Actively Recruiting
Evaluation of Performance and Safety of INNEA and INNEA AQUA for the Treatment of Cheek and décolletage Wrinkles
Led by Innate srl · Updated on 2026-04-16
55
Participants Needed
3
Research Sites
186 weeks
Total Duration
On this page
Sponsors
I
Innate srl
Lead Sponsor
1
1Med
Collaborating Sponsor
AI-Summary
What this Trial Is About
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
CONDITIONS
Official Title
Evaluation of Performance and Safety of INNEA and INNEA AQUA for the Treatment of Cheek and décolletage Wrinkles
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Signed informed consent form (ICF)
- Female between 35 and 65 years old at time of signing ICF
- At least 2 shallow wrinkles on cheeks or wrinkles on décolletage needing correction
- Willing to follow all study procedures including attending all visits, tests, and exams
- Agree to come to each visit without makeup
- Willing to avoid other aesthetic correction procedures during the study
- Willing to avoid makeup for 12 hours after each injection
- Willing to avoid prolonged sun exposure, UV, saunas, or Turkish baths for one week after injections
You will not qualify if you...
- Skin conditions such as rosacea, psoriasis, vitiligo, active eczema, severe scleroderma, severe acne, or cancer
- Infection or inflammation near the treatment area
- Presence of moles in the injection area
- Use or exposure to benzalkonium chloride solutions
- History of hypertrophic scarring
- Autoimmune disease or receiving immune therapy
- Known allergy to hyaluronic acid
- Skin diseases, lesions, malformations, or recurrent herpes in the treatment area
- Tendon, bone, or muscle implants near the treatment area
- Active skin allergies
- Known allergy to keloids
- Allergy to device or local anesthetic components
- Immune system illnesses
- Diabetes or uncontrolled systemic diseases
- Blood clotting problems or on anticoagulant therapy
- Using medications that prolong bleeding (e.g., aspirin, NSAIDs, warfarin)
- Current treatment with anti-inflammatory, antihistamine, corticosteroids, narcotics, antidepressants, immunosuppressants (except stable contraceptive or hormonal treatments)
- Known drug or alcohol abuse
- Mental incapacity affecting understanding or cooperation
- Previous permanent or nonpermanent aesthetic skin treatments within 6 months
- Active cancer or history of cancer without 5-year remission
- Pregnancy or breastfeeding
- COVID-19 vaccination within 1 month prior to inclusion
- Participation in a similar study currently or within past 3 months
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 3 locations
1
ASST degli Spedali Civili di Brescia
Brescia, Brescia, Italy, 25123
Actively Recruiting
2
Humanitas Research Hospital
Rozzano, MI, Italy, 20089
Actively Recruiting
3
Campus Biomedico
Roma, Roma, Italy
Actively Recruiting
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
OTHER
Number of Arms
1
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