Ignite Creation Date:
2025-12-24 @ 12:51 PM
Ignite Modification Date:
2026-01-03 @ 7:53 PM
Study NCT ID:
NCT07255261
Status:
RECRUITING
Last Update Posted:
2025-12-08
First Post:
2025-11-14
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Evaluation of Facial HA Dermal Fillers in Real-Life Conditions
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 460}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2025-07-02', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-12', 'completionDateStruct': {'date': '2028-07', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-12-01', 'studyFirstSubmitDate': '2025-11-14', 'studyFirstSubmitQcDate': '2025-11-19', 'lastUpdatePostDateStruct': {'date': '2025-12-08', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2025-12-01', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2028-07', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': "Number of patients returning to their baseline (pre-injection) state for each treated area, based on the investigator's assessment using 5- or 6-point area-specific scales.", 'timeFrame': 'At each follow-up visit (6 months, 12 months, 18 months and 24 months)'}], 'secondaryOutcomes': [{'measure': 'Injection site reactions (ISR) assessed by the investigators.', 'timeFrame': 'D0 (post-first injection), M1 (post optional touch-up), M12/M18 (post optional retreatment)'}, {'measure': 'Number of adverse device effects (ADEs) and serious adverse device effects (SADEs) assessed by the investigators.', 'timeFrame': 'From the injection (day 0) to the end of the follow-up period (24 months).'}, {'measure': 'Subject-assessed aesthetic improvement of each treated area, measured using the Global Aesthetic Improvement Scale (GAIS), a 5-point scale ranging from "worse" to "very much improved.', 'timeFrame': 'At each visit (Day 0 after injection, day 30 (if any visit), 6 months, 12 months, 18 months and 24 months)'}, {'measure': 'Investigator-assessed aesthetic improvement of each treated area, measured using the Global Aesthetic Improvement Scale (GAIS), a 5-point scale ranging from "worse" to "very much improved.', 'timeFrame': 'At each visit (Day 0 after injection, day 30 (if any visit), 6 months, 12 months, 18 months and 24 months)'}, {'measure': 'Investigator-assessed wrinkle severity or volume using 5- or 6-point area-specific scales for each treated area.', 'timeFrame': 'At each visit (Day 0 before and after injection, at 30 Days (if any visit), 6 months, 12 months, 18 months, and 24 months)'}, {'measure': 'Subject-reported pain per treated area, rated on an 11-point scale (0 = no pain, 10 = worst pain).', 'timeFrame': 'During the initial injection procedure at day 0'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Lips Enhancement', 'Perioral Wrinkles', 'Nasolabial Fold Wrinkles', 'Cheek Augmentation', 'Infraorbital Hollows']}, 'descriptionModule': {'briefSummary': 'The goal of this post-market interventional study is to confirm, under real-life conditions, the safety and performance of hyaluronic acid-based dermal fillers intended to modify skin anatomy and facial appearance. Subjects aged 18 years or older seeking aesthetic treatment of the lips, perioral lines, nasolabial folds, cheeks, and/or infraorbital hollows may be included. The main question the study aims to answer is: How long does the effect of the products last?\n\nParticipants will attend follow-up visits every 6 months after the initial injection, until the end of follow-up at 24 months. During each visit, the investigator will assess performance and safety through a simple clinical examination. At each follow-up visit, subjects will also evaluate the aesthetic improvement compared with their pre-injection appearance. Subjects will be asked about the level of pain experienced during the initial injection.\n\nIf the subject wishes, a retreatment may be performed at the 12-month or 18-month follow-up visit, provided that the treated area(s) have returned to the pre-injection state.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Subject seeking an aesthetic correction of the infraorbital hollows with FASY P and/ or an aesthetic correction of the lips with ESTYME® LIPS, and/ or an aesthetic correction of the perioral lines with ESTYME® SMOOTH, and/ or an aesthetic correction of nasolabial folds with ESTYME® SMOOTH, and/ or an aesthetic correction of cheeks with ESTYME® SCULPT.\n* Subject who agreed to participate and have signed an informed consent.\n* Age: over 18 years old.\n* Subject being affiliated to a health social security system.\n\nExclusion Criteria:\n\n* Minors\n* Subjects with a known allergy to hyaluronic acid, lidocaine or amide local anesthetics.\n* Subjects with porphyria.\n* Subjects with an autoimmune disorder, or using an immunosuppressant medication.\n* Pregnant or breastfeeding women.\n* Subjects with inflammation, infection or cutaneous disorders, at the treatment site or nearby.\n* Subjects with bleeding disorders or in subjects receiving thrombolytic or anticoagulant treatment.\n* Areas other than those recommended by the IFU.\n* Subject deprived of liberty by judicial or administrative decision.\n* Adults under a legal protection measure (guardianship/curatorship).\n* Subject under legal protection order.'}, 'identificationModule': {'nctId': 'NCT07255261', 'briefTitle': 'Evaluation of Facial HA Dermal Fillers in Real-Life Conditions', 'organization': {'class': 'INDUSTRY', 'fullName': 'Symatese'}, 'officialTitle': 'Post-Marketing Clinical Follow Up On Hyaluronic Acid-Based Dermal Fillers Using COLD-X™ Technology By Symatese', 'orgStudyIdInfo': {'id': 'CLIN2108_CIP'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Aesthetic treatment with hyaluronic acid (HA) of one or more regions of the face.', 'description': 'Based on their preferences and with the agreement of the healthcare professional, subjects may receive aesthetic treatments of the lips, perioral lines, nasolabial folds, cheeks, and/or infraorbital hollows.', 'interventionNames': ['Device: Facial injection of hyaluronic acid-based dermal fillers.']}], 'interventions': [{'name': 'Facial injection of hyaluronic acid-based dermal fillers.', 'type': 'DEVICE', 'description': 'Facial injection of hyaluronic acid-based dermal fillers USING COLD-X™ TECHNOLOGY by Symatese.', 'armGroupLabels': ['Aesthetic treatment with hyaluronic acid (HA) of one or more regions of the face.']}]}, 'contactsLocationsModule': {'locations': [{'zip': '62000', 'city': 'Arras', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Cyril Maire', 'role': 'CONTACT', 'email': 'maire.dermatologie@hotmail.fr', 'phone': '+33 3 21 71 34 34'}], 'facility': 'Centre Médical Saint Jean', 'geoPoint': {'lat': 50.29301, 'lon': 2.78186}}, {'zip': '69005', 'city': 'Lyon', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Amandine CATELAIN-LAMY', 'role': 'CONTACT', 'email': 'amandinelamy28@icloud.com', 'phone': '+33 4 78 36 85 85'}], 'facility': 'Cabinet médical', 'geoPoint': {'lat': 45.74906, 'lon': 4.84789}}, {'zip': '69006', 'city': 'Lyon', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Sophie Converset', 'role': 'CONTACT', 'email': 'drconverset@gmail.com', 'phone': '+33 4 78 41 88 85'}], 'facility': 'Palais de Flore', 'geoPoint': {'lat': 45.74906, 'lon': 4.84789}}, {'zip': '91120', 'city': 'Palaiseau', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Diala Haykal', 'role': 'CONTACT', 'email': 'docteur.haykal@gmail.com', 'phone': '+33 1 60 10 64 55'}], 'facility': 'Centre Laser Palaiseau', 'geoPoint': {'lat': 48.71828, 'lon': 2.2498}}, {'zip': '75004', 'city': 'Paris', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Arnaud Lambert', 'role': 'CONTACT', 'email': 'aldermoaesthetic@gmail.com', 'phone': '+33 1 40 61 91 58'}], 'facility': 'Aesthé - Marais.', 'geoPoint': {'lat': 48.85341, 'lon': 2.3488}}, {'zip': '75008', 'city': 'Paris', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Jean-Jacques DEUTSCH', 'role': 'CONTACT', 'email': 'deutschjj@gmail.com', 'phone': '+33 1 47 20 05 03'}], 'facility': 'Cabinet médical', 'geoPoint': {'lat': 48.85341, 'lon': 2.3488}}, {'zip': '75116', 'city': 'Paris', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Sylvie Poignonec', 'role': 'CONTACT', 'email': 'sylvie@poignonec.com', 'phone': '+33 1 45 63 13 20'}], 'facility': 'Cabinet médical', 'geoPoint': {'lat': 48.85341, 'lon': 2.3488}}, {'zip': '94100', 'city': 'Saint-Maur-des-Fossés', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Elisabeth DOMERGUE THAN TRONG', 'role': 'CONTACT', 'email': 'elisabeth.domergue.than.trong@gmail.com', 'phone': '+33 1 42 83 38 18'}], 'facility': 'Cabinet médical', 'geoPoint': {'lat': 48.79395, 'lon': 2.49323}}], 'centralContacts': [{'name': 'Valentin BONVALET', 'role': 'CONTACT', 'email': 'v.bonvalet@symatese.com', 'phone': '+33 (0)4 78 56 72 80'}, {'name': 'Sébastien GUYON', 'role': 'CONTACT', 'email': 's.guyon@symatese.com', 'phone': '+33 (0)4 78 56 72 80'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Symatese', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}