Lateral Canthal Lines (LCL)RICHERNCT07492277
A Non-Interventional PMCF Study Evaluating Croma Revitalis for the Correction of Fine Lines
An observational study of Lateral Canthal Lines (LCL) and Perioral Rhytids, run by Croma-Pharma GmbH at 1 site in Austria.
Trial summary
This study will serve to collect and analyze additional data on the use of the device croma revitalis for treatment of fine lines on the face including LCL and PR in the routine practice and as "real-world" performance. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Lateral Canthal Lines (LCL), Perioral Rhytids
- How many people
- 70 participants
- Where
- 1 siteAustria
- Study dates
- 16 Jan 2026to Sep 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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
- Healthy volunteers accepted
- Adult, Older adult
Study population: Adults seeking aesthetic treatment for fine lines, such as crow's feet and smile lines. Participants will be generally healthy and representative of typical dermal filler users in routine clinical practice.
Who may be able to join
- Participants deemed by the treating physician to have LCL and/or PR of sufficient severity to merit treatment with croma revitalis to be corrected and treatment decision is reached independent of this study.
- Male or female, 18 years of age or older at Visit 1 (Day 0).
- Healthy skin in the facial area and free of diseases that could interfere in cutaneous aging evaluation, based on the physician's judgment.
- Participants who, according to routine clinical advice, are willing to refrain from undergoing any aesthetic or surgical procedures in the treatment area during the observation period.
- Participants who understand the purpose and nature of the observational data documentation and willingness to participate in the routine follow-up after 3, 5, 8, 12, and 24 weeks as judged by the treating physician.
- Written signed and dated informed consent.
Who cannot join
- Participants who tend to develop hypertrophic scars, have pigment disorders, or have susceptibility to keloid formation.
- Participants with a history of autoimmune disease or who are receiving therapy for modification of immune response, e.g., biologics, systemic corticosteroids, cytostatic drugs (from Visit 1 [Day 0] until the end of the study).
- Participants who are known to be hypersensitive to components of the device as HA, glycerol, or gram-positive bacterial proteins.
- Participants who are pregnant or breast feeding.
- Participants who are anticoagulated or with history of bleeding disorder.
- Participants receiving daily treatment with platelet aggregation inhibitors (e.g., acetylsalicylic acid) unless previously cleared by their primary care physician.
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- Participants who have cutaneous, inflammatory, and/or infectious processes (e.g., acne, herpes) present at Visit 1 (Day 0), recurrent herpes simplex or (pre) cancerous lesions in the areas to be treated.
- Previous permanent implant or treatment with non-HA or non-collagen filler or non-absorbable sutures in the treatment area(s) any time prior to or planned during the observation period.
- Participants who have received dermabrasion, mesotherapy, chemical peeling, or micro-needling within 3 months prior first treatment and planned during the observation period.
- Participant has received any of the following (aesthetic) treatments in the treatment area within the last 12 months prior to the first routine treatment or planned during the observation period:
- Energy based device treatments that target collagen remodeling and/or production of collagen (e.g. laser therapy).
- Absorbable sutures (threads).
- HA or collagen dermal fillers.
- Botulinum toxin treatment.
- Facial lipolysis, including submental fat treatments.
- Facial plastic surgery.
- Bariatric surgery.
- Participants with uncontrolled (or unstable) systemic diseases as per the treating physician's discretion.
- Prior surgery, scars, or tattoos in the treatment area(s), that could interfere with clinical evaluation. Participants planning such procedures during the observation period will not be included.
- Beard, or facial hair that could interfere in evaluation of treatment as judged by the physician.
- Participants who have had or are planning to undergo bariatric surgery or facial plastic surgery in the area to be treated within less than 12 months before the first treatment in and planned during the observation period.
- Planned dental/oral surgery or modification (bridge-work, implants) within 4 weeks before the first treatment in and planned during the observation period.
- Current participation in another clinical study, or treatment with any investigational drug/MD/device within 30 days prior to the first treatment.
- Any medical condition or treatment potentially interfering with the clinical evaluation, according to the judgment of the treating physician.
- Participants whose participation in clinical trials is prohibited by the Austrian Medical Devices Act (MPG) (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
1 site in 1 country.
About this study
Official title: A Non-Interventional, Post-Market-Clinical-Follow up (PMCF), Prospective, Open-Label, Single-Center Observational Study Evaluating Croma Revitalis in Correction of Fine Lines
This study will serve to collect and analyze additional data on the use of the device croma revitalis for treatment of fine lines on the face including LCL and PR in the routine practice and as "real-world" performance.
Read the detailed description
This study is designed to observe the effects of croma revitalis, a medical device used to improve fine lines and skin quality, under real-life conditions. It is a prospective, open-label, non-comparative study, meaning all participants will receive the treatment, and both doctors and participants know what is being administered. This setup allows for efficient collection of clinical data while reflecting typical use in aesthetic practice. The study aims to evaluate improvements in skin concerns such as loss of volume, moisture, tone, and elasticity. The main way effectiveness will be measured is through the Global Aesthetic Improvement Scale (GAIS). This is a widely accepted 5-point scale used by doctors to assess visible improvements after treatment. The focus will be on improvements in areas such as lateral canthal lines (LCL), commonly known as "crow's feet", and perioral rhytides (PR), often referred to as "smile lines" or "smoker's lines." The primary evaluation point is Week 8, which is a typical follow-up period after a full treatment cycle consisting of three applications of the product. Participants will continue to be monitored until Week 24. The study plans to enroll approximately 70 participants, with the goal of collecting complete Week 8 data from at least 55 individuals.
- Conditions
- Lateral Canthal Lines (LCL), Perioral Rhytids
- Keywords
- Facial wrinkles, Fine lines, Crow's feet, Smile lines, Perioral rhytides, Lateral canthal lines, Dermal filler
What is being measured
The primary outcome is the main question the study is designed to answer.
Responder status at Week 8 after initial treatment.
Visible aesthetic changes at Week 8 after initial treatment in the treated fine lines of at least one treatment area (LCL and/or PR), compared to baseline, as assessed by the physician using the Global Aesthetic Improvement Scale (GAIS). The GAIS is a 5-point scale ranging from 1 (very much improved) to 5 (worse), where lower scores indicate greater aesthetic improvement.
Measured: 8 weeks after initial treatment
Secondary outcomes (7)
Responder Status Based on the Global Aesthetic Improvement Scale (GAIS) - Physician Assessment
Visible aesthetic changes at Weeks 3, 6, 12, and 24 after initial treatment compared to baseline, as assessed by the physician using the Global Aesthetic Improvement Scale (GAIS).
The GAIS is a 5-point scale ranging from 1 (very much improved) to 5 (worse), where lower scores indicate greater aesthetic improvement. Responders are defined as participants with a GAIS score of 1 (very much improved) or 2 (much improved).
Measured: Weeks 3, 6, 12, and 24 after initial treatment
Responder Status Based on the Global Aesthetic Improvement Scale (GAIS) - Independent Evaluator Panel
Visible aesthetic changes at Weeks 3, 6, 12, and 24 after initial treatment compared to baseline, as assessed by an independent evaluating panel using the Global Aesthetic Improvement Scale (GAIS).
The GAIS is a 5-point scale ranging from 1 (very much improved) to 5 (worse), where lower scores indicate greater aesthetic improvement. Responders are defined as participants with a GAIS score of 1 (very much improved) or 2 (much improved).
Measured: Weeks 3, 6, 12, and 24 after initial treatment
Change in Skin Hydration from Baseline Measured by Corneometer
Change in skin hydration compared to baseline measured using a Corneometer device, which quantifies skin hydration on the treated area(s). Higher values indicate greater skin hydration.
Measured: Week 3, 6, 8, 12, and 24
Change in Skin Tone from Baseline Measured by Cutometer
Change in skin tone compared to baseline measured on the treated area(s) using the Cutometer device.
Measured: Week 3, 6, 8, 12, and 24
Change in Skin Elasticity from Baseline Measured by Cutometer
Change in skin elasticity compared to baseline measured using a Cutometer device, which assesses the mechanical properties of the skin through suction-based deformation parameters.
Higher values indicate improved skin elasticity.
Measured: Week 3, 6, 8, 12, and 24
Participant Satisfaction with Treatment
Participant-reported satisfaction with treatment at each specified visit using a 5-point scale: "Very unsatisfied," "Unsatisfied," "Neither unsatisfied nor satisfied," "Satisfied," or "Very satisfied."
Measured: Week 8, 12, and 24
Aesthetic change based on the physician's live assessment
A live-assessment of the treated areas will be performed and the treated areas will be compared to the participant's photographs obtained at the baseline visit. The presence of the aesthetic change will be recorded as either "Yes" or "No".
Measured: Week 8, 12 an 24
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Mar 2026
- Study start16 Jan 2026
- Primary completion9 Jun 2026
- Study completionSep 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lateral Canthal Lines (LCL)Studies 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
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 70 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Croma-Pharma GmbH
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07492277
- Sponsor's protocol ID
- CPH-80501
- Acronym
- RICHER
- Status last verified
- Jul 2025
- First submitted
- 11 Mar 2026
- Last updated
- 28 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Non-Interventional, Post-Market-Clinical-Follow up (PMCF), Prospective, Open-Label, Single-Center Observational Study Evaluating Croma Revitalis in Correction of Fine Lines
- ClinicalTrials.gov ID
- NCT07492277
- Acronym / sponsor ID
- RICHER / CPH-80501
- Conditions
- Lateral Canthal Lines (LCL), Perioral Rhytids
- Keywords
- Facial wrinkles, Fine lines, Crow's feet, Smile lines, Perioral rhytides, Lateral canthal lines, Dermal filler
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 70 participants (estimated)
- Lead sponsor
- Croma-Pharma GmbHIndustry (pharma, biotech, devices)
- Study start
- 16 Jan 2026 (actual)
- Primary completion
- 9 Jun 2026 (actual)
- Study completion
- Sep 2026 (estimated)
- First posted
- 25 Mar 2026 (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.
This study will serve to collect and analyze additional data on the use of the device croma revitalis for treatment of fine lines on the face including LCL and PR in the routine practice and as "real-world" performance.
Detailed description
This study is designed to observe the effects of croma revitalis, a medical device used to improve fine lines and skin quality, under real-life conditions. It is a prospective, open-label, non-comparative study, meaning all participants will receive the treatment, and both doctors and participants know what is being administered. This setup allows for efficient collection of clinical data while reflecting typical use in aesthetic practice. The study aims to evaluate improvements in skin concerns such as loss of volume, moisture, tone, and elasticity. The main way effectiveness will be measured is through the Global Aesthetic Improvement Scale (GAIS). This is a widely accepted 5-point scale used by doctors to assess visible improvements after treatment. The focus will be on improvements in areas such as lateral canthal lines (LCL), commonly known as "crow's feet", and perioral rhytides (PR), often referred to as "smile lines" or "smoker's lines." The primary evaluation point is Week 8, which is a typical follow-up period after a full treatment cycle consisting of three applications of the product. Participants will continue to be monitored until Week 24. The study plans to enroll approximately 70 participants, with the goal of collecting complete Week 8 data from at least 55 individuals.
Study design
- Observational model
- Other
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Adults seeking aesthetic treatment for fine lines, such as crow's feet and smile lines. Participants will be generally healthy and representative of typical dermal filler users in routine clinical practice.
Key inclusion criteria (6 listed)
- Participants deemed by the treating physician to have LCL and/or PR of sufficient severity to merit treatment with croma revitalis to be corrected and treatment decision is reached independent of this study.
- Male or female, 18 years of age or older at Visit 1 (Day 0).
- Healthy skin in the facial area and free of diseases that could interfere in cutaneous aging evaluation, based on the physician's judgment.
- Participants who, according to routine clinical advice, are willing to refrain from undergoing any aesthetic or surgical procedures in the treatment area during the observation period.
- Participants who understand the purpose and nature of the observational data documentation and willingness to participate in the routine follow-up after 3, 5, 8, 12, and 24 weeks as judged by the treating physician.
Key exclusion criteria (25 listed)
- Participants who tend to develop hypertrophic scars, have pigment disorders, or have susceptibility to keloid formation.
- Participants with a history of autoimmune disease or who are receiving therapy for modification of immune response, e.g., biologics, systemic corticosteroids, cytostatic drugs (from Visit 1 [Day 0] until the end of the study).
- Participants who are known to be hypersensitive to components of the device as HA, glycerol, or gram-positive bacterial proteins.
- Participants who are pregnant or breast feeding.
- Participants who are anticoagulated or with history of bleeding disorder.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Responder status at Week 8 after initial treatment.
Time frame: 8 weeks after initial treatment
Visible aesthetic changes at Week 8 after initial treatment in the treated fine lines of at least one treatment area (LCL and/or PR), compared to baseline, as assessed by the physician using the Global Aesthetic Improvement Scale (GAIS). The GAIS is a 5-point scale ranging from 1 (very much improved) to 5 (worse), where lower scores indicate greater aesthetic improvement.
7 secondary outcomes
Responder Status Based on the Global Aesthetic Improvement Scale (GAIS) - Physician Assessment
Time frame: Weeks 3, 6, 12, and 24 after initial treatment
Responder Status Based on the Global Aesthetic Improvement Scale (GAIS) - Independent Evaluator Panel
Time frame: Weeks 3, 6, 12, and 24 after initial treatment
Change in Skin Hydration from Baseline Measured by Corneometer
Time frame: Week 3, 6, 8, 12, and 24
Change in Skin Tone from Baseline Measured by Cutometer
Time frame: Week 3, 6, 8, 12, and 24
Change in Skin Elasticity from Baseline Measured by Cutometer
Time frame: Week 3, 6, 8, 12, and 24
Participant Satisfaction with Treatment
Time frame: Week 8, 12, and 24
Aesthetic change based on the physician's live assessment
Time frame: Week 8, 12 an 24
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jul 2026.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Lateral Canthal Lines (LCL) and Perioral Rhytids, run by Croma-Pharma GmbH at 1 site 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 6 inclusion and 25 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: under way, not looking for participants, as of the sponsor's last update on 28 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
This study is still under way. Results are not available in the source record yet.
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?
Responder status at Week 8 after initial treatment. (time frame: 8 weeks after initial treatment). 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 28 Jul 2026.