Princess® RICH for the Correction of Fine Lines (RICH)

A Prospective Open-label, Multicenter Study Evaluating Princess® RICH in Correction of Fine Lines

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.

Study Overview

• Status: Completed
• Conditions: Lateral Canthal Lines; Perioral Rhytids
• Intervention / Treatment: Device: Princess® RICH

• Study Type: Interventional
• Enrollment (Actual): 102
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Austria
  • Graz, Austria
    • MaRa-Medical Aesthetic Research Academy
  • Graz, Austria
    • Medizinische Universität-Klinikum für Dermatologie und Venerologie
  • Vienna, Austria
    • Yuvell

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 area to be treated within less than three months prior to and during the course of the study.
• Current participation in another clinical investigation
• Subjects whose participation in clinical trials is prohibited by the Austrian Medical Devices Act (e.g, persons with a legal custodian appointed due to mental disability, prisoners, soldiers and other members of the armed forces, civil servants)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: OTHER
• Allocation: NA
• Interventional Model: SINGLE_GROUP
• Masking: NONE

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Princess® RICH; Eligible subjects will be injected with Princess® RICH (this is an open-label study). Princess® RICH is injected into the lateral canthal lines and/or perioral rhytids.	Device: Princess® RICH; Princess® RICH is injected into lateral canthal lines and/or perioral rhytids

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Effectiveness of Princess® RICH to correct fine lines on the face including lateral canthal lines (LCL) and perioral rhytids (PR)	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	Week 8 compared to Baseline

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Effectiveness of Princess® RICH to correct fine lines on the face including lateral canthal lines (LCL) and perioral rhytids (PR)	Percentage of responders at week 12 and 16.	Week 12 and 16 compared to Baseline
Ability of Princess® RICH to improve skin hydration	Change from baseline at weeks 3, 6, 8, 12 and 16 in skin hydration. Skin hydration is measured using a corneometer device.	Week 3, 6, 8, 12 and 16 compared to Baseline
Ability of Princess® RICH to improve skin tone	Changes from baseline at weeks 3, 6, 8, 12 and 16 in skin tone. Skin tone is measured using a cutometer device.	Week 3, 6, 8, 12 and 16 compared to Baseline
Ability of Princess® RICH to improve skin elasticity	Change from baseline at weeks 3, 6, 8, 12 and 16 in skin elasticity. Skin elasticity is measured using a cutometer device.	Week 3, 6, 8, 12 and 16 compared to Baseline
Subject satisfaction with treatment	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".	Week 8, 12 and 16

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Ocurrence and frequency of adverse events	Assessment of occurrence and frequency of adverse events	Throughout the study (16 weeks)

Collaborators and Investigators

• Sponsor: Croma-Pharma GmbH
• Investigators: Principal Investigator: Monika Sulovsky, MD, Yuvell; Principal Investigator: Daisy Kopera, MD, Medizinische Universität Graz- Klinikum für Dermatologie und Venerologie; Principal Investigator: Thomas Rappl, MD, MaRa-Medical Aesthetic Research Academy

Study record dates

Study Major Dates

• Study Start (ACTUAL): October 16, 2018
• Primary Completion (ACTUAL): April 29, 2019
• Study Completion (ACTUAL): October 22, 2019

Study Registration Dates

• First Submitted: April 8, 2019
• First Submitted That Met QC Criteria: April 19, 2019
• First Posted (ACTUAL): April 22, 2019

Study Record Updates

• Last Update Posted (ACTUAL): March 2, 2021
• Last Update Submitted That Met QC Criteria: March 1, 2021
• Last Verified: March 1, 2021

More Information

Terms related to this study

• Other Study ID Numbers: CPH-401-201364

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No