Topical Lactoferrin and Luliconazole, Alone or in Combination, for Tinea Corporis
Efficacy and Safety of Combined Topical Lactoferrin and Luliconazole Therapy Versus Topical Luliconazole Monotherapy in Egyptian Patients With Tinea Corporis: A Double-Blind Randomized Controlled Trial
This clinical trial will compare three cream treatments for tinea corporis, also called ringworm of the body. It will include Egyptian adults aged 18 to 65 years whose skin infection is confirmed by examining a skin scraping under a microscope.
The main questions are:
- Does using lactoferrin cream with luliconazole cream clear the infection better than either cream alone?
- What side effects occur with each treatment?
- Does the infection return after treatment?
Participants will be assigned by chance to one of three groups:
- Lactoferrin 2% cream and luliconazole 1% cream.
- Luliconazole 1% cream and a matching cream without lactoferrin.
- Lactoferrin 2% cream and a matching cream without luliconazole.
The matching creams contain no active study ingredient and help keep treatment assignments hidden. Participants and the researchers assessing their skin will not know which treatment each participant receives.
Participants will apply their assigned creams twice daily for four weeks. They will attend study visits for skin examinations, symptom assessments, and monitoring for side effects. Skin scrapings will be examined to check whether the infection has cleared. Researchers will also assess changes in the size of the affected areas, itching, treatment satisfaction, and whether the infection returns.
調査の概要
状態
条件
詳細な説明
This prospective, randomized, double-blind, parallel-group clinical trial will evaluate the efficacy and safety of topical lactoferrin 2% cream combined with topical luliconazole 1% cream compared with either agent alone in Egyptian adults with tinea corporis.
The study will be conducted at the outpatient clinics of the Department of Dermatology, Venereology and Andrology, Kafrelsheikh University Hospital, Egypt. Diagnosis will be established by clinical examination and confirmed by direct microscopic examination of skin scrapings using a 10% potassium hydroxide preparation. Written informed consent will be obtained before enrollment.
Eligible participants will be randomly assigned in a 1:1:1 ratio to combination therapy, luliconazole monotherapy with a matching lactoferrin vehicle cream, or lactoferrin monotherapy with a matching luliconazole vehicle cream. Participants and outcome assessors will remain unaware of treatment allocation. Active and matching vehicle creams will have identical appearance, consistency, packaging, and labeling.
Participants will apply their assigned creams to the affected areas twice daily for four weeks. In the combination group, lactoferrin cream will be applied before luliconazole cream. The corresponding application sequence will be maintained in the monotherapy groups using the matching vehicle creams. Additional topical or systemic antifungal treatment will not be permitted during the study.
Baseline assessments will include medical and treatment history, disease duration, previous recurrence, lesion number and location, lesion measurements, clinical photography, and assessment of itching. Subsequent assessments will evaluate treatment response, mycological findings, and adverse events.
The primary efficacy outcomes will be clinical cure and mycological cure. Clinical cure will be defined as complete disappearance of erythema, scaling, active lesion borders, and pruritus. Mycological cure will be defined as a negative potassium hydroxide examination.
Secondary assessments will include changes in lesion size, itching severity measured using a 10-cm visual analog scale, categorical clinical improvement, patient satisfaction, and recurrence after treatment. Recurrence will be assessed as clinical and/or mycological reappearance of infection.
Safety monitoring will include burning, erythema, irritation, pruritus, edema, hyperpigmentation, and other adverse events. The severity of adverse events and their relationship to study treatment will be documented.
研究の種類
入学 (推定)
段階
- 適用できない
連絡先と場所
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
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:
- Male or female patients aged 18 to 65 years.
- Clinical diagnosis of tinea corporis.
- Confirmation of dermatophytosis by direct microscopic examination using a potassium hydroxide (KOH) preparation.
- Willingness to participate and provide written informed consent.
Exclusion Criteria:
- Known hypersensitivity to lactoferrin, luliconazole, or any component of the study formulations.
- Pregnancy or breastfeeding.
- Use of systemic or topical antifungal therapy within 4 weeks before enrollment.
- Use of systemic or topical corticosteroids within 4 weeks before enrollment.
- Immunocompromised status.
- Current treatment with immunosuppressive therapy.
- Other dermatological conditions that may interfere with clinical assessment.
- Severe systemic diseases that may affect study outcomes.
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
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
|
実験的：Lactoferrin Plus Luliconazole
Participants will apply topical lactoferrin 2% cream followed by topical luliconazole 1% cream to the affected areas twice daily for four weeks. |
Topical cream containing lactoferrin 2% w/w, prepared in the Pharmaceutics Laboratory, Faculty of Pharmacy, Kafrelsheikh University. Applied to the affected areas twice daily for four weeks, before luliconazole cream or its matching placebo, according to treatment allocation. Topical cream containing luliconazole 1% w/w. Applied to the affected areas twice daily for four weeks, after lactoferrin cream or its matching placebo, according to treatment allocation. |
|
アクティブコンパレータ：Luliconazole Monotherapy
Participants will apply a vehicle cream matching the lactoferrin formulation, followed by topical luliconazole 1% cream, to the affected areas twice daily for four weeks. |
Topical cream containing luliconazole 1% w/w. Applied to the affected areas twice daily for four weeks, after lactoferrin cream or its matching placebo, according to treatment allocation. Vehicle cream without lactoferrin, matching the active lactoferrin cream in appearance, consistency, packaging, and labeling. Applied to the affected areas twice daily for four weeks before luliconazole 1% cream. |
|
アクティブコンパレータ：Lactoferrin Monotherapy
Participants will apply topical lactoferrin 2% cream followed by a vehicle cream matching the luliconazole formulation to the affected areas twice daily for four weeks. |
Topical cream containing lactoferrin 2% w/w, prepared in the Pharmaceutics Laboratory, Faculty of Pharmacy, Kafrelsheikh University. Applied to the affected areas twice daily for four weeks, before luliconazole cream or its matching placebo, according to treatment allocation. Vehicle cream without luliconazole, matching the active luliconazole cream in appearance, consistency, packaging, and labeling. Applied to the affected areas twice daily for four weeks after lactoferrin 2% cream. |
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 |
|---|---|---|
|
Percentage of Participants Achieving Clinical Cure
時間枠：Week 6 after treatment initiation (2 weeks after treatment completion)
|
Clinical cure is defined as complete disappearance of erythema, scaling, active lesion borders, and pruritus associated with tinea corporis. The percentage of participants meeting all clinical cure criteria will be compared among treatment groups. |
Week 6 after treatment initiation (2 weeks after treatment completion)
|
|
Percentage of Participants Achieving Mycological Cure
時間枠：Week 6 after treatment initiation (2 weeks after treatment completion)
|
Mycological cure is defined as a negative direct microscopic examination of skin scrapings using a 10% potassium hydroxide preparation. The percentage of participants with a negative examination will be compared among treatment groups. |
Week 6 after treatment initiation (2 weeks after treatment completion)
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Change From Baseline in Skin Lesion Area
時間枠：Baseline and Weeks 1, 2, and 4 after treatment initiation
|
Lesion length and width will be measured using a Vernier caliper to assess change in lesion area from baseline. A reduction in lesion area indicates improvement. |
Baseline and Weeks 1, 2, and 4 after treatment initiation
|
|
Change From Baseline in Pruritus Severity on a Visual Analog Scale
時間枠：Baseline and Weeks 1, 2, and 4 after treatment initiation
|
Pruritus severity will be assessed using a 10-cm visual analog scale. Participants will mark the intensity of itching experienced during the preceding 24 hours on a line ranging from 0 (no pruritus) to 10 (worst imaginable pruritus). The distance from the left end to the participant's mark will be recorded in centimeters. A decrease from baseline indicates improvement. |
Baseline and Weeks 1, 2, and 4 after treatment initiation
|
|
Clinical Improvement Category
時間枠：Week 4 after treatment initiation
|
Clinical response will be categorized as marked improvement, improvement, slight improvement, no change, or aggravation. The distribution of participants across these categories will be compared among treatment groups. |
Week 4 after treatment initiation
|
|
Patient Satisfaction With Treatment
時間枠：Week 4 after treatment initiation
|
Participants will rate their satisfaction with treatment as not satisfied, slightly satisfied, or highly satisfied. The distribution of responses will be compared among treatment groups. |
Week 4 after treatment initiation
|
|
Percentage of Participants With Recurrence Following Cure
時間枠：During the 4 weeks after treatment completion, through Week 8 after treatment initiation
|
Percentage of Participants With Recurrence Following Cure |
During the 4 weeks after treatment completion, through Week 8 after treatment initiation
|
協力者と研究者
スポンサー
研究記録日
主要日程の研究
研究開始 (実際)
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
- KFSIRB200-1275
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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