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Fractional CO2 Laser vs Dermabrasion With 5-Fluorouracil for Acquired Leukoderma

20. september 2026 oppdatert av: Walaa Ashraf Sayed, Al-Azhar University

Fractional Co2 Laser vs Dermabrasion 5-Flurouracil Delivery in Acquired Leukoderma: A Comparative Study

This randomized controlled prospective single-blinded comparative clinical study aims to compare the efficacy and safety of fractional carbon dioxide (CO2) laser therapy versus mechanical dermabrasion, both combined with topical 5-fluorouracil, in the treatment of acquired non-vitiligo leukoderma. The study will evaluate repigmentation, clinical improvement, patient satisfaction, and treatment-related adverse effects.

Studieoversikt

Status

Har ikke rekruttert ennå

Forhold

Intervensjon / Behandling

Detaljert beskrivelse

'Non-vitiligo leukoderma represents a heterogeneous group of acquired hypopigmentary disorders that may occur following burns, inflammatory dermatoses, trauma, or other cutaneous insults. Treatment can be challenging because of altered skin architecture, scar formation, and impaired melanocyte function or availability.

This randomized controlled prospective single-blinded comparative clinical study will include 16 patients with acquired non-vitiligo leukoderma recruited from the outpatient clinic of Al-Azhar University Hospital (Assiut). Eligible lesions will be treated using either fractional carbon dioxide (CO2) laser therapy followed by topical 5-fluorouracil or mechanical dermabrasion followed by topical 5-fluorouracil. Random allocation will be performed using a computer-generated random allocation sequence.

Fractional CO2 laser sessions will be performed at 4-6-week intervals, with a total of 3-4 sessions. Mechanical dermabrasion will be performed until pinpoint bleeding appears, followed immediately by topical 5-fluorouracil application, with a total of 3-4 sessions. Similar post-procedure care will be provided.

Treatment outcomes will be assessed using objective and subjective measures, including the Vancouver Scar Scale, Vitiligo Analysis by Computer Assisted Grid (VACAG), assessment of treatment-related adverse effects, physician assessment of clinical improvement using the Mean Improvement Score by Physician (MISP), standardized clinical photography, and patient satisfaction using a 10-point visual analogue scale. Adverse effects such as infection, scarring, Koebner phenomenon, aggravation of depigmentation, pain, burning sensation, erythema, and edema will be documented.

The study will be conducted after approval by the local Ethics Committee of the Faculty of Medicine, Al-Azhar University, Assiut. Written and verbal informed consent will be obtained from participating patients, and privacy of the collected data will be maintained.'

Studietype

Intervensjonell

Registrering (Antatt)

16

Fase

  • Ikke aktuelt

Kontakter og plasseringer

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

Studiekontakt

Studiesteder

  • Egypt
    • Asyut Governorate
      • Asyut, Asyut Governorate, Egypt, 71511
        • Faculty of medicine, Al-Azhar University Assuit

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

18 år til 75 år (Voksen, Eldre voksen)

Tar imot friske frivillige

Nei

Kjønn som er kvalifisert for studier

Alle

Beskrivelse

Inclusion Criteria:

  • Patients receiving topical treatment will be required to undergo a two-week washout period.
  • No sex predilection.
  • Cooperative patients.
  • Patients with non-vitiligo leukoderma, including post-burn leukoderma, post-inflammatory hypopigmentation, and stable hypopigmented scar.

Exclusion Criteria:

  • Vitiligo leukoderma.
  • History of bleeding disorder or current anticoagulant therapy.
  • Pregnancy or lactation.
  • Keloid scarring or hypertrophic scars.
  • Unrealistic expectations.
  • Laser therapy within one month prior to enrollment.
  • Koebnerization.
  • Photosensitivity.
  • Seizure disorders.
  • Active dermatosis or active bacterial, viral, or fungal cutaneous infection within the treatment area.

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: Enkelt

Våpen og intervensjoner

Deltakergruppe / Arm
Intervensjon / Behandling
Eksperimentell: Fractional CO2 Laser + 5-Fluorouracil

Patients will receive fractional carbon dioxide (CO2) laser therapy followed by topical 5-fluorouracil. Laser parameters will be adjusted according to the site and size of the lesions. Treatment sessions will be performed at 4-6-week intervals for a total of 3-4 sessions. Post-procedure care will include topical antibiotic ointment and emollients.
Enhet: Fractional CO2 Laser

Fractional carbon dioxide (CO2) laser therapy followed by topical 5-fluorouracil application. Laser parameters will be adjusted according to lesion size and site.

Legemiddel: 5-Fluorouracil

Topical 5-fluorouracil applied immediately after fractional CO2 laser or dermabrasion according to the assigned study arm.
Aktiv komparator: Dermabrasion + 5-Fluorouracil

Patients will undergo mechanical dermabrasion using manual or motor-driven dermabrasion until the appearance of pinpoint bleeding, followed immediately by topical 5-fluorouracil application. A total of 3-4 sessions will be performed. Similar post-procedure care will be provided. �
Legemiddel: 5-Fluorouracil

Topical 5-fluorouracil applied immediately after fractional CO2 laser or dermabrasion according to the assigned study arm.

Fremgangsmåte: Dermabrasion

Mechanical dermabrasion using manual or motor-driven dermabrasion followed immediately by topical 5-fluorouracil application.

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Degree of Repigmentation
Tidsramme: At baseline and 6 months after treatment

Repigmentation will be assessed by two blinded dermatologists using the Mean Improvement Score by Physician (MISP), based on a 5-grade scale: grade 1, <25% improvement; grade 2, 25-49%; grade 3, 50-74%; grade 4, >75-99%; and grade 5, 100% complete repigmentation.
At baseline and 6 months after treatment

Samarbeidspartnere og etterforskere

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

Sponsor

Al-Azhar University

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)

26. august 2026

Primær fullføring (Antatt)

26. juli 2027

Studiet fullført (Antatt)

26. august 2027

Datoer for studieregistrering

Først innsendt

9. september 2026

Først innsendt som oppfylte QC-kriteriene

20. september 2026

Først lagt ut (Faktiske)

24. september 2026

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

24. september 2026

Siste oppdatering sendt inn som oppfylte QC-kriteriene

20. september 2026

Sist bekreftet

1. september 2026

Mer informasjon

Begreper knyttet til denne studien

Ytterligere relevante MeSH-vilkår

Andre studie-ID-numre

  • MSC/AZ.AST./DVA021/9/245/4/26

Plan for individuelle deltakerdata (IPD)

Planlegger du å dele individuelle deltakerdata (IPD)?

NEI

IPD-planbeskrivelse

Individual participant data will not be shared with other researchers.

Legemiddel- og utstyrsinformasjon, studiedokumenter

Studerer et amerikansk FDA-regulert medikamentprodukt

Nei

Studerer et amerikansk FDA-regulert enhetsprodukt

Nei

produkt produsert i og eksportert fra USA

Nei

Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .

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