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. 2022 Jun 27;15:1157–1173. doi: 10.2147/CCID.S357810

Table 1.

Inclusion and Exclusion Criteria. The Study Was Conducted as a Multi-Center Study at Six Different Sites in Germany: Hamburg, Darmstadt, Potsdam, Kassel, Aachen and Oberursel

Inclusion Criteria
 ● No Botulinum toxin 6 months before enrolment in the study
 ● No treatments with low-viscoelastic HA in the last 12 months
 ● No treatments with high-viscoelastic HA in the last 24 months
 ● Provision of signed and dated informed consent form to participate in the study
Exclusion Criteria
 ● HIV, HBV and HCV, any acute infections (confirmed with high CRP)
 ● Severe skin diseases eg psoriasis, atopic eczema (neurodermatitis)
 ● Acne, active herpes zoster or autoimmune skin diseases in the face
 ● Skin cancer in the anamnesis
 ● Treatment with chemotherapy
 ● Immunosuppressive agents or immunomodulatory therapy (eg corticosteroids, monoclonal antibodies) within three months before study treatment
 ● Systemic diseases with skin involvement (eg SLE)
 ● Severe diet and/or nutritional supplementary in the last 3 months or the intention of these for the next 48 weeks
 ● Pregnancy or women who plan to become pregnant during the course of the study
 ● History of bleeding disorders or treatment with anticoagulants or inhibitors of platelet aggregation (eg ASS or other non-steroidal anti-inflammatory drugs [NSAIDs])
 ● Tendency to form keloids, hypertrophic scars or other healing disorder
 ● Any medical history that, in the opinion of the Investigator, would make the subject unsuitable for inclusion (eg chronic, relapsing or hereditary disease that may affect the outcome of the study).