CICLOPIROX for Onychomycosis

Inclusion criteria

• {"criterion_text":"- informed consent before starting any procedure related to the study."}
• {"criterion_text":"- Adult men and women aged ≥18 to ≤75 years at the time of inclusion"}
• {"criterion_text":"- Patients diagnosed with mild to moderate distal onychomycosis due to dermatophyte fungi with nail involvement between 10% and 40% at the time of inclusion."}
• {"criterion_text":"- Patients diagnosed with onychomycosis in the last 6 months"}
• {"criterion_text":"- Women of childbearing potential must have a negative urine pregnancy test (fertile is defined from menarche to postmenopause, unless sterilized by hysterectomy, bilateral salpingectomy, and bilateral oophorectomy) and be willing to use contraception. effective from 14 days before the first administration until 4 weeks after the last administration of the investigational medication."}

Exclusion criteria

• {"criterion_text":"- Hypersensitivity tociclopirox or any component of nail varnish."}
• {"criterion_text":"- Onychomycosis caused by non-dermatophytic yeasts or molds"}
• {"criterion_text":"- Hyperkeratotic-squamous dermatomycosis of the foot"}
• {"criterion_text":"- Mucocutaneous candidiasis."}
• {"criterion_text":"- Patients with any medical or psychological condition that, in the discretion of the investigator, may interfere with the patient's ability to comply with study procedures"}
• {"criterion_text":"- Patients who have participated in a clinical trial with an experimental drug or medical device in the last 3 months."}
• {"criterion_text":"- Pregnant or breastfeeding women"}
• {"criterion_text":"- Systemic antifungal drugs in the 6 months prior to the start of the study, or need for them."}
• {"criterion_text":"- Topical antifungal drugs within 4 weeks prior to the start of the study."}
• {"criterion_text":"- Chemotherapy in the 12 weeks prior to the start of the study or need for it."}
• {"criterion_text":"- Subjects with a diagnosis of psoriasis or other nail pathology with plate involvement."}
• {"criterion_text":"- Patients with uncontrolled diabetes mellitus (DM)."}
• {"criterion_text":"- Patients with suspected or evidence of severe liver or kidney disease."}
• {"criterion_text":"- Acquired Immune Deficiency Syndrome (AIDS) or any other immunodeficiency."}

Primary endpoints

• {"endpoint_text":"- The clinical evolution of onychomycosis will be evaluated through the mean change in the Onychomycosis Severity Index (OSI) from baseline to 12, 24, 36, 48 and 52 weeks.","definition_or_measurement_approach":"Mean change in the Onychomycosis Severity Index (OSI) from baseline to weeks 12, 24, 36, 48 and 52."}

Secondary endpoints

• {"endpoint_text":"- The evolution of the quality of life of patients with onychomycosis will be evaluated through the mean change in the Dermatology Life Quality Index (DLQI) from baseline to 12, 36, 48 and 52 weeks. The DLQI will be performed at all study visits until clinical success is achieved or after the end of the follow-up period, which will take place within 4 weeks after the last treatment visit, with a maximum period of 52 weeks.","definition_or_measurement_approach":"Mean change in the Dermatology Life Quality Index (DLQI) from baseline to weeks 12, 36, 48 and 52; DLQI performed at each visit until clinical success or end of follow-up (max 52 weeks)."}
• {"endpoint_text":"- Clinical success in patients with onychomycosis will be evaluated according to the percentage of patients in whom a decrease in the area of ​​the diseased nail has been observed < 10% of the total of the first toe evaluated by the investigator using photographic image from the baseline moment until 12, 24, 36, 48 and 52 weeks.","definition_or_measurement_approach":"Proportion of patients with reduction in diseased nail area to <10% of the first toe, assessed by investigator using photographic images at baseline and weeks 12, 24, 36, 48 and 52."}
• {"endpoint_text":"- Clinical improvement in patients with onychomycosis will be evaluated according to the percentage of patients in whom at least a 20% decrease in the affected area of ​​the nail of the first toe has been observed evaluated by the investigator using photographic image from the baseline moment until 12, 24, 36, 48 and 52 weeks.","definition_or_measurement_approach":"Proportion of patients with ≥20% decrease in affected area of the first toe nail by investigator photographic assessment at baseline and weeks 12, 24, 36, 48 and 52."}
• {"endpoint_text":"- The time necessary to achieve clinical success will be evaluated according to the number of weeks of treatment that patients have required to achieve clinical success defined as the reduction of the diseased nail area < 10% of the total of the first toe. foot.","definition_or_measurement_approach":"Time (weeks) from baseline to first assessment meeting clinical success (diseased nail area <10% of first toe)."}
• {"endpoint_text":"- Mycological cure will be evaluated by the negativization rate of the PCR test in the 4 weeks after the end of treatment. Therefore, PCR will be performed within 4 weeks of the last treatment visit, which will occur at 52 weeks, or within 4 weeks of the last visit at which clinical success was achieved. In the PCR examination, the presence of dermatophyte fungi that cause onychomycosis will be analyzed as an evaluation criterion.","definition_or_measurement_approach":"Rate of PCR negativity for dermatophyte fungi within 4 weeks after end of treatment or within 4 weeks of the visit when clinical success was achieved."}
• {"endpoint_text":"- The evolution of the patient's perception regarding nail alterations will be evaluated through the average change in the questionnaire for the subjective evaluation of the patient at 12, 36, 48 and 52 weeks of follow-up.","definition_or_measurement_approach":"Mean change in a patient subjective questionnaire for nail alterations at weeks 12, 36, 48 and 52."}
• {"endpoint_text":"- The safety profile of treatment with DexULac® will be evaluated according to the total number and frequency of Adverse Events (AEs), serious AEs (SAEs) and Adverse Reactions (ARs) from baseline to 48 weeks of treatment. In addition, the safety profile will be evaluated according to the number and percentage of patients who have experienced at least one of the mentioned events during the 48 weeks of treatment. The severity and causality of each event will also be evaluated.","definition_or_measurement_approach":"Safety assessed by counts and frequencies of AEs, SAEs and ARs from baseline to 48 weeks; number and percentage of patients with ≥1 event; severity and causality evaluated."}

Spain

Earliest CTIS Part Ii Submission Date

13-02-2025

Latest Decision Or Authorization Date

21-11-2025

Processing Time Days

281

Number Of Sites

11

Number Of Participants

100

Primary sponsor

Full Name

Laboratorio Reig Jofre S.A.

Organisation Type

Pharmaceutical company

Country Of Registered Address

Spain