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

NCT03050749 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 56

Last updated 2024-12-09

No results posted yet for this study

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.

Conditions

  • Facial Lipoatrophy
  • Morphological Asymmetry of the Face
  • Debilitating Scars

Interventions

DEVICE

Princess® VOLUME

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

Sponsors & Collaborators

  • Croma-Pharma GmbH

    lead INDUSTRY

Principal Investigators

  • Daisy Kopera, Prof. · Medical University Graz, Austria

Study Design

Allocation
NA
Purpose
OTHER
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-11-20
Primary Completion
2017-10-18
Completion
2018-03-06

Countries

  • Austria

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03050749 on ClinicalTrials.gov