Safety and Performance of Princess® FILLER for the Treatment of Facial Lipoatrophy, Asymmetry or Scars

Launched by CROMA-PHARMA GMBH · Feb 9, 2017

Keywords

ClinConnect Summary

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Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • Male or female 18 years of age or older.
• • Presence of a defect, which in the opinion of the Investigator can be corrected by a dermal filler, and is caused by: ° Facial lipoatrophy of moderate severity, or
• • Morphological asymmetry of the face, or
• • One or more debilitating scars on the face.
• • Willingness to abstain from any cosmetic or surgical procedures in the treatment area for the duration of the clinical investigation.
• • Willingness to take part in the clinical investigation as evidenced by a personally signed informed consent.
• Exclusion Criteria:
• • Pregnancy, breastfeeding, or unwillingness to use contraception throughout the clinical investigation (for women of child-bearing potential only).
• • History of allergic reaction or hypersensitivity to hyaluronic acid.
• • History or presence of any autoimmune or connective tissue disease, or current treatment with immune therapy.
• • Presence of silicone implant or other non-absorbable tissue filler in the area targeted for intervention, or pre-treatment with any hyaluronic acid filler within the last 6 months.
• • Presence of infectious, inflammatory, or proliferative lesions in the area targeted for intervention.
• • Treatment with anticoagulant or antiplatelet drugs
• • Any disease or condition which, in the Investigator's opinion, represents a safety risk for participation in the study
• • Current participation in another clinical trial, or previous treatment with any investigational drug/device within 30 days prior to enrolment
• • Institutionalized persons with legally limited civil rights