Идёт набор NCT07234292

Evaluation of Patient Satisfaction With Blephaderm as a Complementary Care in Post-eyelid Surgery

— Наблюдательное Eyelid; Wound

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают: В протоколе указаны: Cosmetic: Blephaderm.
Кому может быть актуально: Состояния в реестре: Eyelid; Wound. Базовые параметры: от 18 лет · Все.
Что важно проверить: Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится: Франция
Следующий шаг: Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →

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Официальное название

Evaluation of Patient Satisfaction With a New Preservative-free Eyelid Cream as a Complementary Care in Post-eyelid Surgery: The ADMIRE Study

Обзор

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.

Вмешательства

Другое Cosmetic: Blephaderm
Preservative free eyelid cream: Aqua (water), oleyl erucate, trehalose, sodium acrylates copolymer, lecithin, Ophiopogon japonicus root extract, hydrolyzed hyaluronic acid, maltodextrin, tocopherol, sodium hydroxide, phytic acid, Glycine soja (soybean) oil, Helianthus annuus seed oil.

Первичные конечные точки

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). [Срок оценки: 3 months]

Критерии участия

Критерии включения

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.

Критерии исключения

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