Evaluation of Patient Satisfaction With Blephaderm as a Complementary Care in Post-eyelid Surgery
Recruiting
Observational Study
Eyelid; Wound
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
No Study Drug
Researchers observe your health over time — no experimental treatment is given.
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Review the details below, then apply to join this clinical trial.
At a Glance
Age
18 and older
Sex
Any
Study type
Observational
Participants needed
30 (estimated)
Sponsor
Laboratoires Thea · Industry
Who this trial is looking for
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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.
Trial Locations
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Status
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 …
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).
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