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
調査の概要
状態
状態
条件
条件
介入・治療
介入・治療
詳細な説明
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
研究の種類
研究の種類
入学 (推定)
入学
段階
段階
- 適用できない
連絡先と場所
研究連絡先
研究連絡先
- 名前：Noura El seessy, MD, PhD
- 電話番号：+201000117186
- メール：Nora_Elsiesy@med.kfs.edu.eg
研究場所
-
-
-
Kafr ash Shaykh、エジプト
- 募集
- Kafrelsheikh University Hospital
-
コンタクト：
- Prof. Dr Reda Biomy, MD, PhD
- メール：medical_research@kfs.edu.eg
-
-
参加基準
適格基準
適格基準
就学可能な年齢
健康ボランティアの受け入れ
受講資格のある性別
説明
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.
研究計画
研究はどのように設計されていますか？
デザインの詳細
- 主な目的：処理
- 割り当て：ランダム化
- 介入モデル：並列代入
- マスキング：ダブル
アーム数
武器と介入
参加者グループ / アーム参加者グループ / アーム |
介入・治療介入・治療 |
|---|---|
|
実験的：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. |
|
実験的：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. |
|
プラセボコンパレーター：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. |
この研究は何を測定していますか？
主要な結果の測定
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Percentage of Participants Achieving Complete Clearance of Plantar Warts
時間枠：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
|
二次結果の測定
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Clinical and Dermoscopic Treatment Response Category
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
|
協力者と研究者
研究記録日
主要日程の研究
研究開始 (実際)
研究開始
一次修了 (推定)
一次修了
研究の完了 (推定)
研究の完了
試験登録日
最初に提出
最初に提出
QC基準を満たした最初の提出物
QC基準を満たした最初の提出物
最初の投稿 (実際)
最初の投稿
学習記録の更新
投稿された最後の更新 (実際)
投稿された最後の更新
QC基準を満たした最後の更新が送信されました
QC基準を満たした最後の更新が送信されました
最終確認日
最終確認日
詳しくは
本研究に関する用語
追加の関連 MeSH 用語
その他の研究ID番号
その他の研究ID番号
- KFSIRB200-655
医薬品およびデバイス情報、研究文書
米国FDA規制医薬品の研究
米国FDA規制機器製品の研究
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