NCT03050749CompletedNot Applicable
A Prospective, Open-label, Non-comparative, Multicentre, Post-market Clinical Follow-up Study of the Princess® VOLUME Performance and Safety for Correction of Facial Lipoatrophy, Morphological Asymmetry of the Face, or Debilitating Scars
Conditions
Interventions
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Croma-Pharma GmbH
- Enrollment
- 56
- Locations
- 3
- Primary Endpoint
- 6-point scale for clinical response
Study Overview
Brief 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® VOLUME, and then will return for follow-up assessments 2, 4, 24, and 36 weeks after the treatment. A touch-up treatment may be done 2 weeks after the treatment if deemed appropriate by the Investigator.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Other
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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 six 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
Arms & Interventions
Princess® VOLUME
Other
Intervention: Princess® VOLUME (Device)
Outcomes
Primary Outcomes
6-point scale for clinical response
Time Frame: 4 week
The proportion of patients with successful treatment outcome at the Week 4 visit based on the Investigator's opinion, where success is defined as excellent, good, or moderate correction of the defect
Secondary Outcomes
No secondary outcomes reported
Investigators
Study Sites (3)
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