Skip to main content
OpenTrials
Completed

NCT Number: NCT03923634

Princess® RICH for the 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.

Completed

Looking for future studies?

Notify Me

Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

MaRa-Medical Aesthetic Research Academy, Graz, Austria

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Princess® RICH

Device

Princess® RICH is injected into lateral canthal lines and/or perioral rhytids

Primary outcomes

  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 outcomes

  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 outcomes

  1. Ocurrence and frequency of adverse events

    Time frame: Throughout the study (16 weeks)

    Assessment of occurrence and frequency of adverse events

Sponsors and collaborators

Lead sponsor

Croma-Pharma GmbH

Industry

Registry information

Official study title

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

Acronym: RICH

Important dates

Study start
2018
Primary completion
2019
Study completion
2019
First posted
Apr 22, 2019
Registry last updated
Dec 10, 2024

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.

Published trials that share one or more normalized conditions with this study.