Princess® RICH
DevicePrincess® RICH is injected into lateral canthal lines and/or perioral rhytids
NCT Number: NCT03923634
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.
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Notify Me18 year and older
All sexes
Interventional
Not applicable
MaRa-Medical Aesthetic Research Academy, Graz, Austria
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Princess® RICH is injected into lateral canthal lines and/or perioral rhytids
Time frame: Week 8 compared to Baseline
Percentage of responders at week 8 Responder is defined as at least "improved" versus baseline in the fine lines of lateral canthal lines (LCL) and/or perioral rhytids (PR) assessed with the GAIS (Gloabel Aesthetic Improvement Scale)
Global aesthetic improvement can be rated as 'very much improved', 'much improved', 'improved', 'no change' or 'worse
Time frame: Week 12 and 16 compared to Baseline
Percentage of responders at week 12 and 16.
Time frame: Week 3, 6, 8, 12 and 16 compared to Baseline
Change from baseline at weeks 3, 6, 8, 12 and 16 in skin hydration. Skin hydration is measured using a corneometer device.
Time frame: Week 3, 6, 8, 12 and 16 compared to Baseline
Changes from baseline at weeks 3, 6, 8, 12 and 16 in skin tone. Skin tone is measured using a cutometer device.
Time frame: Week 3, 6, 8, 12 and 16 compared to Baseline
Change from baseline at weeks 3, 6, 8, 12 and 16 in skin elasticity. Skin elasticity is measured using a cutometer device.
Time frame: Week 8, 12 and 16
Subject satisfaction with treatment at weeks 8, 12 and 16. Satisfaction with the treatment will be graded using one of the following categories: "Very unsatisfied", "Unsatisfied", "Neither unsatisfied nor satisfied", "Satisfied", or "Very satisfied".
Time frame: Throughout the study (16 weeks)
Assessment of occurrence and frequency of adverse events
Croma-Pharma GmbH
Industry
A Prospective Open-label, Multicenter Study Evaluating Princess® RICH in Correction of Fine Lines
Acronym: RICH
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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