PERFORMANCE AND SAFETY OF THE MEDICAL DEVICE "URGO ONGLES ABIMES PAR MYCOSES ET TRAUMATISMES" IN THE TREATMENT OF MILD TO MODERATE DISTAL ONYCHOMYCOSIS: AN OPEN STUDY (MICKAEL)
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 54
- 试验地点
- 1
- 主要终点
- Mycological cure rate evaluated at 6 months
研究概览
简要总结
The objective of this clinical study is to evaluate the performance of URGO MICKAEL Filmogel as a topical treatment for mild to moderate onychomycosis
详细描述
Patients with a positive dermatophyte/fungal culture from a toenail sample are eligible for inclusion in the study. Patients apply the device under investigation daily to the affected toenails.
Patients are followed for up to 6 months, or until a negative fungal culture is obtained and the clinical appearance of the treated nails indicates resolution and significant improvement of the onychomycosis.
Four visits will be organized at the investigation site under the supervision of the principal investigator:
- Baseline / Inclusion visit (V0)
- 3 follow-up visits (V1, V2 and final V3) carried out 1, 3 and 6 months after the initiation of the treatment.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •With 1 or 2 big toenail(s) damaged, which the clinical appearance of at least one great toenail is suggestive of onychomycosis.
- •Big toenails with distal mild to moderate subungual onychomycosis (OSI Score < 16, no proximal or lunula involvement, and ≤50% nail involvement).
- •Able to understand and comply with protocol requirements and instructions, including applying the device.
- •Affiliated to a French Health insurance scheme.
- •Having signed an informed consent.
- •8. With 1 or 2 big toenail(s) damaged by onychomycosis confirmed by positive culture for dermatophytes / fungi on at least one big toenail.
排除标准
- •Having a known allergy or hypersensitivity or contraindication to one of the constituents of UOA.
- •The toenail(s) to be included in the study present(s) severe onychomycosis (which should be treated by systemic drug), or is/are unstructured, has/have severe microcracking or severe onycholysis, or the nail(s) or nail(s) contour has/have severe lesions.
- •Having used any systemic antifungal treatment in the last 6 months before Baseline/pre-inclusion visit V
- •Having used any topical antifungal treatment in the last 3 months before Baseline/pre-inclusion visit V
- •With cutaneous pathology on studied zone (onychogryphosis, congenital ungual deformation, toe deformation or of the foot, hallux valgus, hallux rigidus, hallux extensus, toe claws or other pathologies than onychomycosis like angioma, dermatitis…).
- •With a condition or receiving medication which, according to the investigator's judgment, could jeopardize the safety of the subject.
- •Suffering from serious or progressive diseases (to investigator's discretion) such as uncontrolled diabetes, peripheral circulatory disease, lichen planus, immunosuppressive pathology, chronic venous insufficiency, Peripheral Arterial Obstructive Disease, delay, or lack of ungual growth etc.
- •May not respect the constraints imposed by the protocol.
- •Enrolled in another clinical trial or being in a period of exclusion from a previous clinical trial.
- •Woman of childbearing age (except menopausal, hysterectomised, sterilized) not using effective contraception (oral contraceptives, intra-uterine device, contraceptive implant, or condoms).
- •Person belonging to a population referred to in articles 64 (incapacitated subjects), 65 (minors), 66 (pregnant or breastfeeding women), 67 (persons performing mandatory military service, persons deprived of liberty, persons who, due to a judicial decision) and 68 (patients in emergency) of the MDR.
研究组 & 干预措施
URGO MICKAEL Filmogel
Local treatment of big toenails with positive culture
干预措施: URGO MICKAEL Filmogel (Device)
结局指标
主要结局
Mycological cure rate evaluated at 6 months
时间窗: 180 days
Mycological cure is defined by a negative culture for dermatophytes/fungi from the big toenail under study. A direct microscopic examination is performed after dissolving and staining the toenail sample using MYCETCOLOR® (Mycol60). The potassium hydroxide (KOH) test indicates the presence or absence of fungal elements. However, it does not provide information on the viability or etiology of any fungal elements detected. Therefore, the samples are also placed on a suitable culture medium and incubated at a controlled temperature for several days to several weeks. Fungal growth is monitored, and any colonies that appear are identified microscopically to determine the specific fungal species involved.
次要结局
- Mycological cure rate evaluated at 1 month(30 days)
- Mycological cure rate evaluated at 3 months(90 days)
- Change from baseline in onychomycosis severity at 1 month(30 days)
- Change from baseline in onychomycosis severity at 3 months(90 days)
- Change from baseline in onychomycosis severity at 6 months(180 days)
- Change from baseline in toenail condition at 1 month(30 days)
- Change from baseline in toenail condition at 3 months(90 days)
- Change from baseline in toenail condition at 6 months(180 days)
- Clear toenail area in toenail with negative culture at 6 months(180 days)
- Investigator's opinion on treatment efficacy at 1 month(30 days)
- Investigator's opinion on treatment efficacy at 3 months(90 days)
- Investigator's opinion on treatment efficacy at 6 months(180 days)
- Investigator's opinion on toenail appearance at 1 month(30 days)
- Investigator's opinion on toenail appearance at 3 months(90 days)
- Investigator's opinion on toenail appearance at 6 months(180 days)
- Patient's satisfaction with the treatment effectiveness at 1 month(30 days)
- Patient's satisfaction with the treatment effectiveness at 3 months(90 days)
- Patient's satisfaction with the treatment effectiveness at 6 months(180 days)