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

Official title

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

Overview

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.

Interventions

• Other 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.

Primary outcome measures

• 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). [Time frame: 3 months]

Eligibility criteria

Inclusion criteria

• 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.

Exclusion criteria

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).

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model

Cohort

Study locations

France · 1 center

• Pierre-Vincent Jacomet Private Practice — Paris

Identifiers

NCT: NCT07234292 · LT10100-001

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗