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

7. mai 2026 oppdatert av: 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.

Studieoversikt

Status

Har ikke rekruttert ennå

Forhold

Intervensjon / Behandling

Detaljert 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.

Studietype

Intervensjonell

Registrering (Antatt)

40

Fase

  • Fase 2

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiekontakt

Studer Kontakt Backup

Studiesteder

  • Forente stater
    • Pennsylvania
      • Danville, Pennsylvania, Forente stater, 17821
        • Geisinger Dermatology Woodbine
        • Ta kontakt med:
        • Ta kontakt med:
        • Hovedetterforsker:
          • Amrit Greene, MD

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

  • Voksen
  • Eldre voksen

Tar imot friske frivillige

Nei

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

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

  • Primært formål: Behandling
  • Tildeling: Randomisert
  • Intervensjonsmodell: Parallell tildeling
  • Masking: Ingen (Open Label)

Våpen og intervensjoner

Deltakergruppe / Arm
Intervensjon / Behandling
Aktiv komparator: Timolol Arm
This arm will have their wounds treated with topical timolol.
Legemiddel: 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.
Legemiddel: Normal Saline
Normal saline is the placebo that will be compared to topical timolol in the trial.

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
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
Tiltaksbeskrivelse
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.

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Sponsor

Geisinger Clinic

Etterforskere

  • Hovedetterforsker: Amrit Greene, MD, Geisinger Clinic

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart (Antatt)

1. juli 2026

Primær fullføring (Antatt)

1. juli 2028

Studiet fullført (Antatt)

1. mars 2029

Datoer for studieregistrering

Først innsendt

7. mai 2026

Først innsendt som oppfylte QC-kriteriene

7. mai 2026

Først lagt ut (Faktiske)

13. mai 2026

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

13. mai 2026

Siste oppdatering sendt inn som oppfylte QC-kriteriene

7. mai 2026

Sist bekreftet

1. mai 2026

Mer informasjon

Begreper knyttet til denne studien

Nøkkelord

Ytterligere relevante MeSH-vilkår

Andre studie-ID-numre

  • Effects of Timolol Mohs Scalp

Plan for individuelle deltakerdata (IPD)

Planlegger du å dele individuelle deltakerdata (IPD)?

NEI

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.

Legemiddel- og utstyrsinformasjon, studiedokumenter

Studerer et amerikansk FDA-regulert medikamentprodukt

Ja

Studerer et amerikansk FDA-regulert enhetsprodukt

Nei

produkt produsert i og eksportert fra USA

Nei

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