Vitamin D3 Versus Methotrexate Versus Saline Injections for Plantar Warts
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
Studienübersicht
Status
Bedingungen
Intervention / Behandlung
Detaillierte Beschreibung
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
Studientyp
Einschreibung (Geschätzt)
Phase
- Unzutreffend
Kontakte und Standorte
Studienkontakt
- Name: Noura El seessy, MD, PhD
- Telefonnummer: +201000117186
- E-Mail: Nora_Elsiesy@med.kfs.edu.eg
Studienorte
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Kafr ash Shaykh, Ägypten
- Rekrutierung
- Kafrelsheikh University Hospital
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Kontakt:
- Prof. Dr Reda Biomy, MD, PhD
- E-Mail: medical_research@kfs.edu.eg
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Teilnahmekriterien
Zulassungskriterien
Studienberechtigtes Alter
Akzeptiert gesunde Freiwillige
Studienberechtigte Geschlechter
Beschreibung
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.
Studienplan
Wie ist die Studie aufgebaut?
Designdetails
- Hauptzweck: Behandlung
- Zuteilung: Zufällig
- Interventionsmodell: Parallele Zuordnung
- Maskierung: Doppelt
Waffen und Interventionen
Teilnehmergruppe / Arm |
Intervention / Behandlung |
|---|---|
|
Experimental: 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. |
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. |
|
Experimental: 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. |
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-Komparator: 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. |
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. |
Was misst die Studie?
Primäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
|
Percentage of Participants Achieving Complete Clearance of Plantar Warts
Zeitfenster: One month after the final treatment session
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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
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Sekundäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
|
Clinical and Dermoscopic Treatment Response Category
Zeitfenster: 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
|
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Change From Baseline in Number of Plantar Warts
Zeitfenster: Baseline, weekly during treatment for up to six sessions, and one month after the final treatment session
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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
|
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Change From Baseline in Plantar Wart Diameter
Zeitfenster: 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
|
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Change in Dermoscopic Features of Plantar Warts
Zeitfenster: 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
|
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Patient Satisfaction With Treatment Outcome
Zeitfenster: One month after the final treatment session
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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
|
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Percentage of Participants With Recurrence of Plantar Warts After Complete Clearance
Zeitfenster: 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
|
Mitarbeiter und Ermittler
Sponsor
Studienaufzeichnungsdaten
Haupttermine studieren
Studienbeginn (Tatsächlich)
Primärer Abschluss (Geschätzt)
Studienabschluss (Geschätzt)
Studienanmeldedaten
Zuerst eingereicht
Zuerst eingereicht, das die QC-Kriterien erfüllt hat
Zuerst gepostet (Tatsächlich)
Studienaufzeichnungsaktualisierungen
Letztes Update gepostet (Tatsächlich)
Letztes eingereichtes Update, das die QC-Kriterien erfüllt
Zuletzt verifiziert
Mehr Informationen
Begriffe im Zusammenhang mit dieser Studie
Schlüsselwörter
Zusätzliche relevante MeSH-Bedingungen
- Heterocyclische Verbindungen
- Heterocyclische Verbindungen, 2-Ring
- Heterocyclische Verbindungen, Fusionsring
- Lipide
- Polycyclische Verbindungen
- Steroide
- Fusions-Ring-Verbindungen
- Pterins
- Pteridine
- Aminopterin
- Cholestene
- Cholestanes
- Sterole
- Vitamin d
- Secosteroide
- Membranlipide
- Methotrexat
- Cholecalciferol
Andere Studien-ID-Nummern
- KFSIRB200-655
Arzneimittel- und Geräteinformationen, Studienunterlagen
Studiert ein von der US-amerikanischen FDA reguliertes Arzneimittelprodukt
Studiert ein von der US-amerikanischen FDA reguliertes Geräteprodukt
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