About Bolder Science

Our mission is to provide healthcare professionals with unbiased clinical research information, easily.

Currently, you can access the following clinical trials being conducted worldwide:

378040 studies
in
220 countries
Clinical trial information and results are updated daily from ClinicalTrials.gov. The latest data update was conducted on 06/14/2021.
This website is for US healthcare professionals

Log In to Bolder Science

or

Don't have an account? Sign Up

Please enter your email address.

You will receive a link to create a new password via email.

Log In

Create an Account

or
(optional) ?

Welcome, !

Please complete the following 4 questions to ensure you receive the information that best suits your needs.

Clinical Trials of Interest

When I’m looking for information on clinical trials, I usually am interested in...

finding clinical trials in which to enroll my patients

Rarely Often

finding newly launched clinical trials (for all phases)

Rarely Often

updates on status changes for clinical trials

Rarely Often

pipeline molecules

Rarely Often

Drug Interventions

Enter up to 3 drug interventions you are currently interested in:

Clinical trial information and results are updated daily from ClinicalTrials.gov. The latest data update was conducted on 06/14/2021.

Princess® RICH for the Correction of Fine Lines

Clinicaltrials.gov identifier NCT03923634

Recruitment Status Completed

First Posted April 22, 2019

Last update posted March 2, 2021

Study Description

Brief 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.

  • Condition or Disease:Lateral Canthal Lines
    Perioral Rhytids
  • Intervention/Treatment: Device: Princess® RICH
  • Phase: N/A
Detailed Description

N/A

Study Design
  • Study Type: Interventional
  • Actual Enrollment: 102 participants
  • Intervention Model: Single Group Assignment
  • Masking: None (Open Label) ()
  • Primary Purpose: Other
  • Official Title: A Prospective Open-label, Multicenter Study Evaluating Princess® RICH in Correction of Fine Lines
  • Actual Study Start Date: October 2018
  • Actual Primary Completion Date: April 2019
  • Actual Study Completion Date: October 2019
Arms and interventions
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
Outcome Measures
  • Primary Outcome Measures: 1. Effectiveness of Princess® RICH to correct fine lines on the face including lateral canthal lines (LCL) and perioral rhytids (PR) [ 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
  • Secondary Outcome Measures: 1. Effectiveness of Princess® RICH to correct fine lines on the face including lateral canthal lines (LCL) and perioral rhytids (PR) [ Time Frame: Week 12 and 16 compared to Baseline ]
    Percentage of responders at week 12 and 16.
  • 2. Ability of Princess® RICH to improve skin hydration [ 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.
  • 3. Ability of Princess® RICH to improve skin tone [ 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.
  • 4. Ability of Princess® RICH to improve skin elasticity [ 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.
  • 5. Subject satisfaction with treatment [ 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".
  • Other Outcome Measures: 1. Ocurrence and frequency of adverse events [ Time Frame: Throughout the study (16 weeks) ]
    Assessment of occurrence and frequency of adverse events
Eligibility Criteria
  • Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
  • Sexes Eligible for Study: All
  • Accepts Healthy Volunteers: No
Criteria

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)

Contacts and Locations
Contacts
Locations

Austria
MaRa-Medical Aesthetic Research Academy
Graz

Austria
Medizinische Universität-Klinikum für Dermatologie und Venerologie
Graz

Austria
YUVELL
Vienna

Sponsors and Collaborators

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

More Information
  • Responsible Party: Croma-Pharma GmbH
  • ClinicalTrials.gov Identifier: NCT03923634 History of Changes
  • Other Study ID Numbers: CPH-401-201364
  • First Posted: April 22, 2019 Key Record Dates
  • Last Update Posted: March 2, 2021
  • Last Verified: March 2021
  • Studies a U.S. FDA-regulated Drug Product: No
  • Studies a U.S. FDA-regulated Device Product: No