Princess® RICH for the Correction of Fine Lines

NCT ID: NCT03923634

Last Updated: 2024-12-10

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 102 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-10-16
• Study Completion Date: 2019-10-22

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

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

Princess® RICH

Intervention Type: DEVICE

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

Interventions

Princess® RICH

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

Intervention Type: DEVICE

Eligibility 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)

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Croma-Pharma GmbH

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Monika Sulovsky, MD

Role: PRINCIPAL_INVESTIGATOR

Yuvell

Daisy Kopera, MD

Role: PRINCIPAL_INVESTIGATOR

Medizinische Universität Graz- Klinikum für Dermatologie und Venerologie

Thomas Rappl, MD

Role: PRINCIPAL_INVESTIGATOR

MaRa-Medical Aesthetic Research Academy

Locations

MaRa-Medical Aesthetic Research Academy

Graz, , Austria

Medizinische Universität-Klinikum für Dermatologie und Venerologie

Graz, , Austria

YUVELL

Vienna, , Austria

Countries

Austria

Other Identifiers

CPH-401-201364

Identifier Type: -

Identifier Source: org_study_id