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

NCT03050749 | Completed

• 1 other identifier: CPH-401-201260
• Study Type: interventional
• Target: 56
• Locations: 1 country
• Sites: 3

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.

Conditions

Facial Lipoatrophy; Morphological Asymmetry of the Face; Debilitating Scars

Outcome Measures

Primary Outcomes (1)

• 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

  4 week

Study Arms (1)

Princess® VOLUME

OTHER

Device: Princess® VOLUME

Interventions

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.

Princess® VOLUME

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Croma-Pharma GmbH: lead

Study Sites (3)

Medical University Graz

Graz, Austria

Location

MÄZ WIEN Medizinisch Ästhetisches Zentrum Wien

Vienna, Austria

Location

Ordination Dr. Benjamin Gehl

Vienna, Austria

Location

Study Officials

• Daisy Kopera, Prof.

  Medical University Graz, Austria

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Princess® VOLUME

Study Record Dates

• First Submitted: February 9, 2017
• First Posted: February 13, 2017
• Study Start: November 20, 2016
• Primary Completion: October 18, 2017
• Study Completion: March 6, 2018
• Last Updated: December 9, 2024

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will not share

Locations

AU (3)