About this trial
A Post-Market, Single-arm, Confirmatory Interventional Clinical Investigation to evaluate the Performance and Safety of INNEA and INNEA AQUA for the treatment of cheek and décolletage wrinkles
Eligibility criteria
This trial accepts healthy volunteersQualifiers
Patient Informed consent form (ICF) signed;
Female Subjects between 35 and 65 years old at the time of the signature of ICF;
Subjects with at least 2 (shallow wrinkles) on the Lemperle Rating Scale requiring correction of cheek wrinkles and/or subjects requiring correction of décolletage wrinkles;
Willingness to follow all study procedures, including attending all site visits, tests and examinations;
Disqualifiers
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); 2. Infectious or inflammatory processes near the area of intervention; 3. Presence of naevi in the area to be injected; 4. Ongoing use or exposure to benzalkonium chloride solutions; 5. Patients who tend to develop hypertrophic scarring; 6. Patients with a history of autoimmune disease or who are receiving immune therapy; 7. Patients who are known to be hypersensitive to hyaluronic acid; 8. Presence of cutaneous disease on the tested area, as lesions, malformations and recurrent facial/labial herpes; 9. Presence of tendon, bone or muscular implants near the areaof intervention; 10. Ongoing cutaneous allergies; 11. Known hypersensitivity to cheloids; 12. Allergy or contraindications to device components; 13. Allergy or contraindication to one of the components of local anesthetic (patch or cream); 14. Immune system illnesses; 15. Diabetes mellitus or uncontrolled systemic diseases (endocrine, hepatic renal, cardiac, pulmonary, neurological disorder); 16. Problems with coagulation or undergoing anticoagulant therapy; 17. Patients who are using substances that can prolong bleeding(such as aspirin, nonsteroidal anti-inflammatory drugs, and warfarin); 18. Current treatment with anti-inflammatory drugs, anti-histaminic, topic and systemic corticosteroids, narcotic, antidepressant, immunosuppressive drugs (with the except of contraceptive or hormonal treatment starting more than 1 year ago), drugs able to influence the test results in the investigator opinion; 19. Known drug and/or alcohol abuse; 20. Mental incapacity that precludes adequate understanding or cooperation; 21. Any previous permanent and nonpermanent cutaneous treatment for aesthetic correction (e.g., ultrasound-based treatments, biomaterial implant, lifting, botulinum toxin injections, laser or intense pulsed light treatment, bio-stimulating treatment, chemical peeling, dermabrasion, fillers) within 6 months prior to study inclusion; 22. Active malignant neoplasm of any type, or history of a malignancy (patients with a history of other malignancies that have been surgically removed and who have no evidence of recurrence for at least five years before study enrollment are also acceptable); 23. Pregnancy or breastfeeding; 24. COVID-19 vaccination within one month prior to study inclusion; 25. Current participation in a similar study or during the previous 3 months.
Trial design
Single group
Treatments tested in this trial
Innea, Innea Aqua
DeviceINNEA: one syringe contains 2.0 ml of non-pyrogenic gel. The gel is based on the following: sodium hyaluronate 20 mg/ml INNEA AQUA: one syringe contains 2.0 ml of non- pyrogenic gel. The gel is based on sodium hyaluronate 25 mg/ml, trehalose
Treatment groups
Trial outcomes
Primary outcomes
Lemperle Rating scale
To evaluate the performance of INNEA and INNEA AQUA for the treatment of cheek and décolletage wrinkles after 1 month from the last injection, the lamperle Rating scale will be used: \- The Lemperle Rating Scale (LRS) will be used to assess cheek wrinkles at V4 (1 month after the 3rd injection) by study product.
GAIS for improvement
The Global Aesthetic Improvement Scale (GAIS) scale will be used to assess improvement of décolletage wrinkles at V4 (1 month after the 3rd injection) by study product.
Secondary outcomes
Outcome for performance with Lemperle Rating scale (LRS)
1\. To evaluate the performance of INNEA and INNEA AQUA for the treatment of cheek wrinkles at each visit and décolletage wrinkles at each post-treatment assessment, the LRS (for cheek wrinkles) at each visit. This scale is used because is based on standardized 6-point (0-5) clinical tool used by dermatologists and plastic surgeons to assess the severity of facial wrinkles and folds, aiding in evaluating the effectiveness of injectable fillers and, anti-aging treatments. It measures wrinkles based on depth, ranging from 0 (no wrinkles) to 5 (extremely deep wrinkles/folds). The success is based on the % of improvement in the state of the wrinkles.
Outcome safety: evaluation of adverse events
To assess the safety and tolerability of INNEA and INNEA AQUA evaluation of the frequency of adverse events (AEs) and type
Performance with Gais
To evaluate the performance of INNEA and INNEA AQUA to improve aesthetic appearance of the face, the GAIS will be used at each post-treatment assessment.
Performance with Likert scale
To evaluate the performance of INNEA and INNEA AQUA to improve skin radiance and turgor of cheek and décolletage, a 5- Likert scale will be used at each visit.
Other outcomes
Device deficiency
Device deficiency/incidents will be monitored at V0, V1, V2.
Evaluation during the duration of the study with diary
Concomitant medications and AEs will be monitored during the entire duration of the study through a diary dispensed to patients at V0.
Sponsors and contacts
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Innate srl
Lead sponsor
1Med
Collaborator