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.
연구 개요
상태
정황
상세 설명
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.
연구 유형
등록 (추정된)
단계
- 해당 없음
연락처 및 위치
연구 연락처
- 이름: Noura El seessy, MD, PhD
- 전화번호: +201000117186
- 이메일: Nora_Elsiesy@med.kfs.edu.eg
연구 장소
-
-
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Kafr ash Shaykh, 이집트
- 모병
- Kafrelsheikh University Hospital
-
연락하다:
- Prof. Dr Reda Biomy, MD, PhD
- 이메일: medical_research@kfs.edu.eg
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참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
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.
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 치료
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 더블
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
|---|---|
|
실험적: 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. |
|
활성 비교기: 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. |
|
활성 비교기: 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. |
연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Percentage of Participants Achieving Clinical Cure
기간: 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
기간: 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)
|
2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Change From Baseline in Skin Lesion Area
기간: 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
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Change From Baseline in Pruritus Severity on a Visual Analog Scale
기간: 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
기간: 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
기간: 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
기간: 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
|
공동 작업자 및 조사자
연구 기록 날짜
연구 주요 날짜
연구 시작 (실제)
기본 완료 (추정된)
연구 완료 (추정된)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (실제)
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
이 연구와 관련된 용어
추가 관련 MeSH 약관
기타 연구 ID 번호
- KFSIRB200-1275
약물 및 장치 정보, 연구 문서
미국 FDA 규제 의약품 연구
미국 FDA 규제 기기 제품 연구
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