An interventional study of Lactoferrin 2% Cream and Luliconazole 1% Cream in Tinea Corporis, sponsored by Kafrelsheikh University. Recruiting at 1 site in Egypt. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2026-11-13.
Sponsored by Kafrelsheikh University · Not applicable, Interventional, and Treatment
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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:
Participants will be assigned by chance to one of three groups:
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.
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.
40 studies on the registry are indexed under Tinea; 9 are open to participants now.
This study's planned enrollment of 100 is above the median of 70 across 34 interventional studies indexed under Tinea.
Browse Tinea studies →Kafrelsheikh University is the lead sponsor of 296 studies on the registry; 116 are open to participants now.
Of its 10 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hypersensitivity
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Immunosuppression
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Participants will apply topical lactoferrin 2% cream followed by topical luliconazole 1% cream to the affected areas twice daily for four weeks.
Drug: Lactoferrin 2% Cream · Drug: Luliconazole 1% Cream
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.
Drug: Luliconazole 1% Cream · Drug: Lactoferrin-Matching Placebo Cream
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.
Drug: Lactoferrin 2% Cream · Drug: Luliconazole-Matching Placebo 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.
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.
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.
Percentage of Participants Achieving Clinical Cure
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.
Time frame: Week 6 after treatment initiation (2 weeks after treatment completion)
Percentage of Participants Achieving Mycological Cure
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.
Time frame: Week 6 after treatment initiation (2 weeks after treatment completion)
Change From Baseline in Skin Lesion Area
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.
Time frame: Baseline and Weeks 1, 2, and 4 after treatment initiation
Change From Baseline in Pruritus Severity on a Visual Analog Scale
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.
Time frame: Baseline and Weeks 1, 2, and 4 after treatment initiation
Clinical Improvement Category
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.
Time frame: Week 4 after treatment initiation
Patient Satisfaction With Treatment
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.
Time frame: Week 4 after treatment initiation
Percentage of Participants With Recurrence Following Cure
Percentage of Participants With Recurrence Following Cure
Time frame: During the 4 weeks after treatment completion, through Week 8 after treatment initiation
Started Sep 2026 (actual). Primary completion is estimated for Jan 2027, 4 months after the start.
How these figures are worked out, and which studies are left out of them.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
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