Princess® RICH for the Correction of Fine Lines (NCT03923634) | Clinical Trial Compass
CompletedNot Applicable
Princess® RICH for the Correction of Fine Lines
Austria102 participantsStarted 2018-10-16
Plain-language summary
Eligible subjects deemed by the treating physician to have sufficient severity to merit treatment of either their lateral canthal lines (LCL) or perioral rhytids (PR) or both will be treated with Princess® RICH at the Baseline visit and at week 3 and 6.
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:
* Subjects deemed by the treating physician to have LCL and/or PR of sufficient baseline severity to merit treatment with Princess® RICH to be corrected
* A negative urine pregnancy test at Visit 1 and commitment to use an adequate method of birth control for the duration of the clinical investigation (for women of childbearing potential only.)
* Healthy skin in the facial area and free of diseases that could interfere in cutaneous aging evaluation
* Willingness to abstain from any aesthetic or surgical procedures in the treatment area for the duration of the clinical investigation
* Written signed and dated informed consent
Exclusion Criteria:
* Tendency to hypertrophic scars, pigment disorders or keloid formation.
* History of autoimmune disease or receiving therapy for modification of immune response
* Hypersensitivity to hyaluronic acid or glycerol.
* Permanent fillers in the areas to be treated.
* Subjects who are pregnant or breast feeding.
* Subjects who are anticoagulated or with history of bleeding disorder.
* Daily treatment with platelet aggregation inhibitors unless previously cleared by their primary care physician.
* Cutaneous, inflammatory and/or infectious processes present at V0, recurrent herpes simplex or (pre) cancerous lesions in the areas to be treated
* Known Diabetes mellitus or uncontrolled systemic diseases in the assessment of the investigator.
* Laser therapy, chemical peeling, dermabrasion or botulin toxin treatment in the a…
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
Effectiveness of Princess® RICH to correct fine lines on the face including lateral canthal lines (LCL) and perioral rhytids (PR)