Open Clinical Investigation to Evaluate Efficacy And Safety of the Medical Device "Apaisant Serum - Ingrown Nails" in The Treatment of Ingrown Nail
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 22
- 试验地点
- 2
- 主要终点
- Change in pain severity of the ingrown toenail
研究概览
简要总结
To open-label clinical study aims to evaluate the efficacy and safety of APAISANT SERUM - INGROWN NAILS, a Class IIa CE-marked medical device, in relieving pain and discomfort associated with inflamed ingrown nails. The study includes 22 subjects with ingrown nails at stage 1 or 2, who will apply the product twice daily for 7 days. The primary objective is to assess the reduction of pain using a Numerical Rating Scale (NRS, 0-10). Secondary objectives include assessing discomfort, inflammation, and overall symptom improvement. The study also evaluates investigator and patient global assessments, tolerance, and acceptability of the product. Safety will be monitored through clinical assessments and the collection of adverse events.
详细描述
This open-label, before-and-after study aims to assess the efficacy and tolerance of APAISANT SERUM - INGROWN NAILS in relieving pain, discomfort, and inflammation associated with ingrown toenails (stage 1 and 2). The study will include 22 subjects, ensuring a minimum of 20 analyzable cases. Participants will apply the product twice daily for 7 days at home.
Primary Objective:
To evaluate the reduction in pain at Day 7 (Visit 2) compared to baseline (Day 0), using a 0-10 Numerical Rating Scale (NRS).
Secondary Objectives:
To assess the reduction of discomfort at Day 7. To evaluate improvement in clinical symptoms (redness, edema, inflammation) and subjective symptoms (pain while touching, irritation).
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
- 3 Years 至 —（Child, 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.
- •Male or female more than 3 years old.
- •Minor whose legally designated representative have given their free and express informed consent.
- •Subject affiliated to a health social security system.
- •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 the study end.
- •Subjects presenting an inflamed Ingrown nails (folds) and with pain ;.
- •state 1 : inlaid nail OR
- •state 2 : peri inguale inflammation
排除标准
- •Subject presenting state 3 or 4 of the ingrown nails (presenting wounds, bleeding, discharge, granulation tissue growth).
- •Subject who is currently participating, in another clinical study liable to interfere with the study assessments according to the investigator's assessment
- •Subject unable to understand the information given including study procedures (for linguistic or psychiatric reasons) and to give his/her consent in writing or to report required information in writing in his/her diary
- •Subject who, in the judgement of the investigator, is not likely to be compliant with study-related constraints and requirements
- •Subject who has forfeited his/her freedom by administrative or legal award or is under guardianship
- •For woman of childbearing potential: pregnant or breastfeeding or planning to get pregnant during the study
- •Subject having a skin disease, skin abnormalities, or dermatological condition on the studied area liable to interfere with the study assessments
- •Subject with a known history of allergy or contact dermatitis caused by any of the ingredients of the tested product
- •Acute, chronic or progressive disease or medical history considered by the investigator hazardous for the subject or incompatible with the study or liable to interfere with the study assessments
- •Any systemic treatment incompatible with the study or liable to interfere with the study assessments according to the investigator, in the weeks prior to the inclusion visit, ongoing or planned to be started during the study
- •Any topical treatment on the tested area incompatible with the study or liable to interfere with the study assessments according to the investigator, in the weeks prior to the inclusion visit, ongoing or planned to be started during the study.
结局指标
主要结局
Change in pain severity of the ingrown toenail
时间窗: Day 7 (D7) compared to baseline (D0)
Pain severity will be assessed using the Numerical Rating Scale (NRS), ranging from 0 (no pain) to 10 (worst possible pain). Higher scores indicate a worse outcome. The primary objective is to determine the effectiveness of Apaisant Serum - Ingrown Nails in reducing pain after 7 days of treatment.
次要结局
- Change in discomfort severity of the ingrown toenail(Day 7 (D7) compared to baseline (D0))
- Improvement in ingrown nail symptom - redness(Day 7 (D7) compared to baseline (D0))
- Improvement in ingrown nail symptom - edema(Day 7 (D7) compared to baseline (D0))
- Improvement in ingrown nail symptoms - inflammation(Day 7 (D7) compared to baseline (D0))
- Improvement in ingrown nail symptoms - pain touch(Day 7 (D7) compared to baseline (D0))
- Improvement in ingrown nail symptoms - irritation(Day 7 (D7) compared to baseline (D0))
- Improvement in ingrown nail symptoms - overall appearance of the nails(Day 7 (D7) compared to baseline (D0))
- Improvement in ingrown nail symptoms - gloss appearance of the nail(Day 7 (D7) compared to baseline (D0))
- Improvement in ingrown nail symptoms - nail smoothness(Day 7 (D7) compared to baseline (D0))
- Improvement in ingrown nail symptoms - the softness of the nail and its contour(Day 7 (D7) compared to baseline (D0))
- Improvement in ingrown nail symptoms - nail nourishment(Day 7 (D7) compared to baseline (D0))
- Change in pain over time(From Day 1 (D1) to Day 7 (D7) compared to baseline (D0))
- Change in discomfort over time(From Day 1 (D1) to Day 7 (D7) compared to baseline (D0))
- Investigator Global Assessment (IGA) Score(Day 7 (D7))
- Patient Global Assessment (PGA) Score(Day 7 (D7))
- Subjective evaluation of general appreciation of the product(Day 7 (D7))
- Subjective evaluation of efficacy(Day 7 (D7))
- Subjective evaluation of future use of the product(Day 7 (D7))
- Tolerance and safety assessment(Throughout the study (D0-D7))
- Illustrative macrophotographs(Day 0 (D0) and Day 7 (D7))