Safety and Performance of Princess® FILLER for the Treatment of Facial Lipoatrophy, Asymmetry or Scars (FLASH 1)
Primary Purpose
Facial Lipoatrophy, Morphological Asymmetry of the Face, Debilitating Scars
Status
Completed
Phase
Not Applicable
Locations
Austria
Study Type
Interventional
Intervention
Princess® FILLER
Sponsored by
About this trial
This is an interventional other trial for Facial Lipoatrophy
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
Sites / Locations
- Medical University Graz
- MÄZ WIEN (Medizinisch Ästhetisches Zentrum Wien)
- Ordination Dr. Benjamin Gehl
Arms of the Study
Arm 1
Arm Type
Other
Arm Label
Princess® FILLER
Arm Description
Outcomes
Primary Outcome Measures
6-point scale for clinical response
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 Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03050723
Brief Title
Safety and Performance of Princess® FILLER for the Treatment of Facial Lipoatrophy, Asymmetry or Scars
Acronym
FLASH 1
Official Title
A Prospective, Open-label, Non-comparative, Multicentre, Post-market Clinical Follow-up Study of the Princess® FILLER Performance and Safety for Correction of Facial Lipoatrophy, Morphological Asymmetry of the Face, or Debilitating Scars
Study Type
Interventional
2. Study Status
Record Verification Date
January 2018
Overall Recruitment Status
Completed
Study Start Date
November 20, 2016 (Actual)
Primary Completion Date
July 17, 2017 (Actual)
Study Completion Date
January 16, 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Croma-Pharma GmbH
4. Oversight
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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® 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Facial Lipoatrophy, Morphological Asymmetry of the Face, Debilitating Scars
7. Study Design
Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
Princess® FILLER
Masking
None (Open Label)
Allocation
N/A
Enrollment
53 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Princess® FILLER
Arm Type
Other
Intervention Type
Device
Intervention Name(s)
Princess® FILLER
Intervention Description
Princess® FILLER injections up to 10 ml applied to the eligible subjects at the baseline visit, and the touch-up visit, if applicable.
Primary Outcome Measure Information:
Title
6-point scale for clinical response
Description
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
Time Frame
Week 4
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Daisy Kopera, Prof.
Organizational Affiliation
Medical University Graz, Austria
Official's Role
Principal Investigator
Facility Information:
Facility Name
Medical University Graz
City
Graz
Country
Austria
Facility Name
MÄZ WIEN (Medizinisch Ästhetisches Zentrum Wien)
City
Wien
Country
Austria
Facility Name
Ordination Dr. Benjamin Gehl
City
Wien
Country
Austria
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Safety and Performance of Princess® FILLER for the Treatment of Facial Lipoatrophy, Asymmetry or Scars
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