Clinical trial NCT03923634: Princess® RICH for the Correction of Fine Lines
Official title: A Prospective Open-label, Multicenter Study Evaluating Princess® RICH in Correction of Fine Lines
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Lateral Canthal Lines
Perioral Rhytids
Lead sponsor: Croma-Pharma GmbH
Sponsor class: INDUSTRY
First posted: 2019-04-22
Enrollment: 102
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

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.


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)

Primary outcomes:
measure: Effectiveness of Princess® RICH to correct fine lines on the face including lateral canthal lines (LCL) and perioral rhytids (PR)
timeFrame: Week 8 compared to Baseline
Secondary outcomes:
measure: Effectiveness of Princess® RICH to correct fine lines on the face including lateral canthal lines (LCL) and perioral rhytids (PR)
timeFrame: Week 12 and 16 compared to Baseline
measure: Ability of Princess® RICH to improve skin hydration
timeFrame: Week 3, 6, 8, 12 and 16 compared to Baseline
measure: Ability of Princess® RICH to improve skin tone
timeFrame: Week 3, 6, 8, 12 and 16 compared to Baseline
measure: Ability of Princess® RICH to improve skin elasticity
timeFrame: Week 3, 6, 8, 12 and 16 compared to Baseline
measure: Subject satisfaction with treatment
timeFrame: Week 8, 12 and 16
Other outcomes:
measure: Ocurrence and frequency of adverse events
timeFrame: Throughout the study (16 weeks)
Locations:
city: Graz
country: Austria
facility: MaRa-Medical Aesthetic Research Academy
city: Graz
country: Austria
facility: Medizinische Universität-Klinikum für Dermatologie und Venerologie
city: Vienna
country: Austria
facility: YUVELL
Study officials:
affiliation: Yuvell
name: Monika Sulovsky, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Medizinische Universität Graz- Klinikum für Dermatologie und Venerologie
name: Daisy Kopera, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: MaRa-Medical Aesthetic Research Academy
name: Thomas Rappl, MD
role: PRINCIPAL_INVESTIGATOR
References: