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

• Register: ClinicalTrials.gov
• Last refreshed on: 12 December 2020
• Main ID: NCT03050723
• Date of registration: 09/02/2017
• Prospective Registration: No
• Primary sponsor: Croma-Pharma GmbH
• Public title: Safety and Performance of Princess® FILLER for the Treatment of Facial Lipoatrophy, Asymmetry or Scars FLASH 1
• Scientific title: A Prospective, Open-label, Non-comparative, Multicentre, Post-market Clinical Follow-up Study of the Princess® FILLER Performance and Safety for Correction of Facial Lipoatrophy, Morphological Asymmetry of the Face, or Debilitating Scars
• Date of first enrolment: November 20, 2016
• Target sample size: 53
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT03050723
• Study type: Interventional
• Study design: Allocation: N/A. Intervention model: Single Group Assignment. Primary purpose: Other. Masking: None (Open Label).
• Phase: N/A

Countries of recruitment

Austria

Contacts

• Name: Daisy Kopera, Prof.
• Affiliation: Medical University Graz, Austria

Key inclusion & exclusion 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 6 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



Age minimum: 18 Years
Age maximum: N/A
Gender: All

Health Condition(s) or Problem(s) studied

Facial Lipoatrophy

Morphological Asymmetry of the Face

Debilitating Scars

Intervention(s)

Device: Princess® FILLER

Primary Outcome(s)

6-point scale for clinical response [Time Frame: Week 4]

Secondary ID(s)

CPH-401-201259

Source(s) of Monetary Support

Please refer to primary and secondary sponsors