NCT07492277

A Non-Interventional PMCF Study Evaluating Croma Revitalis for the Correction of Fine Lines

A Non-Interventional, Post-Market-Clinical-Follow up (PMCF), Prospective, Open-Label, Single-Center Observational Study Evaluating Croma Revitalis in Correction of Fine Lines

• Status: Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 70 (estimated)
• Sponsor: Croma-Pharma GmbH · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

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.

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

Timeline

• Start date: 2026-01-16
• Primary completion: 2026-07-15
• Completion: 2026-11-15
• First posted: 2026-03-25
• Last updated: 2026-03-25

Locations

1 site across 1 country: Austria