Patient satisfaction with Blephaderm as complementary care after eyelid surgery.

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

This test looks at whether using Blephaderm eyelid cream twice daily for three months after blepharoplasty or ptosis surgery improves satisfaction for adult patients.

Quick facts

• Study type: Observational
• Enrollment: 30 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Laboratoires Thea (industry)
• Locations: 1 site (Paris)
• Trial ID: NCT07234292 on ClinicalTrials.gov

What this trial studies

This is a non-interventional, open-label, single-center observation of 30 adult patients undergoing blepharoplasty or ptosis surgery who will apply Blephaderm twice daily. Patient satisfaction will be measured with a visual analog scale (VAS) at three months postoperatively. The protocol is monocentric and sponsored by Laboratoires Théa at a private practice in Paris. The design focuses on real-world complementary cosmetic care rather than a randomized comparison.

Who should consider this trial

Good fit: Adults aged 18 or older planning blepharoplasty or ptosis surgery who are affiliated with a health social security system and able to follow twice-daily topical application are ideal candidates.

Not a fit: Patients who are pregnant or nursing, minors, under guardianship, non-compliant, enrolled in another trial, or with active systemic conditions/medications that affect healing may not benefit or be eligible.

Why it matters

Potential benefit: If successful, Blephaderm could increase comfort and cosmetic satisfaction during recovery after eyelid surgery.

How similar studies have performed: Topical eyelid products are commonly used after eyelid procedures and some small observational reports suggest symptomatic or cosmetic benefit, but high-quality controlled evidence is limited.

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).

Where this trial is running

Paris

• Pierre-Vincent Jacomet Private Practice — Paris, France (RECRUITING)

Study contacts

• Study coordinator: Medical Affairs Director

Conditions: Eyelid, Wound