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

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Facial Lipoatrophy Debilitating Scars Morphological Asymmetry of the Face

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Medical University Graz, Graz, Austria

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Princess® VOLUME

Device

Princess® VOLUME injections up to 10 ml applied to the eligible subjects at the baseline visit, and the touch-up visit, if applicable.

Primary outcomes

6-point scale for clinical response

Time frame: 4 week

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

Sponsors and collaborators

Lead sponsor

Croma-Pharma GmbH

Industry

Registry information

Official study 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

Acronym: FLASH2

Important dates

Study start: 2016
Primary completion: 2017
Study completion: 2018
First posted: Feb 13, 2017
Registry last updated: Dec 9, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed