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Safety and Performance of Princess® FILLER for the Treatment of Facial Lipoatrophy, Asymmetry or Scars (FLASH 1)

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
Sponsor:
Information provided by (Responsible Party):
Croma-Pharma GmbH

Study Description
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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.

Condition or disease Intervention/treatment Phase
Facial Lipoatrophy Morphological Asymmetry of the Face Debilitating Scars Device: Princess® FILLER Not Applicable

Study Design
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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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Scars

Arms and Interventions
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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.


Outcome Measures
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Primary Outcome Measures :
  1. 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


Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations
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Information from the National Library of Medicine

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


Locations
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Austria
Medical University Graz
Graz, Austria
MÄZ WIEN (Medizinisch Ästhetisches Zentrum Wien)
Wien, Austria
Ordination Dr. Benjamin Gehl
Wien, Austria
Sponsors and Collaborators
Croma-Pharma GmbH
Investigators
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Principal Investigator: Daisy Kopera, Prof. Medical University Graz, Austria
More Information
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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

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Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Lipodystrophy
Facies
Pathologic Processes
Disease Attributes
 Skin Diseases, Metabolic
Skin Diseases
Lipid Metabolism Disorders
Metabolic Diseases