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Topical Lactoferrin and Luliconazole, Alone or in Combination, for Tinea Corporis

8 novembre 2026 mis à jour par: Noura Abdelmoneim Mohammed Elseessy, Kafrelsheikh University

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.

Aperçu de l'étude

Statut

Recrutement

Les conditions

Intervention / Traitement

Description détaillée

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.

Type d'étude

Interventionnel

Inscription (Estimé)

100

Phase

  • N'est pas applicable

Contacts et emplacements

Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.

Coordonnées de l'étude

Lieux d'étude

Critères de participation

Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.

Critère d'éligibilité

Âges éligibles pour étudier

18 ans à 65 ans (Adulte, Adulte plus âgé)

Accepte les volontaires sains

Non

Sexes éligibles pour l'étude

Tout

La description

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.

Plan d'étude

Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.

Comment l'étude est-elle conçue ?

Détails de conception

  • Objectif principal: Traitement
  • Répartition: Randomisé
  • Modèle interventionnel: Affectation parallèle
  • Masquage: Double

Armes et Interventions

Groupe de participants / Bras
Intervention / Traitement
Expérimental: 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.
Médicament: Lactoferrin 2% Cream

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.

Médicament: Luliconazole 1% Cream

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.
Comparateur actif: 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.
Médicament: Luliconazole 1% Cream

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.

Médicament: Lactoferrin-Matching Placebo Cream

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.
Comparateur actif: 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.
Médicament: Lactoferrin 2% Cream

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.

Médicament: Luliconazole-Matching Placebo Cream

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.

Que mesure l'étude ?

Principaux critères de jugement

Mesure des résultats
Description de la mesure
Délai
Percentage of Participants Achieving Clinical Cure
Délai: 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
Délai: 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)

Mesures de résultats secondaires

Mesure des résultats
Description de la mesure
Délai
Change From Baseline in Skin Lesion Area
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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

Collaborateurs et enquêteurs

C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.

Parrainer

Kafrelsheikh University

Dates d'enregistrement des études

Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.

Dates principales de l'étude

Début de l'étude (Réel)

1 septembre 2026

Achèvement primaire (Estimé)

1 janvier 2027

Achèvement de l'étude (Estimé)

1 janvier 2027

Dates d'inscription aux études

Première soumission

8 novembre 2026

Première soumission répondant aux critères de contrôle qualité

8 novembre 2026

Première publication (Réel)

13 novembre 2026

Mises à jour des dossiers d'étude

Dernière mise à jour publiée (Réel)

13 novembre 2026

Dernière mise à jour soumise répondant aux critères de contrôle qualité

8 novembre 2026

Dernière vérification

1 novembre 2026

Plus d'information

Termes liés à cette étude

Mots clés

Termes MeSH pertinents supplémentaires

Autres numéros d'identification d'étude

  • KFSIRB200-1275

Informations sur les médicaments et les dispositifs, documents d'étude

Étudie un produit pharmaceutique réglementé par la FDA américaine

Non

Étudie un produit d'appareil réglementé par la FDA américaine

Non

Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .

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