Evaluation of Facial HA Dermal Fillers in Real-Life Conditions
NCT ID: NCT07255261
Last Updated: 2025-12-08
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
460 participants
INTERVENTIONAL
2025-07-02
2028-07-31
Brief Summary
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Participants 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.
If 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.
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Aesthetic treatment with hyaluronic acid (HA) of one or more regions of the face.
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.
Facial injection of hyaluronic acid-based dermal fillers.
Facial injection of hyaluronic acid-based dermal fillers USING COLD-X™ TECHNOLOGY by Symatese.
Interventions
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Facial injection of hyaluronic acid-based dermal fillers.
Facial injection of hyaluronic acid-based dermal fillers USING COLD-X™ TECHNOLOGY by Symatese.
Eligibility Criteria
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Inclusion Criteria
* Subject who agreed to participate and have signed an informed consent.
* Age: over 18 years old.
* Subject being affiliated to a health social security system.
Exclusion Criteria
* Subjects with a known allergy to hyaluronic acid, lidocaine or amide local anesthetics.
* Subjects with porphyria.
* Subjects with an autoimmune disorder, or using an immunosuppressant medication.
* Pregnant or breastfeeding women.
* Subjects with inflammation, infection or cutaneous disorders, at the treatment site or nearby.
* Subjects with bleeding disorders or in subjects receiving thrombolytic or anticoagulant treatment.
* Areas other than those recommended by the IFU.
* Subject deprived of liberty by judicial or administrative decision.
* Adults under a legal protection measure (guardianship/curatorship).
* Subject under legal protection order.
18 Years
ALL
Yes
Sponsors
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Symatese
INDUSTRY
Responsible Party
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Locations
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Centre Médical Saint Jean
Arras, , France
Cabinet médical
Lyon, , France
Palais de Flore
Lyon, , France
Centre Laser Palaiseau
Palaiseau, , France
Aesthé - Marais.
Paris, , France
Cabinet médical
Paris, , France
Cabinet médical
Paris, , France
Cabinet médical
Saint-Maur-des-Fossés, , France
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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CLIN2108_CIP
Identifier Type: -
Identifier Source: org_study_id
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