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

Exclusion Criteria25

• 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.
• 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).