EUCTR2015-000561-31-GR进行中（未招募）1 期
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 840 人开始时间: 2015年11月5日最近更新:
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 840
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •1. Written informed consent before starting any study related
- •procedures.
- •2. Patients aged 12 to 80 years old 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: 100
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 420
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 320
排除标准
- •1. Woman who is pregnant, nursing an infant, or planning a
- •pregnancy during the study period
- •2. Patients with history of allergic reactions to terbinafine or its
- •excipients.
- •3. Use of any investigational drug/device or participation in a
- •previous clinical trial within four weeks prior to Screening visit (V1).
- •4. Patients using nail polish or other nail cosmetic product on the
- •concerned nails from at least 24 hours prior to Screening visit
- •(V1) until the end of the study.
- •5. Use of systemic antifungal drugs in the 24 weeks prior to
- •Screening visit (V1) or non–responsive to systemic antifungal
- •therapy for onychomycosis.
- •6. Nail application of topical antifungal drugs or device in the 4
- •weeks prior to Screening visit (V1).
- •7. Presence of any nail infections other than dermatophyte as
- •determined by the Investigator (Candida onychomycosis
- •infection concurrent with positive dermatophyte culture is
- •acceptable).
- •8. Presence of onychodystrophy that could interfere with clinical
- •assessments as determined by the Investigator.
- •9. Presence of yellow spikes” (defined as longitudinal streak
- •extending from the free edge of the nail to the proximal edge) on
- •the target nail.
- •10. Presence of dermatophytoma (defined as thick masses of fungal
- •hyphae and necrotic keratin between the nail plate and nail bed)
- •on the target nail.
- •11. Presence of nail thickness exceeding 2 mm.
- •12. Patients with proximal subungual involvement (marker of
- •immunosuppressed patient).
- •13. Patients with severe plantar or moccasin tinea pedis (defined by
- •blistering, pustules or inability to ambulate).
- •14. Patients with nail abnormalities due to conditions like psoriasis,
- •lichen planus, immune dysfunction, collagen-vascular diseases,
- •peripheral vascular disease.
- •15. Patients with life expectancy less than 2 years.
- •16. Chemotherapy, immunosuppressive therapy in the 12 weeks prior
- •to Screening visit (V1).
- •17. Systemic corticosteroids, antimetabolites and immune-stimulants
- •therapy in the 4 weeks prior to Screening visit (V1).
- •18. HIV infection or any other immunodeficiency.
- •19. Alcohol or substance abuse.
- •20. Patients/parents (or legal guardian) unable to understand the
- •procedures and purposes of the study.
- •Exclusion criteria during the study:
- •Any topical product on nails is not allowed. Subjects with
- •cutaneous fungal infections who may require treatment during the
- •trial should be excluded or treated prior to enrolment.
- •Evidence of pregnancy will result in cessation of treatment and the
- •pregnancy outcome will be followed up until delivery.
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