- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07234292
Evaluation of Patient Satisfaction With Blephaderm as a Complementary Care in Post-eyelid Surgery
Evaluation of Patient Satisfaction With a New Preservative-free Eyelid Cream as a Complementary Care in Post-eyelid Surgery: The ADMIRE Study
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.
Study Overview
Study Type
Enrollment (Estimated)
Contacts and Locations
Study Contact
- Name: Medical Affairs Director
- Phone Number: +33 4 73 98 14 36
- Email: florence.noirt@theapharma.com
Study Locations
-
-
-
Paris, France
- Recruiting
- Pierre-Vincent Jacomet Private Practice
-
Contact:
- Pierre-Vincent Jacomet, Dr.
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
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).
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
Group receiving 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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
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
|
3 months
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- LT10100-001
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Eyelid; Wound
-
University of California, San FranciscoCompletedSurgical Wound Infection | Surgical Site Infection | Eyelid Diseases | Skin Cancer Face | Surgical Incision | Antibiotic Side Effect | Antibiotic Allergy | Surgical Wound, Recent | Eyelid; WoundUnited States
-
Indonesia UniversityCompletedSurgical Incision | Ptosis, Eyelid | Blepharoptosis | Characteristics DiseaseIndonesia
-
Osheru Inc.RecruitingPtosis, Eyelid | Blepharoplasty | Dermatochalasis of Upper EyelidUnited States
-
University of EdinburghRoyal Free Hospital NHS Foundation Trust; National Health Service, United KingdomActive, not recruiting
-
University of California, San FranciscoCompletedAnesthesia, Local | Eyelid Tumor | Ophthalmology | Eyelid Bump | Eyelid Deformity | Eyelid Abscess | Eyelid Boil | Eyelid PapillomaUnited States
-
University of MiamiCompleted
-
Minia UniversityNot yet recruitingUpper Eyelid Dynamics
-
University of California, IrvineBeckman Laser Institute University of California IrvineCompleted
-
Montefiore Medical CenterRecruiting
-
Sheba Medical CenterUnknownEyelid Movement Disorders | Eyelid Ptosis CongenitalIsrael
Clinical Trials on Cosmetic: Blephaderm
-
Unilever R&DMS Clinical Research Pvt. LtdNot yet recruiting
-
Pierre Fabre Dermo CosmetiqueCompleted
-
SVR GroupCompletedAtopic DermatitisBelgium
-
Superior UniversityCompletedCosmetic Product Causing Toxic EffectPakistan
-
Johnson & Johnson Consumer Inc. (J&JCI)University of SheffieldTerminated
-
Pierre Fabre Dermo CosmetiqueCompleted
-
Avon Products, Inc.University of Cape Town, Groote Schuur HospitalNot yet recruitingAging Problems | Pigmentation
-
Zhenqi LuCompleted
-
Federico II UniversityCompleted
-
Medical University of WarsawCompletedTelogen Effluvium | Androgenetic Alopecia (AGA) | Female Pattern Hair Loss, Androgenic Alopecia