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

8. November 2026 aktualisiert von: 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.

Studienübersicht

Status

Rekrutierung

Bedingungen

Intervention / Behandlung

Detaillierte Beschreibung

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.

Studientyp

Interventionell

Einschreibung (Geschätzt)

100

Phase

  • Unzutreffend

Kontakte und Standorte

Dieser Abschnitt enthält die Kontaktdaten derjenigen, die die Studie durchführen, und Informationen darüber, wo diese Studie durchgeführt wird.

Studienkontakt

Studienorte

Teilnahmekriterien

Forscher suchen nach Personen, die einer bestimmten Beschreibung entsprechen, die als Auswahlkriterien bezeichnet werden. Einige Beispiele für diese Kriterien sind der allgemeine Gesundheitszustand einer Person oder frühere Behandlungen.

Zulassungskriterien

Studienberechtigtes Alter

18 Jahre bis 65 Jahre (Erwachsene, Älterer Erwachsener)

Akzeptiert gesunde Freiwillige

Nein

Studienberechtigte Geschlechter

Alle

Beschreibung

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.

Studienplan

Dieser Abschnitt enthält Einzelheiten zum Studienplan, einschließlich des Studiendesigns und der Messung der Studieninhalte.

Wie ist die Studie aufgebaut?

Designdetails

  • Hauptzweck: Behandlung
  • Zuteilung: Zufällig
  • Interventionsmodell: Parallele Zuordnung
  • Maskierung: Doppelt

Waffen und Interventionen

Teilnehmergruppe / Arm
Intervention / Behandlung
Experimental: 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.
Arzneimittel: 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.

Arzneimittel: 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.
Aktiver Komparator: 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.
Arzneimittel: 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.

Arzneimittel: 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.
Aktiver Komparator: 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.
Arzneimittel: 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.

Arzneimittel: 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.

Was misst die Studie?

Primäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Percentage of Participants Achieving Clinical Cure
Zeitfenster: 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
Zeitfenster: 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)

Sekundäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Change From Baseline in Skin Lesion Area
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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

Mitarbeiter und Ermittler

Hier finden Sie Personen und Organisationen, die an dieser Studie beteiligt sind.

Sponsor

Kafrelsheikh University

Studienaufzeichnungsdaten

Diese Daten verfolgen den Fortschritt der Übermittlung von Studienaufzeichnungen und zusammenfassenden Ergebnissen an ClinicalTrials.gov. Studienaufzeichnungen und gemeldete Ergebnisse werden von der National Library of Medicine (NLM) überprüft, um sicherzustellen, dass sie bestimmten Qualitätskontrollstandards entsprechen, bevor sie auf der öffentlichen Website veröffentlicht werden.

Haupttermine studieren

Studienbeginn (Tatsächlich)

1. September 2026

Primärer Abschluss (Geschätzt)

1. Januar 2027

Studienabschluss (Geschätzt)

1. Januar 2027

Studienanmeldedaten

Zuerst eingereicht

8. November 2026

Zuerst eingereicht, das die QC-Kriterien erfüllt hat

8. November 2026

Zuerst gepostet (Tatsächlich)

13. November 2026

Studienaufzeichnungsaktualisierungen

Letztes Update gepostet (Tatsächlich)

13. November 2026

Letztes eingereichtes Update, das die QC-Kriterien erfüllt

8. November 2026

Zuletzt verifiziert

1. November 2026

Mehr Informationen

Begriffe im Zusammenhang mit dieser Studie

Schlüsselwörter

Zusätzliche relevante MeSH-Bedingungen

Andere Studien-ID-Nummern

  • KFSIRB200-1275

Arzneimittel- und Geräteinformationen, Studienunterlagen

Studiert ein von der US-amerikanischen FDA reguliertes Arzneimittelprodukt

Nein

Studiert ein von der US-amerikanischen FDA reguliertes Geräteprodukt

Nein

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