Ignite Creation Date:
2025-12-24 @ 3:54 PM
Ignite Modification Date:
2025-12-25 @ 1:59 PM
Study NCT ID:
NCT07234292
Status:
NOT_YET_RECRUITING
Last Update Posted:
2025-11-18
First Post:
2025-11-14
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Evaluation of Patient Satisfaction With Blephaderm as a Complementary Care in Post-eyelid Surgery.
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D014947', 'term': 'Wounds and Injuries'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 30}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2025-11-15', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-11', 'completionDateStruct': {'date': '2026-05-15', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-11-14', 'studyFirstSubmitDate': '2025-11-14', 'studyFirstSubmitQcDate': '2025-11-14', 'lastUpdatePostDateStruct': {'date': '2025-11-18', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2025-11-18', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2026-05-15', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': '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).', 'timeFrame': '3 months'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Eyelid; Wound']}, 'descriptionModule': {'briefSummary': '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).\n\nThe participant will be asked to use Blephaderm twice a day. The patient satisfaction will be evaluated using a VAS scale.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'A total of 30 patients undergoing blepharoplasty or ptosis surgery', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Age ≥ 18 years old\n* Patients planning a blepharoplasty or a ptosis surgery in at least one eye.\n* Patient affiliated to a health social security system\n* 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.\n\nExclusion Criteria:\n\nIn terms of population:\n\n* Pregnant or nursing woman or planning a pregnancy during the study.\n* Patient who had been deprived of their freedom by administrative or legal decision\n* Minor patient.\n* Major patient who is under guardianship or who is not able to express his non opposition.\n* Patient suspected to be non-compliant according to the investigator's judgment.\n* Patient enrolled in another clinical trial or which exclusion period is not over.\n\nIn terms of associated pathology\n\n* Patient with a history or active systemic condition or receiving a medication which, in the investigator's judgment, put the patient at undue risk.\n* Patient suffering from a severe or progressive disease.\n* Patient with known or suspected hypersensitivity to one of the components of the product.\n\nRelated to previous or ongoing treatment\n\n* Patient undergoing a topical treatment on the test area or a systemic treatment.\n* Patient under a long-term corticosteroid, NSAID or HIV therapy at the investigator appreciation.\n* Patient under immunosuppressive therapy\n* Patient under bisphosphonate therapy\n* Patient having Type 1 diabetes\n* Patient having atopic or eczema skin\n\nIn terms of lifestyle\n\n* Intensive exposure to sunlight or UV-rays foreseen during the study.\n* Patient planning to change her/his life habits during the study.\n* Patient with an excessive consumption of alcohol and/or tobacco defined as:\n* an excessive consumption of alcohol: Drinking more than\n* 4 units a day for adult men and more than 2 units a day for adult women,\n* an excessive consumption of tobacco: ≥15-20 Cigarettes Per Day (CPD)."}, 'identificationModule': {'nctId': 'NCT07234292', 'briefTitle': 'Evaluation of Patient Satisfaction With Blephaderm as a Complementary Care in Post-eyelid Surgery.', 'organization': {'class': 'INDUSTRY', 'fullName': 'Laboratoires Thea'}, 'officialTitle': 'Evaluation of Patient Satisfaction With a New Preservative-free Eyelid Cream as a Complementary Care in Post-eyelid Surgery: The ADMIRE Study', 'orgStudyIdInfo': {'id': 'LT10100-001'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Group receiving Blephaderm', 'interventionNames': ['Other: Cosmetic: Blephaderm']}], 'interventions': [{'name': 'Cosmetic: Blephaderm', 'type': 'OTHER', 'description': '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.', 'armGroupLabels': ['Group receiving Blephaderm']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Paris', 'country': 'France', 'contacts': [{'name': 'Pierre-Vincent Jacomet, Dr.', 'role': 'CONTACT'}], 'facility': 'Pierre-Vincent Jacomet Private Practice', 'geoPoint': {'lat': 48.85341, 'lon': 2.3488}}], 'centralContacts': [{'name': 'Medical Affairs Director', 'role': 'CONTACT', 'email': 'florence.noirt@theapharma.com', 'phone': '+33 4 73 98 14 36'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Laboratoires Thea', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}