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Safety and Performance of Princess® VOLUME for the Treatment of Facial Lipoatrophy, Asymmetry or Scars (FLASH2)

Primary Purpose

Facial Lipoatrophy, Morphological Asymmetry of the Face, Debilitating Scars

Status

Completed

Phase

Not Applicable

Locations

Austria

Study Type

Interventional

Intervention

Princess® VOLUME

About this trial

This is an interventional other trial for Facial Lipoatrophy

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

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® VOLUME

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

NCT ID

NCT03050749

First Posted

February 9, 2017

Last Updated

February 24, 2019

Sponsor

Croma-Pharma GmbH

1. Study Identification

Unique Protocol Identification Number

NCT03050749

Brief Title

Safety and Performance of Princess® VOLUME for the Treatment of Facial Lipoatrophy, Asymmetry or Scars

Acronym

FLASH2

Official Title

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

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

October 18, 2017 (Actual)

Study Completion Date

March 6, 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 Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

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® 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.

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® VOLUME

Masking

None (Open Label)

Allocation

N/A

Enrollment

56 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Princess® VOLUME

Arm Type

Other

Intervention Type

Device

Intervention Name(s)

Princess® VOLUME

Intervention Description

Princess® VOLUME 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

4 week

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

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 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

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

Learn more about this trial

Safety and Performance of Princess® VOLUME for the Treatment of Facial Lipoatrophy, Asymmetry or Scars

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