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The Effects of Timolol On Healing and Cosmesis of Mohs Scalp Wounds: An Open Label Trial

7 mei 2026 bijgewerkt door: Ami Greene, Geisinger Clinic

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:

  1. Compare wound healing speed between patients treated with topical timolol and those receiving standard wound care only.
  2. Compare cosmetic outcomes using topical timolol and standard wound care.
  3. 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.

Studie Overzicht

Toestand

Nog niet aan het werven

Conditie

Interventie / Behandeling

Gedetailleerde beschrijving

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.

Studietype

Ingrijpend

Inschrijving (Geschat)

40

Fase

  • Fase 2

Contacten en locaties

In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.

Studiecontact

Studie Contact Back-up

Studie Locaties

  • Verenigde Staten
    • Pennsylvania
      • Danville, Pennsylvania, Verenigde Staten, 17821
        • Geisinger Dermatology Woodbine
        • Contact:
        • Contact:
        • Hoofdonderzoeker:
          • Amrit Greene, MD

Deelname Criteria

Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.

Geschiktheidscriteria

Leeftijden die in aanmerking komen voor studie

  • Volwassen
  • Oudere volwassene

Accepteert gezonde vrijwilligers

Nee

Beschrijving

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

Studie plan

Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.

Hoe is de studie opgezet?

Ontwerpdetails

  • Primair doel: Behandeling
  • Toewijzing: Gerandomiseerd
  • Interventioneel model: Parallelle opdracht
  • Masker: Geen (open label)

Wapens en interventies

Deelnemersgroep / Arm
Interventie / Behandeling
Actieve vergelijker: Timolol Arm
This arm will have their wounds treated with topical timolol.
Geneesmiddel: Topical Timolol
Topical timolol is the active drug that will be compared to placebo in the trial.
Placebo-vergelijker: Standard of Care Arm
This arm will have their wounds treated with normal saline/standard of care.
Geneesmiddel: Normal Saline
Normal saline is the placebo that will be compared to topical timolol in the trial.

Wat meet het onderzoek?

Primaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Healing At 12 Weeks
Tijdsspanne: 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
Tijdsspanne: 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.

Secundaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Healing At 8 Weeks
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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.

Medewerkers en onderzoekers

Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.

Sponsor

Geisinger Clinic

Onderzoekers

  • Hoofdonderzoeker: Amrit Greene, MD, Geisinger Clinic

Studie record data

Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.

Bestudeer belangrijke data

Studie start (Geschat)

1 juli 2026

Primaire voltooiing (Geschat)

1 juli 2028

Studie voltooiing (Geschat)

1 maart 2029

Studieregistratiedata

Eerst ingediend

7 mei 2026

Eerst ingediend dat voldeed aan de QC-criteria

7 mei 2026

Eerst geplaatst (Werkelijk)

13 mei 2026

Updates van studierecords

Laatste update geplaatst (Werkelijk)

13 mei 2026

Laatste update ingediend die voldeed aan QC-criteria

7 mei 2026

Laatst geverifieerd

1 mei 2026

Meer informatie

Termen gerelateerd aan deze studie

Trefwoorden

Aanvullende relevante MeSH-voorwaarden

Andere studie-ID-nummers

  • Effects of Timolol Mohs Scalp

Plan Individuele Deelnemersgegevens (IPD)

Bent u van plan om gegevens van individuele deelnemers (IPD) te delen?

NEE

Beschrijving IPD-plan

Although we feel that re-identification of anonymized participants using IPD would be very low risk, we prefer to not add any additional risk of patient identification. Furthermore, funding for this study is limited, and preparing data for sharing, including anonymizing it and creating documentation may not be possible due to budget and time constraints.

Informatie over medicijnen en apparaten, studiedocumenten

Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel

Ja

Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct

Nee

product vervaardigd in en geëxporteerd uit de V.S.

Nee

Deze informatie is zonder wijzigingen rechtstreeks van de website clinicaltrials.gov gehaald. Als u verzoeken heeft om uw onderzoeksgegevens te wijzigen, te verwijderen of bij te werken, neem dan contact op met register@clinicaltrials.gov. Zodra er een wijziging wordt doorgevoerd op clinicaltrials.gov, wordt deze ook automatisch bijgewerkt op onze website .

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