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

7. maj 2026 opdateret af: 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.

Studieoversigt

Status

Ikke rekrutterer endnu

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

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.

Undersøgelsestype

Interventionel

Tilmelding (Anslået)

40

Fase

  • Fase 2

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiekontakt

Undersøgelse Kontakt Backup

Studiesteder

  • Forenede Stater
    • Pennsylvania
      • Danville, Pennsylvania, Forenede Stater, 17821
        • Geisinger Dermatology Woodbine
        • Kontakt:
        • Kontakt:
        • Ledende efterforsker:
          • Amrit Greene, MD

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

  • Voksen
  • Ældre voksen

Tager imod sunde frivillige

Ingen

Beskrivelse

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

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Behandling
  • Tildeling: Randomiseret
  • Interventionel model: Parallel tildeling
  • Maskning: Ingen (Åben etiket)

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Aktiv komparator: Timolol Arm
This arm will have their wounds treated with topical timolol.
Medicin: Topical Timolol
Topical timolol is the active drug that will be compared to placebo in the trial.
Placebo komparator: Standard of Care Arm
This arm will have their wounds treated with normal saline/standard of care.
Medicin: Normal Saline
Normal saline is the placebo that will be compared to topical timolol in the trial.

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Healing At 12 Weeks
Tidsramme: 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
Tidsramme: 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.

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Healing At 8 Weeks
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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.

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Geisinger Clinic

Efterforskere

  • Ledende efterforsker: Amrit Greene, MD, Geisinger Clinic

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Anslået)

1. juli 2026

Primær færdiggørelse (Anslået)

1. juli 2028

Studieafslutning (Anslået)

1. marts 2029

Datoer for studieregistrering

Først indsendt

7. maj 2026

Først indsendt, der opfyldte QC-kriterier

7. maj 2026

Først opslået (Faktiske)

13. maj 2026

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

13. maj 2026

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

7. maj 2026

Sidst verificeret

1. maj 2026

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • Effects of Timolol Mohs Scalp

Plan for individuelle deltagerdata (IPD)

Planlægger du at dele individuelle deltagerdata (IPD)?

INGEN

IPD-planbeskrivelse

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.

Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter

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Ja

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Ingen

produkt fremstillet i og eksporteret fra U.S.A.

Ingen

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