Safety and Performance of Princess® FILLER for the Treatment of Facial Lipoatrophy, Asymmetry or … (NCT03050723) | Clinical Trial Compass
CompletedNot Applicable
Safety and Performance of Princess® FILLER for the Treatment of Facial Lipoatrophy, Asymmetry or Scars
Austria53 participantsStarted 2016-11-20
Plain-language summary
In this study, eligible patients with the medical indications (facial lipoatrophy, morphological asymmetry of the face, or debilitating scars) will be treated with Princess® FILLER, and then will return for follow-up assessments 2, 4 and 24 weeks after the treatment. A touch-up treatment may be done 2 weeks after the treatment.
Who can participate
Age range18 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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 withi…