MULTICENTRIC, RANDOMIZED, EVALUATOR BLINDED CLINICAL INVESTIGATION FOR THE EVALUATION OF EFFICACY AND SAFETY OF TWO PRODUCTS FOR THE TREATMENT OF ONYCHOMYCOSIS
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 88
- 试验地点
- 1
- 主要终点
- Blinded evaluation of the percentage of healthy nail surface
研究概览
简要总结
The efficacy and safety of ENRICHED (X92001591) will be evaluated in a multicentric, randomized, evaluator blinded clinical investigation in 88 patients.
详细描述
Subjects will be treated with either the test medical device (ENRICHED X92001591) or the reference product (Loceryl, 5% amorolfine) for a period of 9 months. The primary objective of the investigation will be increase of % of healthy nail surface versus baseline, as evaluated by a blinded investigator. Subjects will be followed up for a period of 9 months, with visits at D0 (baseline), D90 (month 3), D180 (month 6) and D270 (month 9).
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
The primary objective is to evaluate the effectiveness of Enriched and Loceryl® in the treatment of onychomycosis based on the blinded evaluation of the percentage of healthy nail surface compared to baseline
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •1. Patient having given freely her/his informed, written consent.
- •Patient having a good general health.
- •Age: between 18 and 70 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).
- •5. 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.
- •7. Patient being psychologically able to understand information and to give their/his/her consent.
- •8. Patient having stopped any systemic antifungal treatment since at least 6 months before screening and/or any topical antifungal treatment since at least 3 months before screening.
- •9. Patient who agree 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.
- •10. 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.
- •7. Patient with cutaneous pathology on studied zone (other than onychomycosis like angioma, dermatitis…).
研究组 & 干预措施
Enriched
To be used twice daily during 9 month
干预措施: Enriched (Device)
Loceryl
To be used 1 per week during 9 months
干预措施: Loceryl 5% (Drug)
结局指标
主要结局
Blinded evaluation of the percentage of healthy nail surface
时间窗: 270 days
Variation of the percentage of healthy surface after 270 days (9 months) of treatment with the test medical device or reference product versus baseline value. Blinded evaluation is done by digital analysis of photographs of the infected toenail or fingernail.
次要结局
- Percentage of healthy surface (performance)(90 days, 180 days)
- Mirobiological efficacy ; KOH staining (Performance)(270 days)
- Clinical efficacy: Visual appearance of nail (including onycholysis, nail dystrophy, nail discoloration and nail thickening) (Performance)(90 days, 180 days, 270 days)
- Clinical efficacy: onychomycosis evolution (Performance)(90 days, 180 days, 270 days)
- Impact on quality of life (Performance)(180 days, 270 days)
- Subjective evaluation questionnaire for the patient (Performance)(14 days, 90 days, 180 days, 270 days)
- Evaluation of tolerance(90 days, 180 days, 270 days)