Actively Recruiting
A Non-Interventional PMCF Study Evaluating Croma Revitalis for the Correction of Fine Lines
Led by Croma-Pharma GmbH · Updated on 2026-03-25
70
Participants Needed
1
Research Sites
43 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
A Non-Interventional PMCF Study Evaluating Croma Revitalis for the Correction of Fine Lines
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Participants with lateral canthal lines and/or perioral rhytides severe enough to be treated with Croma Revitalis as decided by their physician
- Male or female aged 18 years or older at the first visit
- Healthy facial skin without diseases that could affect skin aging evaluation
- Willingness to avoid other aesthetic or surgical procedures in the treatment area during the study
- Willingness to participate in routine follow-ups at Weeks 3, 5, 8, 12, and 24
- Signed informed consent
You will not qualify if you...
- History or tendency for hypertrophic scars, pigment disorders, or keloid formation
- History of autoimmune disease or current immune-modifying therapy (e.g., biologics, corticosteroids, cytostatic drugs)
- Known allergy to components of the device such as hyaluronic acid, glycerol, or bacterial proteins
- Pregnant or breastfeeding
- Anticoagulation therapy or bleeding disorders
- Daily use of platelet aggregation inhibitors unless cleared by a doctor
- Presence of active skin inflammation, infection, recurrent herpes, or pre-cancerous lesions in the treatment area
- Previous permanent implants, non-HA/non-collagen fillers, or non-absorbable sutures in the treatment area
- Dermabrasion, mesotherapy, chemical peeling, or micro-needling within 3 months before treatment
- Aesthetic procedures targeting collagen or involving fillers, surgery, or lipolysis in the past 12 months
- Uncontrolled systemic diseases
- Scars or tattoos in the treatment area that interfere with evaluation
- Facial hair interfering with evaluation
- Planned bariatric or facial plastic surgery or dental/oral surgery near treatment time
- Participation in another clinical study or investigational treatment within 30 days before treatment
- Any medical condition or treatment that might interfere with clinical evaluation
- Persons legally prohibited from clinical trial participation under Austrian Medical Devices Act
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Yuvell
Vienna, Austria, 1010
Actively Recruiting
Research Team
H
Head of Clinical Operations
CONTACT
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
0
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