Deze pagina is automatisch vertaald en de nauwkeurigheid van de vertaling kan niet worden gegarandeerd. Raadpleeg de Engelse versie voor een brontekst.

Vitamin D3 Versus Methotrexate Versus Saline Injections for Plantar Warts

8 november 2026 bijgewerkt door: Noura Abdelmoneim Mohammed Elseessy, Kafrelsheikh University

Clinical and Dermoscopic Evaluation of Efficacy and Safety of Intralesional Injection of Vitamin D3 Versus Intralesional Injection of Methotrexate in Plantar Warts

This clinical trial will compare vitamin D3 injections, methotrexate injections, and saline injections for plantar warts. Plantar warts are warts on the soles of the feet. The study will include 60 adults aged 18 to 50 years at Kafrelsheikh University Hospital, Egypt.

The main questions are:

  • How well does each treatment clear plantar warts?
  • What side effects occur with each treatment?
  • Do the warts return after treatment?

Participants will be assigned by chance to one of three groups, with 20 participants in each group:

  • Vitamin D3 injections into the warts.
  • Methotrexate injections into the warts.
  • Saline injections into the warts. Saline is a saltwater solution used as a placebo comparison.

Participants will receive injections once a week until their

Studie Overzicht

Toestand

Werving

Conditie

Interventie / Behandeling

Gedetailleerde beschrijving

This randomized, controlled, three-arm, parallel-group clinical trial will evaluate the efficacy and safety of intralesional vitamin D3 and intralesional methotrexate compared with intralesional saline placebo for plantar warts. The protocol describes the study as double-blind.

Participants will be recruited from the outpatient clinics of the Department of Dermatology and Venereology, Kafrelsheikh University Hospital, Egypt. Plantar warts will be diagnosed clinically, with dermoscopic examination used when the diagnosis is uncertain. Sixty eligible participants will be randomly assigned to three groups of 20 participants each.

Baseline evaluation will include medical history, wart duration, previous treatments, recurrence history, general examination, and assessment of wart size and number. Laboratory investigations will include a complete blood count, liver and kidney function tests, and serum calcium measurement before treatment and one week after the final treatment session.

Treatment sessions will take place weekly until complete clearance or a maximum of six sessions. Before injection, a topical lidocaine/prilocaine anesthetic cream will be applied under occlusion for one hour. The treatment area will then be cleaned with 70% alcohol. Assigned treatment will be injected into the base of the wart using a 27-gauge insulin syr

Studietype

Ingrijpend

Inschrijving (Geschat)

60

Fase

  • Niet toepasbaar

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 Locaties

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

18 jaar tot 50 jaar (Volwassen)

Accepteert gezonde vrijwilligers

Nee

Geslachten die in aanmerking komen voor studie

Allemaal

Beschrijving

Inclusion Criteria:

  • Age 18 to 50 years.
  • Clinical diagnosis of plantar warts, with dermoscopic confirmation when the diagnosis is uncertain.
  • Willingness to participate and provide written informed consent.

Exclusion Criteria:

  • Pregnancy or breastfeeding.
  • Use of systemic or topical treatments for warts within the month before enrollment.
  • Immunosuppressive diseases or current use of immunosuppressive drugs.
  • Hypercalcemia.
  • Renal disease or renal impairment.
  • Known hypersensitivity to any ingredient of the investigational products.
  • History of chronic disease, including hepatic disease or bleeding diathesis.
  • Local inflammation or infection.

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: Dubbele

Wapens en interventies

Deelnemersgroep / Arm
Interventie / Behandeling
Experimenteel: Intralesional Vitamin D3

Twenty participants will receive intralesional cholecalciferol (vitamin D3) injections into the base of plantar warts. A volume of 0.2-0.4 mL will be injected per lesion, treating a maximum of five warts per session. Sessions will take place weekly until complete clearance or a maximum of six sessions.
Geneesmiddel: Cholecalciferol (Vit D3)

Cholecalciferol will be administered by intralesional injection into the base of each treated plantar wart using a 27-gauge insulin syringe. The injection volume will be 0.2-0.4 mL per lesion, with a maximum of five warts treated per session. Treatment will be administered weekly until complete clearance or a maximum of six sessions.
Experimenteel: Intralesional Methotrexate

Twenty participants will receive intralesional methotrexate at a concentration of 25 mg/mL, injected into the base of each plantar wart until blanching occurs. A maximum of five warts will be treated per session. Sessions will take place weekly until complete clearance or a maximum of six sessions.
Geneesmiddel: Methotrexate

Methotrexate injection, supplied as 50 mg/2 mL and used at a concentration of 25 mg/mL, will be administered into the base of each treated plantar wart using a 27-gauge insulin syringe until blanching occurs. A maximum of five warts will be treated per session. Treatment will be administered weekly until complete clearance or a maximum of six sessions.
Placebo-vergelijker: Intralesional Saline Placebo

Twenty participants will receive intralesional saline injections into the base of plantar warts. Sessions will take place weekly until complete clearance or a maximum of six sessions.
Geneesmiddel: Saline Placebo

Saline will be administered as a placebo by intralesional injection into the base of plantar warts using a 27-gauge insulin syringe. Treatment will be administered weekly until complete clearance or a maximum of six sessions.

Wat meet het onderzoek?

Primaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Percentage of Participants Achieving Complete Clearance of Plantar Warts
Tijdsspanne: One month after the final treatment session

Complete response is defined as disappearance of plantar warts with restoration of normal-appearing skin, assessed by clinical and dermoscopic examination. The percentage of participants achieving complete response will be compared among treatment groups.
One month after the final treatment session

Secundaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Clinical and Dermoscopic Treatment Response Category
Tijdsspanne: One month after the final treatment session

Treatment response will be classified as complete response (appearance of normal skin), partial response (at least 50% but less than 100% reduction in original wart diameter and/or number), poor response (less than 50% reduction), or no response (no improvement). The distribution of participants across response categories will be compared among treatment groups.
One month after the final treatment session
Change From Baseline in Number of Plantar Warts
Tijdsspanne: Baseline, weekly during treatment for up to six sessions, and one month after the final treatment session

The number of plantar warts will be recorded by clinical examination. Change will be calculated relative to the baseline wart count. A decrease in wart number indicates improvement.
Baseline, weekly during treatment for up to six sessions, and one month after the final treatment session
Change From Baseline in Plantar Wart Diameter
Tijdsspanne: Baseline, weekly during treatment for up to six sessions, and one month after the final treatment session

Wart diameter will be measured using a ruler and compared with baseline measurements. A decrease in diameter indicates improvement.
Baseline, weekly during treatment for up to six sessions, and one month after the final treatment session
Change in Dermoscopic Features of Plantar Warts
Tijdsspanne: Baseline, weekly during treatment for up to six sessions, and one month after the final treatment session

Serial dermoscopic examinations and photographs will assess changes in black dots, red dots, and skin-line patterns within plantar wart lesions relative to baseline.
Baseline, weekly during treatment for up to six sessions, and one month after the final treatment session
Patient Satisfaction With Treatment Outcome
Tijdsspanne: One month after the final treatment session

Participants will categorize their satisfaction with the treatment outcome as not satisfied, slightly satisfied, or highly satisfied. The distribution of responses will be compared among treatment groups.
One month after the final treatment session
Percentage of Participants With Recurrence of Plantar Warts After Complete Clearance
Tijdsspanne: Through 3 months after the final treatment session

Among participants who achieve complete clearance, the percentage with reappearance of plantar warts during post-treatment follow-up will be reported.
Through 3 months after the final treatment session

Medewerkers en onderzoekers

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

Sponsor

Kafrelsheikh University

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 (Werkelijk)

1 augustus 2025

Primaire voltooiing (Geschat)

1 november 2026

Studie voltooiing (Geschat)

1 december 2026

Studieregistratiedata

Eerst ingediend

8 november 2026

Eerst ingediend dat voldeed aan de QC-criteria

8 november 2026

Eerst geplaatst (Werkelijk)

13 november 2026

Updates van studierecords

Laatste update geplaatst (Werkelijk)

13 november 2026

Laatste update ingediend die voldeed aan QC-criteria

8 november 2026

Laatst geverifieerd

1 november 2026

Meer informatie

Termen gerelateerd aan deze studie

Trefwoorden

Aanvullende relevante MeSH-voorwaarden

Andere studie-ID-nummers

  • KFSIRB200-655

Informatie over medicijnen en apparaten, studiedocumenten

Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel

Nee

Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct

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 .

Abonneren