Safety and Performance of Princess® FILLER for the Treatment of Facial Lipoatrophy, Asymmetry or Scars (FLASH 1)
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The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
ClinicalTrials.gov Identifier: NCT03050723 |
Recruitment Status :
Completed
First Posted : February 13, 2017
Last Update Posted : January 25, 2018
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Facial Lipoatrophy Morphological Asymmetry of the Face Debilitating Scars | Device: Princess® FILLER | Not Applicable |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 53 participants |
Allocation: | N/A |
Intervention Model: | Single Group Assignment |
Intervention Model Description: | Princess® FILLER |
Masking: | None (Open Label) |
Primary Purpose: | Other |
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 |
Actual Study Start Date : | November 20, 2016 |
Actual Primary Completion Date : | July 17, 2017 |
Actual Study Completion Date : | January 16, 2018 |
Arm | Intervention/treatment |
---|---|
Princess® FILLER |
Device: Princess® FILLER
Princess® FILLER injections up to 10 ml applied to the eligible subjects at the baseline visit, and the touch-up visit, if applicable. |
- 6-point scale for clinical response [ Time Frame: Week 4 ]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

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Male or female 18 years of age or older.
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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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03050723
Austria | |
Medical University Graz | |
Graz, Austria | |
MÄZ WIEN (Medizinisch Ästhetisches Zentrum Wien) | |
Wien, Austria | |
Ordination Dr. Benjamin Gehl | |
Wien, Austria |
Principal Investigator: | Daisy Kopera, Prof. | Medical University Graz, Austria |
Responsible Party: | Croma-Pharma GmbH |
ClinicalTrials.gov Identifier: | NCT03050723 |
Other Study ID Numbers: |
CPH-401-201259 |
First Posted: | February 13, 2017 Key Record Dates |
Last Update Posted: | January 25, 2018 |
Last Verified: | January 2018 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | No |
Studies a U.S. FDA-regulated Device Product: | No |
Lipodystrophy Facies Pathologic Processes Disease Attributes |
Skin Diseases, Metabolic Skin Diseases Lipid Metabolism Disorders Metabolic Diseases |