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.
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 Type
OBSERVATIONAL
Enrollment
70
Yuvell
Vienna, Austria
RECRUITINGResponder 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.
Time frame: 8 weeks after initial treatment
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).
Time frame: 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).
Time frame: 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.
Time frame: Week 3, 6, 8, 12, and 24
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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.
Time frame: 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.
Time frame: 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."
Time frame: 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".
Time frame: Week 8, 12 an 24