RecruitingNot Applicable

Evaluation of Performance and Safety of INNEA and INNEA AQUA for the Treatment of Cheek and décolletage Wrinkles

Italy55 participantsStarted 2023-06-01

Plain-language summary

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

Who can participate

Age range

35 Years – 65 Years

Sex

FEMALE

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

. 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;
. 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, bio-stimulating treatment, chemical peeling, dermabrasion, fillers) during the entire study period;
. 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.

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Lemperle Rating scale

Timeframe: 1 month after the last injections

GAIS for improvement

Timeframe: One month after the injections

Trial details

NCT IDNCT07331181

SponsorInnate srl

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2024-11-30

View on ClinicalTrials.gov More Wrinkle trials