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

Not Applicable

Completed

• Conditions: Morphological Asymmetry of the Face; Debilitating Scars; Facial Lipoatrophy
• Interventions: Device: Princess® VOLUME

• Registration Number: NCT03050749
• Lead Sponsor: Croma-Pharma GmbH

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2016-11-20
• Study First Submitted: 2017-02-09
• Study First Submitted QC: 2017-02-09
• Study First Posted: 2017-02-13
• Primary Completion: 2017-10-18
• Study Completion: 2018-03-06
• Status Verified: 2024-12
• Last Update Submitted: 2024-12-06
• Last Update Posted: 2024-12-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 56

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Princess® VOLUME	Princess® VOLUME	-

Primary Outcome Measures

Name	Time	Method
6-point scale for clinical response	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

Trial Locations

Locations (3)

MÄZ WIEN Medizinisch Ästhetisches Zentrum Wien; 🇦🇹 Wien, Austria

Ordination Dr. Benjamin Gehl; 🇦🇹 Wien, Austria

Medical University Graz; 🇦🇹 Graz, Austria