A Phase 1b Study of ZYG24004 in Participants With Tinea Pedis Caused by Dermatophytes
ConditionTinea Pedis
Trial statusNot yet recruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18-65
SponsorSinomune Pharmaceutical Co., Ltd
About this trial
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.
Eligibility criteria
Qualifiers
Male or female participants aged 18 to 65 years; body weight >=50 kg for males and >=45 kg for females; body mass index (BMI) 18.5 to 28.0 kg/m2, inclusive.
Clinically diagnosed tinea pedis, with lesions located in the interdigital area and possibly involving the sole and lateral foot.
Positive mycological test of the target foot at screening, based on fungal microscopy.
Target-foot clinical signs and symptoms score >=3.
Disqualifiers
Hyperkeratotic tinea pedis, or tinea pedis accompanied by erosion, exudation, or ulceration.
Concomitant onychomycosis of the feet or other active fungal disease.
Bacterial or viral skin infection of the feet, or severe skin disease judged by the investigator to affect study assessments, such as severe eczema, psoriasis, atopic dermatitis, or chronic dermatitis.
History of dermatophyte infection that was ineffective to prior antifungal therapy.
Trial design
Treatments tested in this trial
- ZYG24004 1% topical film-forming formulation
- ZYG24004 3% topical film-forming formulation
- Placebo topical formulation
Treatment groups
64 Participants
are divided into 8 treatment groups8
Treatment groupsSee each treatment group below.
Sponsors and collaborators
Source ClinicalTrials.gov