Clinical investigation evaluating the safety and effectiveness of STIM+ injectable medical device in the treatment of midface volume deficit
Midface volume deficit
The design project name is STIM+ (project code DF-STIM1), and the commercial name is Hydroxyal + Sterile injectable medical device for facial aesthetic treatment. STIM+ (Hydroxyal+ - DF-STIM1) is a sterile injectable CaHA-based resorbable gel containing synthetic calcium hydroxyapatite (56% w/v) in a NaCMC/glycerin/PBS carrier, with lidocaine hydrochloride (3 mg/g - 0.3%) as an ancillary medicinal substance. This investigation will include 75 participants to reach 60 evaluable and will be conducted as a single-arm, open-label, single-centre prospective study at CIDP Mauritius over a 52-week follow-up period, with the primary effectiveness assessment at 4 weeks and durability/safety follow-up at 26 and 52 weeks. The dosage of STIM+ is individualized based on the participant’s anatomical characteristics and the severity of the midface volume deficit, as assessed by the investigator. The device is administered by deep dermal or subdermal injection using a slow, retrograde technique in micro-aliquots. The volume injected per cheek should not exceed 2 ml per session, in accordance with the Instructions for Use. STIM+ is supplied with pre-filled syringes of 1.5 ml, and one or more syringes may be used to achieve the desired correction without exceeding the recommended limits. Each box contains one graduated pre-filled 1.5 ml syringe of HYDROXAL+, a set of implant cards to ensure traceability, and an instruction leaflet.
1. Male and female participants aged 30 to 70 years old 2. Any phototype 3. Any ethnicity (30% Caucasian panel) 4. Presenting Grade 2-4 on the Allergan Cheek Volume Scale 5. Seeking aesthetic treatment for midface (cheek) volume deficit 6. Willing to abstain from other facial aesthetic procedures in the mid-face during the study 7. Participants who have given their consent for photographs for illustration purposes 8. Participants in good general and mental health as determined by the investigator 9. Participants who can read and fully understand the aims of the study and its conduct and have given their free, informed and expressed written consent 10. Participants agree to cooperate, in full awareness of the study objectives, the necessity and the duration of the follow-up controls at the trial site to ensure perfect adherence to CIP 11. Participants who, in the judgement of the investigator, are likely to be compliant during the study 12. Participants are willing and capable of following the study rules and a fixed schedule 13. Participants are willing and capable of signing an informed consent document (including the language)
1. Participants with any systemic disorder or skin disease that would in any way confound interpretation of the study results 2. Participants with medical/surgical/severe allergy/anaphylactic shock history that, in the opinion of the Investigator, could compromise the safety of the participant or affect the outcome of the study 3. Participants have known risk of hypersensitivity to one of the components of the composition 4. Participants suffering from autoimmune disease 5. Participants having cutaneous disorders, inflammation or infection (herpes, acne, etc) at the treatment site or nearby 6. Participants for whom medical history shows a sensitivity that could lead to a reaction to the treatment 7. Participants with bleeding disorders or in participants who are undergoing treatment with thrombolytics or anticoagulants 8. Participants with a tendency to form keloids, hypertrophic scars or any other healing disorders 9. Participants who are currently following skin treatment 10. Pregnant or breastfeeding women or those considering a pregnancy during the study 11. Female participants of childbearing potential with a positive urine pregnancy test (UPT) at D-3-D0 visit 12. Participants who have been deprived of their freedom by administrative or legal decision or who are under guardianship 13. Participants who cannot be contacted by telephone in case of emergency 14. Participants in an exclusion period or participating in another biomedical research study (self-reported) 15. Intellectual/mental inability to follow study instructions (if suspected) or incapacitation 16. Prior adverse reaction to hyaluronic acid treatment (injectable or over-the-counter topical) 17. Connective tissue disorder 18. Active infection in treatment area 19. Active severe inflammatory disease in treatment areas such as atopic dermatitis and psoriasis 20. Treatment with toxin or filler in lower face below the orbital rim within the past 6 months