CompletedNot Applicable

Study to Evaluate the Effectiveness, Safety and Long Term Safety of Saypha® FILLER Lidocaine for Lip Augmentation

Austria114 participantsStarted 2020-07-28

Plain-language summary

This is a prospective, open-label, multicentre, randomized study conducted to evaluate the effectiveness, safety and long-term safety of Saypha® FILLER Lidocaine for lip augmentation.

Who can participate

Age range18 Years

SexALL

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Inclusion criteria

✓. Adult female or male subjects 18 years of age at Screening/Baseline visit (Visit 1)
✓. Presence of approximately symmetrical "very thin" lips (minimal red lip shows) to "moderately thick" lips (moderate red lip shows) as assessed with the LFS (severity grade of 1 to 3 on both lips) as determined by the investigator at Visit 1
✓. For females of childbearing potential only: negative urine pregnancy test at Visit 1, and must agree to use an highly effective method of contraception for the duration of the clinical investigation
✓. Healthy skin in the treatment area and free of diseases that could interfere in evaluation of treatment
✓. 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 this clinical investigation documented by a personally signed/dated informed consent.

Exclusion criteria

✕. Pregnancy, lactation, planned pregnancy or unwillingness to use contraception at any time during the study (for women of child-bearing potential only)
✕. History of mental disorders or emotional instability
✕. History of allergic reaction or hypersensitivity to hyaluronic acid, lidocaine or any amide-based anaesthetic
✕. Prior surgery, scars or tattoo to the upper or lower lip or lip line; surgery and tattooing are prohibited until end of clinical investigation
✕. Tooth gap, overbite, beard longer three-day beard, or excessive facial hair that could interfere in evaluation of treatment as judged by the investigator
✕. Presence of any abnormal lip structure, such as a scar or lump or severe lip asymmetry, as judged by the investigator
✕. Previous tissue augmenting therapy in the lip area (including lips, oral commissures, nasolabial folds, marionette and perioral lines) with HA or collagen filler, or laser treatment, chemical peeling, dermabrasion or mesotherapy within 12 months before Visit 1 and until end of clinical investigation
✕. Previous permanent implant or treatment with non-HA or non-collagen filler in the lip area (including lips, oral commissures, nasolabial folds, marionette and perioral lines) and until end of the investigation

What they're measuring

Responder Rate in Lip Volume Improvement

Timeframe: Week 6

Trial details

NCT IDNCT04917588

SponsorCroma-Pharma GmbH

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2020-12-14

Results submitted2024-12-18

View on ClinicalTrials.gov More Abnormal Lip trials