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

Facial Lipoatrophy Clinical Trial

— 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03050749
• Other study ID #: CPH-401-201260
• Status: Completed
• Phase: N/A
• Start date: November 20, 2016
• Est. completion date: March 6, 2018

Study information

• Verified date: January 2018
• Source: Croma-Pharma GmbH
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 56
• Est. completion date: March 6, 2018
• Est. primary completion date: October 18, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

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

Intervention

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.

Locations

Country	Name	City	State
Austria	Medical University Graz	Graz
Austria	MÄZ WIEN Medizinisch Ästhetisches Zentrum Wien	Wien
Austria	Ordination Dr. Benjamin Gehl	Wien

Sponsors (1)

Lead Sponsor	Collaborator
Croma-Pharma GmbH

Country where clinical trial is conducted

Austria, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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