NCT07234292招募中不适用
Evaluation of Patient Satisfaction With a New Preservative-free Eyelid Cream as a Complementary Care in Post-eyelid Surgery: The ADMIRE Study
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 30
- 试验地点
- 2
- 主要终点
- global satisfaction of the patient on eyelid comfort after 3 months of Bllephaderm® use, assessed at M4, using a VAS from 0 (unsatisfied) to 10 (very satisfied).
研究概览
简要总结
The goal of this non-interventional, open and monocentric study is to evaluate the satisfaction of 30 patients, after 3 months with Blephaderm eyelid cream, as a complementary care in post-eyelid surgery (Blepharopasty or ptosis).
The participant will be asked to use Blephaderm twice a day. The patient satisfaction will be evaluated using a VAS scale.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
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
- •Age ≥ 18 years old
- •Patients planning a blepharoplasty or a ptosis surgery in at least one eye.
- •Patient affiliated to a health social security system
- •Female of childbearing potential should use a medically accepted contraceptive regimen since at least 12 weeks before the beginning of the study, during all the study and at least 1 month after the study end.
排除标准
- •In terms of population:
- •Pregnant or nursing woman or planning a pregnancy during the study.
- •Patient who had been deprived of their freedom by administrative or legal decision
- •Minor patient.
- •Major patient who is under guardianship or who is not able to express his non opposition.
- •Patient suspected to be non-compliant according to the investigator's judgment.
- •Patient enrolled in another clinical trial or which exclusion period is not over.
- •In terms of associated pathology
- •Patient with a history or active systemic 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.
- •Patient with known or suspected hypersensitivity to one of the components of the product.
- •Related to previous or ongoing treatment
- •Patient undergoing a topical treatment on the test area or a systemic treatment.
- •Patient under a long-term corticosteroid, NSAID or HIV therapy at the investigator appreciation.
- •Patient under immunosuppressive therapy
- •Patient under bisphosphonate therapy
- •Patient having Type 1 diabetes
- •Patient having atopic or eczema skin
- •In terms of lifestyle
- •Intensive exposure to sunlight or UV-rays foreseen during the study.
- •Patient planning to change her/his life habits during the study.
- •Patient with an excessive consumption of alcohol and/or tobacco defined as:
- •an excessive consumption of alcohol: Drinking more than
- •4 units a day for adult men and more than 2 units a day for adult women,
- •an excessive consumption of tobacco: ≥15-20 Cigarettes Per Day (CPD).
研究组 & 干预措施
Group receiving Blephaderm
干预措施: Cosmetic: Blephaderm (Other)
结局指标
主要结局
global satisfaction of the patient on eyelid comfort after 3 months of Bllephaderm® use, assessed at M4, using a VAS from 0 (unsatisfied) to 10 (very satisfied).
时间窗: 3 months
次要结局
未报告次要终点
研究者
研究点 (2)
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