A MULTICENTER, RANDOMIZED, DOUBLE-BLIND, PARALLEL, VEHICLE-CONTROLLED STUDY TO EVALUATE THE EFFICACY AND SAFETY OF P-3058 10% NAIL SOLUTION IN THE TREATMENT OF ONYCHOMYCOSIS

Polichem S.A.0 个研究点目标入组 953 人开始时间: 2016年12月15日最近更新: 2022年1月24日

适应症

试验速览

暂无简介。

•1)Written informed consent before starting any study related procedures.
•2)Patients aged 12 years and older of any race.
•3)Males or females.
•4)Outpatients.
•5)Clinically diagnosed mild-to-moderate distal lateral subungual onychomycosis (DLSO) of at least one big toenail (the target nail) at the Screening visit (V1), confirmed by the Independent Panel of Reviewers.
•6)Patients with onychomycosis involving = 20% to = 50% of the area of the target big toenail.
•7)Patients with a positive KOH examination in the screening target big toenail sample.
•8)Patients with positive culture for dermatophyte(s) or positive mixed dermatophyte(s)/Candida culture in the screening target big toenail sample.
•9)Evidence of target big toenail growth reported by the patient defined as at least monthly nail clipping.
•Are the trial subjects under 18? yes
•Number of subjects for this age range: 5
•F.1.2 Adults (18-64 years) yes
•F.1.2.1 Number of subjects for this age range 590
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range 390

•- Woman who is pregnant, nursing an infant, or planning a pregnancy during the study period.
•- Presence of yellow spikes” (defined as longitudinal streak extending from the free edge of the nail to the proximal edge) on the target nail.
•- Presence of dermatophytoma (defined as thick masses of fungal hyphae and necrotic keratin between the nail plate and nail bed) on the target nail.
•- Presence of nail thickness exceeding 2 mm.
•- Patients with proximal subungual involvement (marker of immunosuppressed patient).
•- Patients with severe plantar or moccasin tinea pedis (defined by blistering, pustules or inability to ambulate).
•- Patients with nail abnormalities due to conditions like psoriasis, lichen planus, immune dysfunction, collagen-vascular diseases, peripheral vascular disease.
•- Patients with life expectancy less than 2 years.
•- Chemotherapy, immunosuppressive therapy in the 12 weeks prior to Screening visit (V1).
•- Systemic corticosteroids, antimetabolites and immune-stimulants therapy in the 4 weeks prior to Screening visit (V1).
•- HIV infection or any other immunodeficiency.
•- Alcohol or substance abuse.
•- Patients with history of allergic reactions to terbinafine or amorolfine or to their excipients.

发起方

Polichem S.A.