INNEA and INNEA AQUA injections for cheek and décolletage wrinkles

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

This will test whether INNEA and INNEA AQUA injections reduce cheek and décolletage wrinkles in women aged 35–65.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 55 (estimated)
• Ages: 35 Years to 65 Years
• Sex: Female
• Sponsor: Innate srl (Industry-sponsored)
• Locations: 3 sites (Brescia, Brescia and 2 other locations)
• Trial ID: NCT07331181 on ClinicalTrials.gov

What this trial studies

This post‑market, single‑arm, confirmatory interventional investigation will enroll adult women with cheek and/or décolletage wrinkles to receive intradermal injections of INNEA or INNEA AQUA, both CE‑marked hyaluronic acid fillers. Participants must be female, 35–65 years old, with at least shallow wrinkles (Lemperle score ≥2) and will follow scheduled visits for clinical assessment and safety monitoring. The protocol standardizes post‑treatment care (no makeup for 12 hours, limited sun/sauna exposure) and prohibits other aesthetic procedures during follow-up. Outcomes include wrinkle performance measures, photographic documentation, and recording of adverse events.

Who should consider this trial

Good fit: Adult women aged 35–65 with at least shallow (Lemperle score ≥2) cheek or décolletage wrinkles who are willing to attend visits and avoid other aesthetic procedures during the study.

Not a fit: Men, people outside the 35–65 age range, those with very deep or fibrotic scars, recent aesthetic treatments, or allergies to hyaluronic acid are unlikely to benefit from this investigation.

Why it matters

Potential benefit: If successful, treated patients could have smoother, more hydrated skin with visibly reduced cheek and décolletage wrinkles using a CE‑marked hyaluronic acid filler.

How similar studies have performed: Hyaluronic acid fillers are widely used and have substantial evidence for improving facial wrinkle appearance, and this trial is a confirmatory assessment of a CE‑marked formulation.

Eligibility criteria

Inclusion Criteria:

1. Patient Informed consent form (ICF) signed;
2. Female Subjects between 35 and 65 years old at the time of the signature of ICF;
3. 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;
4. Willingness to follow all study procedures, including attending all site visits, tests and examinations;
5. Agreeing to present at each study visit without make-up;
6. Willingness not to undergo other procedures involving 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) during the entire study period;
7. Willingness to follow indications to not be exposed to make-up for 12 hours after injection;
8. Willingness to avoid prolonged exposure to sunlight and UV or using saunas or Turkish baths for one week after the injection.

Exclusion Criteria:

* 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.

Where this trial is running

Brescia, Brescia and 2 other locations

• ASST degli Spedali Civili di Brescia — Brescia, Brescia, Italy (Recruiting)
• Humanitas Research Hospital — Rozzano, Mi, Italy (Recruiting)
• Campus Biomedico — Roma, Roma, Italy (Recruiting)

Conditions Wrinkle; Aging; wrinkles; aging of the skin; Innea-2022