NCT07384767

Brief 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). 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.

  1. 1.The treatment group will receive a topical timolol 0.5% solution, which will be applied to their wound daily for 12 weeks.
  2. 2.The control group will receive standard care with the addition of hydrogel, which will also be applied to their wound daily for 12 weeks.

Trial Health

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Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
220

participants targeted

Target at P75+ for phase_2

Timeline
19mo left

Started Jun 2026

Geographic Reach
1 country

2 active sites

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 26, 2026

Completed
8 days until next milestone

First Posted

Study publicly available on registry

February 3, 2026

Completed
4 months until next milestone

Study Start

First participant enrolled

June 1, 2026

Expected
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2027

4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2027

Last Updated

February 9, 2026

Status Verified

February 1, 2026

Enrollment Period

1.3 years

First QC Date

January 26, 2026

Last Update Submit

February 4, 2026

Conditions

Excision MarginMohs Micrographic Surgery

Keywords

standard surgical excisionMohs micrographic surgeryelectrodesiccation and curettagetimololrandomized

Outcome Measures

Primary Outcomes (1)

  • 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).

    Baseline, week 3, week 6, week 9 and week 12

Secondary Outcomes (8)

  • Infection Rate

    Baseline to Week 12

  • Risk Factor for Poor Wound Healing

    Baseline to Week 12

  • Type of Wounds

    Baseline to Week 12

  • Incidences of Hypotension

    Baseline to Week 12

  • Incidences of COPD or Asthma Exacerbations

    Baseline to Week 12

  • +3 more secondary outcomes

Study Arms (2)

Timolol

EXPERIMENTAL

The treatment group will receive a topical timolol 0.5% solution, which will be applied to their wound daily for 12 weeks.

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.

Other: Hydrogel of placebo

Interventions

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.

Timolol
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.

Hydrogel

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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)
  • 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)
  • +6 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

VA Medical Center- Sacramento

Sacramento, California, 95655, United States

Location

UC Davis Health- Dermatology

Sacramento, California, 95816, United States

Location

MeSH Terms

Conditions

Margins of Excision

Interventions

TimololOphthalmic Solutions

Condition Hierarchy (Ancestors)

Morphological and Microscopic FindingsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

PropanolaminesAmino AlcoholsAlcoholsOrganic ChemicalsPropanolsAminesThiadiazolesThiazolesSulfur CompoundsAzolesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsMorpholinesOxazinesPharmaceutical SolutionsSolutionsPharmaceutical PreparationsTherapeutic UsesPharmacologic ActionsChemical Actions and UsesSpecialty Uses of Chemicals

Central Study Contacts

Daniel Eisen, MD

CONTACT

(916)-551-2611dbeisen@health.ucdavis.edu

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 26, 2026

First Posted

February 3, 2026

Study Start (Estimated)

June 1, 2026

Primary Completion (Estimated)

September 1, 2027

Study Completion (Estimated)

December 31, 2027

Last Updated

February 9, 2026

Record last verified: 2026-02

Locations

US(2)