Comparison of Itraconazole With Itraconazole and Isotretinoin in the Treatment Duration, Safety a n d Cure Rate in Adult Patients of Tinea Corporis/ Cruris-A Randomised Controlled Trail
Comparison of Itraconazole With Itraconazole and Isotretinoin in the Treatment Duration, Safety, and Cure Rate in Adult Patients With Tinea Corporis/Cruris: A Randomized Controlled Trial.
Tinea corporis and tinea cruris are common superficial fungal infections that have become increasingly difficult to treat because of prolonged disease duration, frequent recurrences, and suboptimal response to standard antifungal therapy. Itraconazole is widely used for the treatment of dermatophytosis; however, treatment failures and relapses remain a significant concern. Isotretinoin has been proposed as an adjuvant therapy because of its effects on epidermal differentiation, keratinization, and follicular function, which may enhance antifungal penetration and improve treatment outcomes.
This randomized controlled trial aims to compare itraconazole monotherapy with a combination of itraconazole and isotretinoin in adult patients with tinea corporis and/or tinea cruris. The study will evaluate treatment duration, cure rate, and safety profile of both regimens. The findings may provide evidence regarding the potential benefit of adding isotretinoin to conventional antifungal therapy and help optimize management strategies for adult patients with dermatophytosis.
調査の概要
研究の種類
入学 (推定)
段階
- フェーズ 4
連絡先と場所
研究連絡先
- 名前：Maria Ahmed, MBBS
- 電話番号：+9236666630
- メール：mariafazeelkhan@gmail.com
研究場所
-
-
Punjab Province
-
Rawalpindi、Punjab Province、パキスタン、46000
- PakEmirates
-
コンタクト：
- Moizza Tahir, MBBS
- 電話番号：+923000113959
- メール：mariafazeelkhan@gmail.com
-
主任研究者：
- Maria Ahmed, MBBS
-
-
参加基準
適格基準
就学可能な年齢
- 子
- 大人
- 高齢者
健康ボランティアの受け入れ
説明
Inclusion Criteria:
- Al newly diagnosed cases with typical tinea lesion involving at least 5% body surface area (BSA) with no nail/scalp/palm/sole involvement and no history of intake of any oral antifungal in the preceding 4 weeks or of a topical antifungal/steroid in the preceding 2 weeks. Presenting to the outpatient department or the emergency department of PEMH or CMH will be included in the study.
Exclusion Criteria:
- 1. Patients with chronic liver and renal diseases. 2. Patients with ischaemic heart diseases. 3. Patients with hyperlipidemia. 4. 5. Those on chronic immunosuppressive therapy. Pregnant and lactating women and females of reproductive age. 6. Elderly patients above 75 years 7. Patient who had taken oral antifungal in the preceding 4 weeks or of a topical antifungal/steroid in the preceding 2 weeks
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：独身
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
|
アクティブコンパレータ：Oral itraconazol 200mg
Participants receive oral itraconazole according to the study protocol for the treatment of tinea corporis/cruris.
Clinical and mycological responses are assessed during follow-up.
|
Oral itraconazole 200 mg daily administered to adult patients with tinea corporis/cruris.
Treatment is continued according to the study protocol, and participants are monitored for clinical improvement, mycological cure, adverse events, and recurrence.
|
|
実験的：Itraconazole Plus Isotretinoin
Participants receive oral itraconazole in combination with low-dose oral isotretinoin according to the study protocol for the treatment of tinea corporis/cruris.
Clinical and mycological responses are assessed during follow-up.
|
Oral itraconazole 200 mg daily administered to adult patients with tinea corporis/cruris.
Treatment is continued according to the study protocol, and participants are monitored for clinical improvement, mycological cure, adverse events, and recurrence.
Oral isotretinoin 20 mg daily administered in combination with oral itraconazole 200 mg daily to adult patients with tinea corporis/cruris.
Participants are monitored for treatment response, mycological cure, adverse events, and recurrence according to the study protocol.
|
この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Treatment Duration to Complete Cure
時間枠：8 weeks
|
Treatment duration (in weeks) required to achieve complete cure, defined as complete clinical resolution of signs and symptoms of tinea corporis/cruris along with negative KOH microscopy.
The outcome will be compared between the itraconazole monotherapy group and the itraconazole plus isotretinoin group.
|
8 weeks
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Treatment related adverse events
時間枠：8 weeks
|
Frequency and severity of adverse events associated with treatment, including headache, abdominal pain, mucocutaneous dryness, jaundice, liver function test abnormalities, lipid profile abnormalities, and thyroid function abnormalities.
|
8 weeks
|
協力者と研究者
出版物と役立つリンク
研究記録日
主要日程の研究
研究開始 (推定)
一次修了 (推定)
研究の完了 (推定)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (実際)
学習記録の更新
投稿された最後の更新 (実際)
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
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
- A/28/ERC/09/2026
個々の参加者データ (IPD) の計画
個々の参加者データ (IPD) を共有する予定はありますか?
IPD プランの説明
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
米国で製造され、米国から輸出された製品。
この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。