CompletedNot Applicable

A 52-week Clinical Investigation of Princess® VOLUME PLUS Lidocaine in Subjects With Midface Volume Deficit

Austria, Germany91 participantsStarted 2018-03-28

Plain-language summary

This investigation aims to confirm the safety and effectiveness of Princess VOLUME PLUS Lidocaine in midface volume deficit augmentation and includes a long term safety followup.

Who can participate

Age range18 Years

SexALL

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Inclusion criteria

✓. Male or female, 18 years of age or older;
✓. Presence of bilateral, approximately symmetric moderate to severe midface volume deficit, corresponding to MVDSS grades 2-3;
✓. A negative urine pregnancy test at Visit 1 and commitment to use an adequate method of birth control for the duration of the clinical investigation (for women of childbearing potential only);
✓. Healthy skin in the midface area and free of diseases that could interfere with evaluation of cutaneous aging or represent a risk for injection;
✓. Willingness to abstain from any other aesthetic or surgical procedures in the treatment area for the duration of the investigation, including botulinum toxin injections (except glabella or forehead botulinum toxin treatment);
✓. Capable to understand information about the investigation, including subjects' obligations, and is willing to take part, as evidenced by signed and dated informed consent.

Exclusion criteria

✕. Presence or history of hypertrophic scarring, pigment disorders or keloid formation.
✕. Presence or history of any autoimmune disease or current treatment with immune therapy.
✕. History of hypersensitivity to hyaluronic acid, lidocaine hydrochloride or other amide-type local anaesthetics.
✕. Previous treatment with a permanent filler in the area to be treated.
✕. Pregnant or breastfeeding women.
✕. Treatment with anticoagulants and platelet aggregation inhibitors (e.g., acetylsalicylic acid) within 10 days prior to Visit 1, unless the risk of bleeding/bruising is discharged after consultation with subject's physician who had prescribed such medicine.
✕. Cutaneous, inflammatory and/or infectious processes (e.g., acne, herpes) in the area to be treated.
✕. Laser therapy, dermabrasion or mesotherapy within 12 months, or chemical peeling within 3 months prior to Visit 1.

What they're measuring

Primary performance endpoint

Timeframe: 4 weeks

Trial details

NCT IDNCT03532126

SponsorCroma-Pharma GmbH

Sponsor typeINDUSTRY

Study typeOBSERVATIONAL

Primary completion2019-07-24

View on ClinicalTrials.gov More Midface Volume Deficit trials