Princess® RICH for the Correction of Fine Lines

Lateral Canthal Lines Clinical Trial

— RICH  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03923634
• Other study ID #: CPH-401-201364
• Status: Completed
• Phase: N/A
• Start date: October 16, 2018
• Est. completion date: October 22, 2019

Study information

• Verified date: March 2021
• Source: Croma-Pharma GmbH
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 102
• Est. completion date: October 22, 2019
• Est. primary completion date: April 29, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Lateral Canthal Lines
• Perioral Rhytids

Intervention

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

Locations

Country	Name	City	State
Austria	MaRa-Medical Aesthetic Research Academy	Graz
Austria	Medizinische Universität-Klinikum für Dermatologie und Venerologie	Graz
Austria	YUVELL	Vienna

Sponsors (1)

Lead Sponsor	Collaborator
Croma-Pharma GmbH

Country where clinical trial is conducted

Austria, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Ocurrence and frequency of adverse events	Assessment of occurrence and frequency of adverse events	Throughout the study (16 weeks)
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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