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

Completed · Not applicable

Conditions studied: Dermatological Non-Disease

In brief

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

Key facts

Study ID: NCT03990883
Run by: Croma-Pharma GmbH
People needed: 295
Starts: 2019-06-04
Expected to finish: 2022-02-15
Last updated by the study team: 2025-02-04

Who can join

Age: 22 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

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

You may not qualify if…

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
Uncontrolled (or instable) diabetes mellitus or systemic diseases
Facial plastic surgery, tissue augmentation with silicone, fat or another non-absorbable substance (permanent fillers) area of device application
Implantation of facial dermal fillers in the treatment area in the preceding twelve months
Skin of the nasolabial region affected by aesthetic treatments (e.g. laser therapy, absorbable and non-absorbable sutures (threads), microneedling and/or botulinum toxin within the last twelve months, dermabrasion and mesotherapy within the last six months, chemical peeling within the last three months) or planning to undergo such procedures during the clinical investigation
Facial lypolysis, including submental fat treatments, within last month prior to enrollment and during the clinical investigation
Bariatric surgery within 12 months prior to enrollement and during the clinical investigation
History of bleeding disorders and/or use of anticoagulant, antiplatelet or thrombolytic medication from ten days pre- to three days post injection
Planned dental/oral surgery or modification (bridge-work, implants) within two weeks prior injection and to a minimum of four weeks post injection
Any medical condition prohibiting the inclusion in the clinical investigation according to the judgment of the treating investigator
Previous enrollment in this clinical investigation
Current participation in another clinical investigation, or treatment with any investigational drug/medical device within 30 days prior to clinical investigation enrollment
Any dependency of the subject to the treating investigator, the blinded independent evaluating investigator or clinical investigation site (e.g. employees of the sponsor), or subjects who are employees or relatives of the treating investigator and/or the independent blinded evaluating investigator
Subjects who have one of the following assessments during the visual examinations at Baseline:
Snellen visual acuity test worse than 20/40 (with corrective eyewear, if applicable), abnormal confrontational visual field test, or abnormal ocular motility test.
Repeat Treatment - Inclusion Criteria:
In the opinion of the treating investigator, the subject has returned to sufficient severity of both NLFs that would have qualified him for enrollment into the clinical investigation initially (note that the subject does not have to return to his Baseline severity to be permitted to receive a repeat treatment)
Subjects with NLFs with severity scores of 2 or 3 on the 5-point NLF-SRS for both NLFs as judged by the treating investigator in conjunction with the independent blinded evaluating investigator (note that it is not necessary for the treating and evaluating investigator to agree on the same rating)

Where it is running

Gary Monheit — Birmingham, Alabama, United States
John Joseph — Beverly Hills, California, United States
Sabrina Fabi — San Diego, California, United States
Ava Shamban — Santa Monica, California, United States
Joel Cohen — Greenwood Village, Colorado, United States
Jeremy Green — Coral Gables, Florida, United States
Robert Weiss — Hunt Valley, Maryland, United States
Jeanine Downie — Montclair, New Jersey, United States
The Center for Dermatology Cosmetic and Laser Surgery — New York, New York, United States
Susan Taylor — Philadelphia, Pennsylvania, United States
Michael Gold — Nashville, Tennessee, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.