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

Thea Pharma

Status: Not yet enrolling

Conditions: Eyelid; Wound

Treatments: Other: Cosmetic: Blephaderm

Study type: Observational

Funder types: Industry

Identifiers

NCT07234292

LT10100-001

Details and patient eligibility

About

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.

Enrollment: 30 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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).

Trial design

30 participants in 1 patient group

Group receiving Blephaderm

Treatment:

Other: Cosmetic: Blephaderm