A Clinical Investigation of the Decoria® Aesthetic Group (DAG) for Correction of Nasolabial Folds… (NCT05235126) | Clinical Trial Compass
CompletedNot Applicable
A Clinical Investigation of the Decoria® Aesthetic Group (DAG) for Correction of Nasolabial Folds (NLF)
Sweden94 participantsStarted 2022-02-17
Plain-language summary
Decoria intense is a class III medical device and is CE-marked and has been on the market since 2014. Decoria intense is a hyaluronic acid filler that will be used according to intended use for correction of nasolabial folds.
According to the new MDR in EU this clinical investigation will confirm efficacy and safety of Decoria intense.
The plan is to recruit 80 subjects to receive 64 evaluable subjects during 6 months recruitment.
The clinical investigation contains 5 visits and the total time per subject is 12 months. All subjects will receive treatment at Visit 1 with the option to receive a touch-up treatment at Visit 2. Evaluation of the nasolabial folds will be performed by PI using the Wrinkle Severity Rating Scale (WSRS)
Who can participate
Age range
18 Years
Sex
ALL
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
. Male or Female, ≥18 years of age, of all weight spans, desiring correction of their nasolabial folds.
. The subject is legally competent, has been informed of the nature, the scope and the relevance of the study, voluntarily agrees to participation and the study's provisions, and has duly signed the Informed Consent Form (ICF).
. The subject has nasolabial folds considered at least moderate (grade 3) according to the Wrinkle Severity Rating Scale (WSRS), as assessed by the Principal Investigator.
Exclusion criteria
. Pregnant or lactating females.
. Any previous hypersensitivity reaction to any constituent of the Investigational medical device (IMD) or to local anaesthetic products.
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
1
Change in the WSRS score
Timeframe: 3 months after pre-treatment (baseline)
. Any acute or chronic skin disease or inflammation (such as pimples, rashes or hives) within or close to the area selected for correction.
. Any bleeding disorder or treatment with thrombolytics or anticoagulants.
. Any treatment with interferon and ribavirin.
. Any vaccine taken within 2 weeks prior to the treatment visit.
. Any other intradermal injection, such as fillers or toxins, received in the same injection area within 6 months of the Screening and Treatment visit (Visit 1).
. Participation in a clinical investigation study that may affect the safety or performance of this investigation, within one year of enrolment, or planned participation in such investigation at any time during this clinical investigation, as judged by the Principal Investigator.