Safety and Performance of Princess® VOLUME for the Treatment of Facial Lipoatrophy, Asymmetry or Scars (FLASH2)

Croma-Pharma

Status: Completed

Conditions: Debilitating Scars; Facial Lipoatrophy; Morphological Asymmetry of the Face

Treatments: Device: Princess® VOLUME

Study type: Interventional

Funder types: Industry

Identifiers

NCT03050749

CPH-401-201260

Details and patient eligibility

About

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.

Enrollment: 56 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Other

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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56 participants in 1 patient group

Princess® VOLUME

Other group

Treatment:

Device: Princess® VOLUME