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Tests treatment safety and results for Wrinkle
Official title Evaluation of Performance and Safety of INNEA and INNEA AQUA for the Treatment of Cheek and décolletage Wrinkles
ClinicalTrials.gov ID: NCT07331181
What this study is testing
- What it's testing
- 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
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 35 to 65, women only. Healthy volunteers may be eligible.
You may be able to join if
- Patient Informed consent form (ICF) signed;
- Female people between 35 and 65 years old at the time of the signature of ICF;
- people with at least 2 (shallow wrinkles) on the Lemperle Rating Scale requiring correction of cheek wrinkles and/or people requiring correction of...
- Willingness to follow all study procedures, including attending all site visits, tests and examinations;
- Agreeing to present at each study visit without make-up;
You likely can't join if
- Other - different - clinical conditions of the skin (i.e. rosacea,psoriasis, vitiligo, active eczema, severe scleroderma, severe acne and...
See the full eligibility criteria
- Patient Informed consent form (ICF) signed;
- Female people between 35 and 65 years old at the time of the signature of ICF;
- people with at least 2 (shallow wrinkles) on the Lemperle Rating Scale requiring correction of cheek wrinkles and/or people requiring correction of décolletage wrinkles;
- Willingness to follow all study procedures, including attending all site visits, tests and examinations;
- Agreeing to present at each study visit without make-up;
- 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...
- Willingness to follow indications to not be exposed to make-up for 12 hours after injection;
- Willingness to avoid prolonged exposure to sunlight and UV or using saunas or Turkish baths for one week after the injection.
- 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...
The study team makes the final eligibility decision.
Where it's taking place
- Brescia, Brescia, Italy
- Rozzano, MI, Italy
- Roma, Roma, Italy
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling female, 35 years to 65 years. Healthy volunteers may be eligible. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Brescia, Brescia, Italy; Rozzano, MI, Italy; Roma, Roma, Italy. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.