CompletedNot Applicable

Effectiveness and Safety of Princess FILLER Lidocaine in Correction of Nasolabial Folds (NLF)

United States295 participantsStarted 2019-06-04

Plain-language summary

Clinical Investigation to demonstrate the effectiveness and safety of Princess Filler Lidocaine in the correction of moderate to severe nasolabial folds

Who can participate

Age range22 Years

SexALL

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Inclusion criteria

✓. Male or female subjects, 22 years of age or older, at the Screening visit
✓. Subjects with two fully visible, approximately symmetrical moderate to severe NLFs (same severity) with severity scores of 2 or 3 on the 5- point NLF-SRS for both NLF as judged by the treating investigator in conjunction with the independent blinded evaluating investigator.
✓. Females of childbearing potential must have a negative urine pregnancy test at injection visits and must agree to use an adequate method of contraception for the duration of the clinical investigation
✓. Healthy skin in the nasolabial area and free of diseases that could interfere in cutaneous aging evaluation
✓. Willingness to abstain from any aesthetic or surgical procedures in the treatment area for the duration of the clinical investigation, including botulinum toxin injections (except glabellar or forehead botulinum toxin treatment)
✓. Subjects having understood the purpose and conduct of the clinical investigation and having given written informed consent

Exclusion criteria

✕. For females: pregnant and/or lactating or planning to become pregnant during the clinical investigation
✕. History of allergies or hypersensitivity to HA preparations, lidocaine or anesthetics of any amide-based anesthetic
✕. Since Juvéderm® Ultra XC contains trace amounts of Gram-positive bacterial proteins, subjects with history of allergies to such material can not be included in this clinical investigation
✕. Tendency to keloid formation, hypertrophic scars and/or pigmentation disorders
✕. Known human immune deficiency virus-positive individuals
✕. Presence of infectious, inflammatory or proliferative cancerous or pre-cancerous lesions in the area to be treated
✕. Re-current herpes simplex in the treatment area
✕. History or presence of any autoimmune or connective tissue disease, or current treatment with immunomodulating therapy

What they're measuring

Responder Status Based on Independent Evaluating Investigator Live Assessment at Week 24 - Full Analysis Dataset

Timeframe: Week 24

Responder Status Based on Independent Evaluating Investigator Live Assessment at Week 24 - Per Protocol Dataset

Timeframe: Week 24

Trial details

NCT IDNCT03990883

SponsorCroma-Pharma GmbH

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2020-05-29

Results submitted2024-07-15

View on ClinicalTrials.gov More Dermatological Non-Disease trials