Princess® RICH for the Correction of Fine Lines

NCT03923634 | Completed

• 1 other identifier: CPH-401-201364
• Study Type: interventional
• Target: 102
• Locations: 1 country
• Sites: 3

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.

Conditions

Lateral Canthal Lines; Perioral Rhytids

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (5)

• Effectiveness of Princess® RICH to correct fine lines on the face including lateral canthal lines (LCL) and perioral rhytids (PR)

  Week 12 and 16 compared to Baseline

• Ability of Princess® RICH to improve skin hydration

  Week 3, 6, 8, 12 and 16 compared to Baseline

• Ability of Princess® RICH to improve skin tone

  Week 3, 6, 8, 12 and 16 compared to Baseline

• Ability of Princess® RICH to improve skin elasticity

  Week 3, 6, 8, 12 and 16 compared to Baseline

• Subject satisfaction with treatment

  Week 8, 12 and 16

Other Outcomes (1)

• Ocurrence and frequency of adverse events

  Throughout the study (16 weeks)

Study Arms (1)

Princess® RICH

EXPERIMENTAL

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

Interventions

Princess® RICH DEVICE

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

Princess® RICH

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Croma-Pharma GmbH: lead

Study Sites (3)

MaRa-Medical Aesthetic Research Academy

Graz, Austria

Location

Medizinische Universität-Klinikum für Dermatologie und Venerologie

Graz, Austria

Location

YUVELL

Vienna, Austria

Location

Study Officials

• 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

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 8, 2019
• First Posted: April 22, 2019
• Study Start: October 16, 2018
• Primary Completion: April 29, 2019
• Study Completion: October 22, 2019
• Last Updated: December 10, 2024

Record last verified: 2024-12

Locations

AU (3)