EUCTR2016-001242-25-DE进行中（未招募）1 期
An Early Phase Development, Partly Blinded, Positive and Vehicle Controlled, Randomized, Non-inferiority Investigation of the Pharmacokinetics, Safety and Efficacy of BB2603 Cutaneous Hand-Pump Spray versus Lamisil® Spray and versus BB2603 Vehicle Hand-Pump Spray in Subjects with Onychomycosis and associated Tinea Pedis.
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 46
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
入选标准
- •1. Males or females of 18 years old or older.
- •2. Clinical diagnosis of onychomycosis in at least one toenail with Onychomycosis Severity Index (OSI) 1-15 at Screening and Baseline (pre-dose D1) and PCR positive at screening.
- •3. Clinical diagnosis of TP with lesions localized to the interdigital spaces or predominantly interdigital, but may extend to other areas of the foot (the non-interdigital lesions should not be hyperkeratotic i.e. should not have the characteristics of tinea pedis moccasin), and confirmed by a positive potassium hydroxide (KOH) wet mount preparation Screening and Baseline (pre-dose D1).
- •4. Sum of the clinical signs and symptom scores of the target TP lesion is at least 2, including a minimum score of at least 1 for erythema AND a minimum score of 1 for either scaling or pruritus (on a scale of 0-3, where 1 indicated mild severity).
- •5. Non-menopausal or non-surgically sterilized childbearing potential female subjects must have a negative urine HCG at the time of entry into the study with no intentions of becoming pregnant during the study.
- •6. Non-menopausal or non-surgically sterilized childbearing potential female subjects must use a medically acceptable form of birth control.
- •7. Subjects must have the mental, literate, and legal ability to give a written informed consent, which must comply with the International Council for Harmonisation (ICH), guidelines and local requirements.
- •8. Non-menopausal or non-surgically sterilized childbearing potential female subjects must have a negative serum HCG at the time of entry into the study with no intentions of becoming pregnant during the study (See Study protocol section 6d).
- •9. Non-menopausal or non-surgically sterilized childbearing potential female subjects must use a medically acceptable form of birth control. Reliable contraception is defined as a method which results in a low failure rate, i.e., less than 1% per year when used consistently and correctly, such as implants, injectables, some intrauterine contraceptive devices (IUDs), complete sexual abstinence, or a vasectomised partner. Oral contraceptive medications are allowed in this study. Female subjects who are surgically sterile (bilateral tubal ligation, bilateral oophorectomy or hysterectomy) or postmenopausal (defined as no menstrual period within 1 year of screening) are also allowed to participate.
- •Subjects must have the mental, literate, and legal ability to give a written informed consent, which must comply with the International Council for Harmonisation (ICH) guidelines and local requirements.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 35
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 10
排除标准
- •1. PCR negative OM.
- •2. OSI =16.
- •3. KOH negative tinea pedis.
- •4. Known history of hypersensitivity or allergy to or known contraindication to the use of Lamisil® Spray, terbinafine, BB2603 or any of its components/excipients.
- •5. Pregnancy or planning to become pregnant during the study period.
- •6. Breast feeding.
- •7. Severe renal or hepatic impairment with parameters of Grade 3 or higher on the corresponding CTCAE scale.
- •8. Presence of other known clinically significant medical and/or psychological illnesses precluding participation.
- •9. Any dermatological condition that could mimic the signs and symptoms of TP or OM.
- •10. Progression of OM by >50% nail manifestation during the last 2 months before enrolment.
- •11. Use of any systemic (oral) or topical anti-fungal treatment for onychomycosis in the previous 3 months.
- •12. Use of systemic (oral) antipruritics, including antihistamines, within 72 hours prior to first dosing in the study (Day 1).
- •13. Use of systemic (oral or injectable) corticosteroid or antibiotic therapy within 1 month prior to first dosing in the study (Day 1).
- •14. Use of oral terbinafine or itraconazole (or other oral anti-fungal) within 3 months prior to first dosing in the study.
- •15. Use of topical corticosteroid, antibiotics or antifungal therapy for tinea pedis within 2 weeks prior to first dosing in the study.
- •16. Use of immunosuppressive medication or radiation therapy within 2 months prior to study entry.
- •17. Use of laser therapy, photodynamic therapy, chemical, surgical, relevant mechanical removal for onychomycosis within the last 3 months.
- •18. Confluent, diffuse moccasin-type tinea pedis associated of the entire plantar surface.
- •19. Presence of any other infection of the foot or other disease process that might confound the treatment evaluation.
- •20. History of dermatophyte infections unresponsive to systemic or topical antifungal drugs (other than onychomycosis).
- •21. Use of any investigational agent within 30 days or 5 halflives prior to randomization, whichever is longer.
- •22. Screening blood parameters >2 times upper limit of normal.
- •23. Unable or unwilling to complete the follow-up evaluations required for the study.
- •24. Any other condition that, in the opinion of the Investigator, would prevent the subject from effectively participating in the study, place the subject at risk or affect the assessment of efficacy and safety of the study medication.
- •25. Vulnerable subjects (such as those kept in detention).
- •26. Individuals involved in the planning and/or conduct of the study (i.e. Sponsor or employees of Sponsor, CRO employees and relatives thereof).
- •Any other condition that, in the opinion of the Investigator, would prevent the subject from effectively participating in the study, place the subject at risk or affect the assessment of efficacy and safety of the study medication.
- •Terbinafine resistance should be noted.
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