Clinical trial NCT03050749: Safety and Performance of Princess® VOLUME for the Treatment of Facial Lipoatrophy, Asymmetry or Scars
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Facial Lipoatrophy
Morphological Asymmetry of the Face
Debilitating Scars
Lead sponsor: Croma-Pharma GmbH
Sponsor class: INDUSTRY
First posted: 2017-02-13
Enrollment: 56
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Princess® VOLUME
Primary purpose: OTHER

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.


Eligibility criteria: 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

Primary outcomes:
measure: 6-point scale for clinical response
timeFrame: 4 week
Secondary outcomes:
Other outcomes:
Locations:
city: Graz
country: Austria
facility: Medical University Graz
city: Wien
country: Austria
facility: MÄZ WIEN Medizinisch Ästhetisches Zentrum Wien
city: Wien
country: Austria
facility: Ordination Dr. Benjamin Gehl
Study officials:
affiliation: Medical University Graz, Austria
name: Daisy Kopera, Prof.
role: PRINCIPAL_INVESTIGATOR
References: