Lateral Canthal LinesRICHNCT03923634
Princess® RICH for the Correction of Fine Lines
A study testing Princess® RICH in people with Lateral Canthal Lines and Perioral Rhytids, run by Croma-Pharma GmbH at 3 sites in Austria.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Lateral Canthal Lines, Perioral Rhytids
- What is being tested?
- Princess® RICH
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 102 participants
- Where
- 3 sitesAustria
- Study dates
- 16 Oct 2018to 22 Oct 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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.
Show all 12Show fewer
- 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)
Trial locations and contacts
3 sites in 1 country.
Austria3 sites
MaRa-Medical Aesthetic Research Academy
Graz
Medizinische Universität-Klinikum für Dermatologie und Venerologie
Graz
YUVELL
Vienna
About this study
Official title: A Prospective Open-label, Multicenter Study Evaluating Princess® RICH in 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.
- Conditions
- Lateral Canthal Lines, Perioral Rhytids
- Being tested
- Princess® RICH
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Princess® RICHDevice
Princess® RICH is injected into lateral canthal lines and/or perioral rhytids
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Device: Princess® RICH |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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)
Percentage of responders at week 12 and 16.
Measured: Week 12 and 16 compared to Baseline
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.
Measured: Week 3, 6, 8, 12 and 16 compared to Baseline
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.
Measured: Week 3, 6, 8, 12 and 16 compared to Baseline
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.
Measured: Week 3, 6, 8, 12 and 16 compared to Baseline
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".
Measured: Week 8, 12 and 16
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Apr 2019
- Study start16 Oct 2018
- Primary completion29 Apr 2019
- Study completion22 Oct 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lateral Canthal LinesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 102 participants (actual)
Sponsor and investigators
- Lead sponsor
- Croma-Pharma GmbH
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Monika Sulovsky, MD, Principal investigator, YuvellDaisy Kopera, MD, Principal investigator, Medizinische Universität Graz- Klinikum für Dermatologie und VenerologieThomas Rappl, MD, Principal investigator, MaRa-Medical Aesthetic Research Academy
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03923634
- Sponsor's protocol ID
- CPH-401-201364
- Acronym
- RICH
- Status last verified
- Dec 2024
- First submitted
- 8 Apr 2019
- Last updated
- 10 Dec 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective Open-label, Multicenter Study Evaluating Princess® RICH in Correction of Fine Lines
- ClinicalTrials.gov ID
- NCT03923634
- Acronym / sponsor ID
- RICH / CPH-401-201364
- Conditions
- Lateral Canthal Lines, Perioral Rhytids
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 102 participants (actual)
- Lead sponsor
- Croma-Pharma GmbHIndustry (pharma, biotech, devices)
- Study start
- 16 Oct 2018 (actual)
- Primary completion
- 29 Apr 2019 (actual)
- Study completion
- 22 Oct 2019 (actual)
- First posted
- 22 Apr 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Princess® RICH | Experimental | Device: Princess® RICHEligible 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (12 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Princess® RICHPrincess® RICH is injected into lateral canthal lines and/or perioral rhytids | Device | Princess® RICH |
Primary outcome
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
5 secondary outcomes
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
Ability of Princess® RICH to improve skin hydration
Time frame: Week 3, 6, 8, 12 and 16 compared to Baseline
Ability of Princess® RICH to improve skin tone
Time frame: Week 3, 6, 8, 12 and 16 compared to Baseline
Ability of Princess® RICH to improve skin elasticity
Time frame: Week 3, 6, 8, 12 and 16 compared to Baseline
Subject satisfaction with treatment
Time frame: Week 8, 12 and 16
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Dec 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Monika Sulovsky, MD principal investigator
Yuvell
Daisy Kopera, MD principal investigator
Medizinische Universität Graz- Klinikum für Dermatologie und Venerologie
Thomas Rappl, MD principal investigator
MaRa-Medical Aesthetic Research Academy
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Princess® RICH in people with Lateral Canthal Lines and Perioral Rhytids, run by Croma-Pharma GmbH at 3 sites in Austria.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Austria. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Dec 2024.