Clinical Evaluation of Efficacy and Safety of a Medical Device for the Treatment of Toenail Onychomycosis
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 76
- 试验地点
- 1
- 主要终点
- Percentage of healthy surface (performance)
研究概览
简要总结
The efficacy and safety of Solver Pen (prototype number X92001704) is evaluated in this randomized, open label, controlled, investigator-blinded, comparative clinical trial in 76 patients. Subjects are treated with either the test medical device (Solver Pen) or the comparator (Loceryl, 5% amorolfine), respectively, for a period of 90 days. The primary objective of the investigation is the increase of percentage of healthy surface on the great toenail at study end versus baseline, as evaluated by a blinded investigator. Patients are followed up for a period of 90 days, with visits at D0 (baseline), D30, D60 and D90, respectively.
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)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patient having given her/his informed, written consent.
- •Patient cooperative and aware of the 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.
- •Age: more than 18 years.
- •Subject with superficial onychomycosis on at least one great toenail or light to moderate disto-lateral onychomycosis (without matrix involvement and involvement <2/3 of the tablet).
- •Patient with positive KOH staining.
- •Patient having stopped any systemic antifungal treatment since at least 6 months before inclusion and/or any topical antifungal treatment since at least 3 months before inclusion.
- •Women of childbearing potential should use an accepted contraceptive regimen since at least 12 weeks before the beginning of the study, during all the study and at least 1 month after study end.
排除标准
- •Pregnant or nursing woman or planning a pregnancy during the investigation;
- •Patient considered by the Investigator likely to be non-compliant with the protocol.
- •Patient enrolled in another clinical trial during the test period.
- •Subject having a known allergy to one of the constituents of the tested products.
- •Patient with a condition or receiving a medication which, in the investigator's judgment, put the subject at undue risk;
- •Patient suffering from serious or progressive diseases (to investigator's discretion) such as uncontrolled diabetes, peripheral circulatory disease, HIV, psoriasis, lichen planus, immunosuppressive pathology...
- •Subject with cutaneous pathology on studied zone (other than onychomycosis like angioma, dermatitis...).
研究组 & 干预措施
Loceryl 5%
干预措施: Loceryl 5% (Drug)
Solver Pen
干预措施: Solver Pen (Device)
结局指标
主要结局
Percentage of healthy surface (performance)
时间窗: 90 days
Variation of the percentage of healthy surface after 90 days of treatment with the test medical device or reference versus baseline value. Evaluation is done in blind by digital analysis of photographs of the great, infected toenail.
次要结局
- Microbiological efficacy: fungal culture (performance)(90 days)
- Clinical efficacy: nail discoloration (performance)(30, 60 and 90 days)
- Percentage of healthy surface (performance)(30 and 60 days)
- Microbiological efficacy: KOH staining (performance)(90 days)
- Clinical efficacy: onychomycosis evolution (performance)(30, 60 and 90 days)
- Clinical efficacy: nail distrophy (performance)(30, 60 and 90 days)
- Subjective evaluation questionnaire for the patient (performance)(14, 30, 60 and 90 days of treatment)
- Assessment of local tolerance by the investigator (safety and tolerability)(30, 60 and 90 days)
- Clinical efficacy: onycholysis (performance)(30, 60 and 90 days)
- Incidence of Adverse events (safety and tolerability)(30, 60 and 90 days)
- Clinical efficacy: nail thickening (performance)(30, 60 and 90 days)
- Impact on quality of life (performance)(60 and 90 days)