Tinea Pedis

This is a multicenter, randomized, double-blind, placebo-controlled Phase 1b study in adult participants with tinea pedis caused by dermatophytes. The study will evaluate the safety, local tolerability, and pharmacokinetic profile of two concentrations of ZYG24004 (1% and 3%) after topical administration once or twice (once weekly for two consecutive weeks), and will explore preliminary efficacy.

Tinea pedis (athlete's foot) is a common and highly contagious fungal infection of the feet. Moderate-to-severe cases present with extensive skin lesions, severe symptoms, frequent recurrences, and increased risk of complications, often proving refractory to conventional topical therapies. Anatomical niches, poor drug penetration, and antifungal resistance make effective management challenging and negatively impact patients' quality of life. Current treatments, including topical and systemic antifungals or physical modalities, are often limited by incomplete efficacy, complexity, or poor adherence. Therefore, more effective and practical treatment options are urgently needed. Atmospheric pressure cold plasma (CAP) is an innovative technology that generates reactive species capable of targeting pathogens while preserving normal tissue. CAP has demonstrated strong antimicrobial effects and promotes wound healing in biomedical research. This study will evaluate the efficacy and safety of CAP in treating moderate-to-severe tinea pedis, aiming to address unmet clinical needs and support future clinical application.

This study is designed to evaluate the safety and effectiveness of multiple 1% tolnaftate formulations delivered through novel stick-based vehicles in individuals with tinea pedis (athlete's foot).

This randomized controlled trail study will be carried out on OPD patients in the Department of Dermatology, Jinnah Postgraduate Medical Center. Institutional Ethical committee permission will be obtained and clinical trial registration number (CTN) will be obtained for the study. Written consent will obtained from all the participants of the study. All the diagnosed patients of Tinea Pedis who will meet the selection criteria will be enrolled and will be educated regarding the study. Participants will be randomly allocated in into two groups utilizing envelop method; patients of Group-A will use topical Sertaconazole 2% and patients in Group-B will use Clotrimazole 1%. Randomization: Random number sequence will be generated on computer by a simple randomization schedule. Each randomization number will be sealed in an opaque envelope with a serial number on it. The patient with a known serial number opened the corresponding envelope to be informed of the assignment. Treatment: After cleaning the identified lesions, the patients will topically self-apply the both products/creams using a cotton swab applicator, where the applied amount will be able to make the lesions be covered with a thin layer of medication. Both the creams will be applied topically twice daily for 4 weeks. Patients will be followed up weekly for clinical improvement and side-effects of therapy upto 4 weeks of the treatment. At final follow up (after 4 week of treatment), the patients will be evaluated by all clinical investigations and microscopic examination (10% potassium hydroxide) of a skin scraping from site of the lesion. Adverse effects of the drugs among all patients will also be recorded. The photograph of the lesions taken before treatment and at the end of the study will be used for assessing the clinical improvement of the cases. Detailed questionnaires will be followed regarding demographic and clinical characteristics like age, BMI, symptoms and co morbidities etc. Proper selection criteria will be used to control any biasness. Efficacy will be reported as per operational definition. In case of, topical therapy will be terminated and the concerned patient will be switched over to an oral antifungal drug at the discretion of the dermatologist. Any adverse events during the study will also be reported.