- First submitted
- 26 Jan 2026
- Last updated
- 18 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy and Safety of Topical Timolol in the Treatment of Cutaneous Surgical Wounds Left to Heal by Secondary Intention
- ClinicalTrials.gov ID
- NCT07384767
- Acronym / sponsor ID
- 24034230
- Conditions
- Mohs Micrographic Surgery, Excision Margin
- Keywords
- standard surgical excision, Mohs micrographic surgery, electrodesiccation and curettage, timolol, randomized
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 220 participants (estimated)
- Lead sponsor
- University of California, DavisUniversity, hospital or other
- Study start
- 1 Oct 2026 (estimated)
- Primary completion
- 1 Sep 2027 (estimated)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 3 Feb 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this research study is to evaluate the efficacy and safety of topical timolol 0.5% for secondary intention wound healing following 1) Mohs micrographic surgery, 2) standard surgical excision, OR 3) electrodesiccation and curettage (ED\&C). Please note that healing by secondary intention refers to when a wound heals naturally without surgical closure.
To evaluate the efficacy of topical timolol 0.5%, 220 participants will be recruited. Participants will be placed into one of two groups: The treatment group or the control group.
- The treatment group will receive a topical timolol 0.5% solution, which will be applied to their wound daily for 12 weeks.
- The control group will receive standard care with the addition of hydrogel, which will also be applied to their wound daily for 12 weeks.
During this 12-week period, both groups will be required to upload photos of their wound healing to their MyChart account at weeks 3, 6, 9, and 12. These photos will be reviewed by the investigator to assess wound healing. Re-epithelialization and earlier complete wound healing will be compared between both groups to determine the efficacy of topical timolol 0.5% solution compared to the standard of care.
Detailed description
Secondary intention healing after cutaneous excisions or Mohs surgery is a commonly utilized technique in areas that are under high tension, in which primary closure would not be effective, or when patients defer a more complex closure technique. Secondary intention healing has drawbacks, as they take longer to heal and patients are left with a large wound at the surgical site for approximately 8 weeks. Topical timolol has shown promising results in lower extremity ulcers to improve wound healing, however larger trials on secondary intention surgical wounds have not been studied. This trial aims to fill this gap by comparing the efficacy and safety of topical timolol to standard wound care over a 12-week interval.
Participants who agree to the study, and who have opted to heal by secondary intention healing following their 1) Mohs micrographic surgery, 2) standard surgical excision, OR 3) electrodesiccation and curettage (ED\&C) will be consented.
Once consented, the participant's demographics, medical history, and surgery details will be collected before being randomized into one of two groups: the treatment group or the control group.
- The treatment group will receive a topical timolol 0.5% solution, which will be applied to their wound daily for 12 weeks.
- The control group will receive standard care with the addition of hydrogel, which will also be applied to their wound daily for 12 weeks.
The participants and the research team will be blinded, meaning that they will not know which treatment the participant receives. Participants in both groups will be asked to upload photos of their wound healing at weeks 3, 6, 9, and 12 for the research team to examine.
The data will be analyzed to determine which group experienced faster re-epithelialization and earlier complete wound healing.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Timolol | Experimental | Drug: Timolol 0.5% Ophthalmic SolutionThe treatment group will receive a topical timolol 0.5% solution, which will be applied to their wound daily for 12 weeks. |
| Hydrogel | Placebo comparator | Other: Hydrogel of placeboThe control group will receive standard care with the addition of hydrogel, which will also be applied to their wound daily for 12 weeks. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Male or female subject of any race 18 years old or older
- Patient opt to heal by secondary intention healing after discussion of reconstructive options following excision
- Patients undergoing Mohs micrographic surgery, standard surgical excision, or electrodesiccation and curettage (ED\&C) whose wounds are managed by secondary intention healing.
- Willing to send photos of ulcer at 3 week intervals with ruler measuring length by width
- Able to give informed consent themselves
Key exclusion criteria (21 listed)
- Cyst excisions (due to concern for inflammation)
- Site shows evidence of infection (defined as a moderate or severe rating of all of the following clinical signs/symptoms: 1) increased warmth, 2) increased pain, 3) erythema, and 4) malodorous exudate at Screening or at Randomization (Visit 1), OR total organism count > 1 x 105 colony forming units (CFU) from the screening visit study ulcer culture sample)
- Severe COPD/asthma/cardiac arrhythmia
- Hx of documented beta blocker allergy
- Cognitive impairment
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Timolol 0.5% Ophthalmic SolutionTopical Timolol 0.5% solution will be applied to patients wounds in 2 cm intervals along the widest diameter of the wound daily for 12 weeks following their medical procedure. | Drug | Timolol |
| Hydrogel of placeboHydrogel will be placed on the wound at 2 cm intervals along the widest diameter of the wound daily for 12 weeks following the patient's medical procedure. | Other | Hydrogel |
Primary outcome
Area of Surgical Ulcer
Time frame: Baseline, week 3, week 6, week 9 and week 12
The percent change in the area of surgical ulcers in patients using the study medication (treatment group) will be compared to those receiving standard care (placebo group).
8 secondary outcomes
Infection Rate
Time frame: Baseline to Week 12
Risk Factor for Poor Wound Healing
Time frame: Baseline to Week 12
Type of Wounds
Time frame: Baseline to Week 12
Incidences of Hypotension
Time frame: Baseline to Week 12
Incidences of COPD or Asthma Exacerbations
Time frame: Baseline to Week 12
Incidences of Hypertrophic Scar or Keloid
Time frame: Baseline to Week 12
Incidences of Post Operative Bleeding
Time frame: Baseline to Week 12
Use of Antibiotic
Time frame: Baseline to Week 12
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Aug 2026.
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The Effects of Timolol On Healing and Cosmesis of Mohs Scalp Wounds: An Open Label Trial
Surgical Wounds, Mohs Surgery
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Timolol 0.5% Ophthalmic Solution in people with Mohs Micrographic Surgery and Excision Margin, run by University of California, Davis at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 21 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 18 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Daniel Eisen, MD ((916)-551-2611, dbeisen@health.ucdavis.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Area of Surgical Ulcer (time frame: Baseline, week 3, week 6, week 9 and week 12). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Aug 2026.