Actively Recruiting
Evaluation of Performance and Safety of INNEA and INNEA AQUA for Treating Cheek and Décolletage Wrinkles
Led by Innate srl · Updated on 2026-04-16
55
Participants Needed
3
Research Sites
108 weeks
Total Duration
On this page
Sponsors
I
Innate srl
Lead Sponsor
1
1Med
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are evaluating the performance and safety of two medical devices, INNEA and INNEA AQUA, for treating wrinkles on the cheeks and décolletage in adult women aged 35 to 65 years. These devices are biodegradable dermal fillers made from different types of hyaluronic acid. The study aims to confirm the devices' effects on skin aging signs, such as wrinkles and skin radiance, while monitoring safety. This is a post-market, single-arm, interventional clinical investigation. Participants will receive three intradermal injections of either INNEA or INNEA AQUA at one-week intervals. Treatments can be applied to the cheek, décolletage, or both areas, using the same device for all three injections. The study includes a screening phase followed by five planned visits during which performance and safety assessments will be conducted. The treatments are delivered using sterile syringes and needles designed for intradermal injection. Throughout the study, researchers will collect demographic and medical history data and assess wrinkle improvement using the Lemperle Rating Scale for cheeks and the Global Aesthetic Improvement Scale for décolletage and overall facial appearance. Participants will rate their skin radiance and firmness, and pain intensity after each injection will be recorded. Safety monitoring will include vital signs and skin reactions at each visit. Patient satisfaction will be evaluated with a 5-point Likert scale at the end of the study. The total participation period covers baseline and follow-up visits over approximately one month after the last injection.
CONDITIONS
Brief 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
- Female between 35 and 65 years old at consent
- At least two shallow cheek wrinkles or décolletage wrinkles needing correction
- Willing to attend all study visits, tests, and examinations
- Agree to come to visits without makeup
- Agree not to undergo other aesthetic correction procedures during the study
- Agree not to use makeup for 12 hours after injection
- Agree to avoid prolonged sun exposure, UV, saunas, or Turkish baths for one week after injection
You will not qualify if you...
- Skin conditions like rosacea, psoriasis, vitiligo, eczema, severe scleroderma, severe acne, or cancer
- Infection or inflammation near treatment area
- Moles in treatment area
- Use of benzalkonium chloride solutions
- Tendency to develop hypertrophic scarring
- History of autoimmune disease or immune therapy
- Known allergy to hyaluronic acid or device components
- Skin disease or lesions on treated area
- Presence of implants near treatment area
- Ongoing skin allergies or hypersensitivity to keloids
- Allergy to local anesthetics
- Immune system illnesses
- Diabetes or uncontrolled systemic diseases
- Blood clotting problems or anticoagulant use
- Use of medications that affect bleeding or immune response
- Drug or alcohol abuse
- Mental incapacity affecting cooperation
- Recent aesthetic treatments within 6 months
- Active or recent cancer
- Pregnancy or breastfeeding
- COVID-19 vaccination within 1 month prior
- Participation in similar study within last 3 months
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Screening and enrollment visit may occur on the same day if all tests can be performed together.
Duration - 3 weeks
Participants receive three injections of either INNEA or INNEA AQUA in the cheek and/or décolletage areas, with one injection per week.
3 visits for injections, one per week
Duration - Up to 1 month after the last injection
After the treatment, participants attend scheduled visits to assess performance, safety, pain, and satisfaction.
2 post-treatment visits including the end of study visit
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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