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

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

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.

Study Overview

• Status: Completed
• Conditions: Facial Lipoatrophy; Morphological Asymmetry of the Face; Debilitating Scars
• Intervention / Treatment: Device: Princess® FILLER

• Study Type: Interventional
• Enrollment (Actual): 53
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Austria
  • Graz, Austria
    • Medical University Graz
  • Wien, Austria
    • Ordination Dr. Benjamin Gehl
  • Wien, Austria
    • MÄZ WIEN (Medizinisch Ästhetisches Zentrum Wien)

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	Week 4

Collaborators and Investigators

• Sponsor: Croma-Pharma GmbH
• Investigators: Principal Investigator: Daisy Kopera, Prof., Medical University Graz, Austria

Study record dates

Study Major Dates

• Study Start (Actual): November 20, 2016
• Primary Completion (Actual): July 17, 2017
• Study Completion (Actual): January 16, 2018

Study Registration Dates

• First Submitted: February 9, 2017
• First Submitted That Met QC Criteria: February 9, 2017
• First Posted (Actual): February 13, 2017

Study Record Updates

• Last Update Posted (Actual): December 9, 2024
• Last Update Submitted That Met QC Criteria: December 6, 2024
• Last Verified: December 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Disease Attributes; Metabolic Diseases; Skin Diseases; Lipid Metabolism Disorders; Skin Diseases, Metabolic; Facies; Lipodystrophy
• Other Study ID Numbers: CPH-401-201259

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated device product: No