Status:
NOT_YET_RECRUITING
Efficacy and Safety of "LMW - CL - HA - FACE/BODY" for the Augmentation of the Cheeks
Lead Sponsor:
Rose Pharma SA
Conditions:
Esthetics
Eligibility:
All Genders
18-75 years
Phase:
NA
Brief Summary
Midface volume loss is a typical sign of facial aging. Age-related loss of subcutaneous fullness in the malar prominence results in a less healthy facial proportion. Indeed, the primary goal in any re...
Eligibility Criteria
Inclusion
- Subject Informed consent form (ICF) signed;
- Female and male Subjects aged 18-75 years;
- Subjects with low moderate and moderate kind of skin sagging of the face (FVLS between 2 and 4 score) desiring augmentation of both cheeks;
- Willingness to follow all study procedures, including attending all site visits, tests and examinations;
- Agreeing to present at each study visit without make-up;
- Accepting to not change their habits regarding food, physical activity, make-up use, face cosmetic and cleansing products;
- Willingness to follow indications to not be exposed to make-up, excessive heat (sun, UV tanning sessions or laser) or intense cold after the treatment and until the complete absorption of swelling and reddening.
Exclusion
- Subjects with asymmetries in the cheeks, which in the opinion of the PI could require treatment of only one side of the face, prior to study inclusion; 2. Other - different - clinical conditions of the skin (i.e. rosacea, psoriasis, vitiligo, active eczema, severe scleroderma, severe acne and diagnosticated cancer with/without ongoing antitumor therapy); 3. Botulinum toxin injections in face areas other than forehead, lips, chin within 6 months prior to study inclusion; 4. Infectious or inflammatory processes near the area of intervention or in the face in general; 5. Presence of cutaneous disease on the tested area, as malformations and recurrent facial/labial herpes; 6. Presence of tendon, bone or muscular implants near the area of intervention; 7. Presence of hypertrophic scars near the area of treatment; 8. Presence of permanent filler, of traction wires or prostheses in the face; 9. Ongoing cutaneous allergies; 10. Known hypersensitivity to cheloids; 11. Allergy or contraindications to device components; 12. Immune system illnesses/disease; 13. Uncontrolled diabetes mellitus or uncontrolled systemic diseases (endocrine, hepatic renal, cardiac, pulmonary, neurological disorder); 14. Problems with coagulation or anti-coagulating therapies in progress; 15. Treatment with substances which act on blood fluidity (e.g. Aspirin, NSAIDs, Vitamin E) within 5 days prior to study inclusion; based on Investigator's judgment cardioaspirin might be allowed; 16. Known drug and/or alcohol abuse; 17. Mental incapacity that precludes adequate understanding or cooperation; 18. Any previous permanent and non-permanent cutaneous treatment for aesthetic correction (biomaterial implant, lifting, laser, chemical peeling, fillers) of the face within 6 months prior to study inclusion; 19. Pregnancy or breastfeeding; 20. Dental pathologies: tooth decay, abscesses, preparation for implants; 21. Participation in another investigational study within 1 month prior to study inclusion.
Key Trial Info
Start Date :
April 1 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 31 2025
Estimated Enrollment :
26 Patients enrolled
Trial Details
Trial ID
NCT06915402
Start Date
April 1 2025
End Date
December 31 2025
Last Update
April 8 2025
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