NCT06254027尚未招募不适用
Multicentric, Randomized, Evaluator Blinded Clinical Investigation for the Evaluation of Efficacy and Safety of Two Medical Devices for the Treatment of Onychomycosis
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 132
- 主要终点
- Percentage of healthy surface (Performance)
研究概览
简要总结
The goal of this clinical trial is to evaluate the effectiveness of FORTE, ACTIVE COVER LIGHT and Loceryl® in the treatment of onychomycosis based on the blinded evaluation of the percentage of healthy nail surface compared to baseline.
详细描述
The primary objective of the study is to evaluate the effectiveness of FORTE (X92001873), ACTIVE COVER LIGHT (X92001872) and Loceryl® in the treatment of onychomycosis based on the blinded evaluation of the percentage of healthy nail surface compared to baseline.
The secondary objectives are to evaluate:
- Their effectiveness in the treatment of onychomycosis based on the microbiological cure (KOH staining and fungal culture)
- Their effectiveness in the improvement of nail appearance (onychomycosis evolution, onycholysis, dystrophy, discoloration, and nail thickening)
- Their effectiveness in the improvement of the quality of life of the patients using a specific questionnaire.
- Their effectiveness, tolerance and acceptability based on patient's opinion.
- Their safety The aim of the study is to demonstrate non-inferiority of the change in healthy nail surface from baseline to D270 of each product (μD) versus a predefined limit of 16% (clinically meaningful: μC) with a non-inferiority margin of δ = -5%
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
- Single (Outcomes Assessor)
盲法说明
Blinded evaluation is done by digital analysis of photographs of the infected toenail or fingernail.
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Patient having given freely her/his informed, written consent.
- •Patient having a good general health.
- •Age: more than 18 years.
- •Patient with superficial onychomycosis on at least one great toenail or fingernail (for at least 10% in each arm) or light to moderate disto-lateral onychomycosis (without matrix involvement and involvement <2/3 of the tablets).
- •Patient with positive KOH staining.
- •Patient cooperative and aware of the products modalities of use and the necessity and duration of the controls so that perfect adhesion to the protocol can be expected.
- •Patient being psychologically able to understand information and to give their/his/her consent.
- •Patient having stopped any systemic antifungal treatment since at least 6 months before screening.
- •Patient having stopped any topical antifungal treatment since at least 3 months before screening.
- •Patient who agrees to refrain from receiving pedicure/manicure, artificial nails and/or cosmetic nail varnish or other medication on the nail being treated for the entire study duration.
- •Female of childbearing potential should use a contraceptive regimen recognized as effective since at least 12 weeks before screening visit, during all the study and at least 1 month after study end.
排除标准
- •Pregnant, breastfeeding woman or woman planning a pregnancy during the study.
- •Patient considered by the investigator likely to be non-compliant with the protocol.
- •Patient enrolled in another clinical trial or which exclusion period is not over.
- •Patient with a condition or receiving a medication which, in the investigator's judgment, put the patient at undue risk.
- •Patient suffering from a severe or progressive disease (to investigator's discretion) such as uncontrolled diabetes, peripheral circulatory disease, HIV, psoriasis, lichen planus, immunosuppressive pathology...
- •Patient having a known allergy or hypersensitivity to one of the constituents of the tested products.
- •Patient with cutaneous pathology on studied zone (other than onychomycosis like angioma, dermatitis...).
研究组 & 干预措施
Forte
Experimental
Device:
One application per day for 9 months.
干预措施: Forte (Device)
Active Cover Light
Experimental
Device:
One application per day for 9 months.
干预措施: Active Cover Light (Device)
Loceryl 5%
Active Comparator
Drug: Loceryl 5% One application per week for 3 months
干预措施: Loceryl (Drug)
结局指标
主要结局
Percentage of healthy surface (Performance)
时间窗: 270 days
Variation of the percentage of healthy surface after 270 days (9 months) of treatment with the test medical devices (FORTE or ACTIVE COVER LIGHT) or reference product (Loceryl) versus baseline value.
次要结局
- Clinical efficacy: onychomycosis evolution (Performance)(30 days; 90 days; 180 days; 270 days)
- Evaluation of tolerance(30 days; 90 days; 180 days; 270 days)
- Subjective evaluation questionnaire for the patient (Performance)(14 days; 30 days; 90 days; 180 days; 270 days)
- Percentage of healthy surface (Performance)(30 days; 90 days; 180 days)
- Microbiological efficacy: KOH staining (Performance)(270 days (month 9))
- Clinical efficacy: Visual appearance of nail (including onycholysis, nail dystrophy, nail discoloration and nail thickening) (Performance)(Baseline, 30 days; 90 days, 180 days; 270 days)
- Impact on quality of life (Performance)(Baseline, 30 days; 90 days, 180 days; 270 days)
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