Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 3:54 PM
Ignite Modification Date:
2025-12-24 @ 3:54 PM
NCT ID:
NCT07234292
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).
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT07234292
Study Brief:
Protocol Section:
NCT07234292