A Randomized Study to Evaluate the Efficacy of Herbal Ingredients Combined With a Carrier System (Phytonail) Compared With Amorolfine 5% Nail Lacquer (Loceryl) in the Treatment of Toenail Onychomycosis
试验速览
- 阶段
- 不适用
- 入组人数
- 72
- 试验地点
- 1
- 主要终点
- Mycological cure
研究概览
简要总结
Background: Onychomycosis, the most common nail disorder, is a superficial fungal infection affecting toenails more than fingernails. Onychomycosis can cause pain and discomfort and has the potential to be a source of morbidity. Although oral antifungal agents achieve a better complete cure rate for onychomycosis, many patients are worried about the side effects and unwilling to take oral medications. Phytonail is a mixture of herbal active ingredients including tea tree oil, lavender oil and Australian blue cypress oil with BioEqual carrier system. A preliminary trial has shown a 100% KOH negative rate in 32 nails after 12 weeks of Phytonail therapy. Amorolfine 5% nail lacquer (Loceryl) is a broad-spectrum morpholine antifungal demonstrated 60-75% mycological cure rate in several randomized controlled trials for the treatment of toenail onychomycosis.
Objective: To evaluate the efficacy and safety of Phytonail relative to amorolfine 5% nail lacquer in the treatment of toenail onychomycosis.
Methods: This is a randomized, parallel-group, open-labeled study in adult subjects with toenail onychomycosis. In this study, 60 eligible patients will be randomized in a 1: 1 ratio to one of the two treatment groups: Phytonail or amorolfine 5% nail lacquer. Before randomization, patients are to have onychomycosis in at least one great toenail with positive KOH examination and positive fungal culture. During the treatment phase, Phytonail will be applied twice daily and amorolfine 5% nail lacquer once weekly for 16 weeks to all affected toenails. Physician's assessments and photographic analyses will be carried out at baseline, Week 4, 8, 16, and 24. Mycological evaluation including KOH examination will be performed at baseline, Week 4, 8, and 16. Fungal culture will be performed at baseline and for KOH negative patients.
详细描述
Subjects aged 20-65 years with toenail onychomychosis involved at least one great toenail will be recruited in the study. Approximately 200 subjects will be screened, in order to randomize 72 eligible subjects. Allowing for approximately 20% drop-outs, it is estimated that for completing 60 eligible subjects, approximately 72 subjects would be enrolled. Subjects must meet all the inclusion criteria and none of the exclusion criteria to receive treatment assignment.
Procedures:
Explain study and obtain written informed consent: Screening Review inclusion/exclusion criteria including prior and concomitant medications: Screening and Baseline (Day 1) Demographics: Screening Medical history (including prior onychomycosis): Screening Personal and family history as well as history of any prior treatment for onychomycosis and any symptoms attributed to onychomycosis Physical examination: Screening Selection of target great toenail: Screening Proper nail trimming of target great toenail (as needed): all visits The subject's target great toenail will be properly trimmed as needed by the investigator or a qualified designee. Proper nail trimming is defined as cutting the nail plate to within 1 mm of the hyponychium or distal groove. In case of onycholysis the nail is to be trimmed not to the proximal limit of the onycholysis.
Percentage of nail involvement of the target great toenail based on signs of onychomycosis: all visits The percentage of involvement of the target great toenail will be determined by the investigator's visual estimate of the extent of the total nail area that shows signs of onychomycosis after proper trimming the nail.
Assessment of other toenails: all visits (except screening) At baseline (Day 1) and all subsequent visits, the investigator will identify all other toenails (excluding the target great toenail) with signs of onychomycosis and determine the total number of toenails that are completely clear (0% involvement) or almost clear (<10% involvement).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 20 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •The subject must meet ALL the criteria listed below both at Screening and Baseline (Day 1)
- •Subjects must be aged 20 to 65 years at Screening, and can be either sex.
- •Subjects must have onychomycosis, that (a) involves at least one great toenail (if two great toenails are infected, the one with greater involvement will be selected as target nail), and (b) has been mycologically confirmed at Screening Phase (positive potassium hydroxide (KOH) preparation and culture positive for dermatophytes, Candida spp., or molds).
- •Subjects must have the target great toenail capable of growing.
- •Subjects must be able to apply the study drugs to their toenails.
- •Subjects must be willing to sign the informed consent form and be able to adhere to dose and visit schedules during the study
- •Subjects must agree to use no other products including nail polish applied to the toenails during the study.
排除标准
- •The subject will not be selected for the study if ANY of the criteria listed below are met at Screening and/or Baseline (Day 1)
- •Subjects with a structural deformity of the target great toenail, including but not limited to genetic nail disorders, onychogryphosis, traumatic nail dystrophy, and/or any other abnormalities that in the investigator's judgment may interfere with efficacy assessments.
- •Subjects with a current or past history of psoriasis and /or lichen planus.
- •Subjects with a history of treatment failure (defined as no recognized increase in clean nail growth) after completion of ≧3 months of any oral antifungals.
- •Subjects have controlled diabetes with HbA1C≧8%.
- •Subjects with significant peripheral vascular disease or peripheral circulatory impairment, as evidenced by absence of dorsalis pedis or posterior tibial pulses.
- •Subject with a history of immunosuppression or presence of a serious concurrent medical condition that might adversely affect the evaluation of treatment response.
- •Subjects with chronic tinea pedis (eg, moccasin type) that in the investigator's judgment would require systemic treatment.
- •Subjects who have received any treatment listed below more recently than the indicated washout period or who must continue to receive such treatments Systemic antifungal treatments (24 weeks prior to Screening) Topical antifungal agents applied to the toenails, excluding antifungal agents for the treatment of tinea pedis (4 weeks prior to Screening) Investigational drugs (4 weeks prior to Screening) Oral or intramuscular corticosteroid or immunosuppressive agents (2 weeks prior to Day 1) Topical antifungal agents for the treatment of tinea pedis (prior to Day 1) Topical anti-inflammatory, topical corticosteroids, and topical immunosuppressive agents applied to the feet (2 weeks prior to Day 1)
- •Subject with a history of hypersensitivity to morpholine antifungal agents or essential herbal oil;
- •Women who are breast-feeding, pregnant, or intended to become pregnant; and
- •Subjects who are unable to comply with the treatment regimen.
- •Subjects who are participating in any other clinical study.
- •Subjects who are part of the staff personnel directly involved with the study.
研究组 & 干预措施
Phytonail
Phytonail is a mixture of herbal active ingredients including tea tree oil, lavender oil and Australian blue cypress (ABC) oil with BioEqual carrier system.
干预措施: Phytonail (Drug)
amorolfine 5% nail lacquer
5% amorolfine
干预措施: Loceryl (Drug)
结局指标
主要结局
Mycological cure
时间窗: At week 16
The primary efficacy endpoint of the study is the mycological cure rate of the target great toenail at Week 16. Mycological cure is defined as both negative KOH and negative fungal culture.
次要结局
- The treatment success rate of the target toenail(At Week16 and Week 24.)
- The complete cure rate of the target toenail(At Week 16 and Week 24)
- The CNG (clear nail growth) of the target great toenail(Week 16 and Week 24)