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

NCT03990883 | Completed Results FDA Device

• 1 other identifier: CPH 301-201200F
• Study Type: interventional
• Target: 295
• Locations: 1 country
• Sites: 11

Brief Summary

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

Conditions

Dermatological Non-Disease

Keywords

nasolabial folds; correction

Outcome Measures

Primary Outcomes (2)

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

  The percentage of responders based on the independent blinded evaluating investigator live assessment at Week 24 after initial treatment and compared to Juvederm® Ultra XC. Responder is defined as having at least one grade improvement over Baseline, on the 5-point Nasolabial Folds-Severity Rating Scale (NLF-SRS). NLF-SRS scores are ranked as 0 (None/minimal), 1 (Mild), 2 (Moderate), 3 (Severe) and 4 (Extreme). Hierarchical Testing Procedure: This primary outcome measure is assessed first in a hierarchical testing sequence.

  Week 24

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

  The percentage of responders based on the independent blinded evaluating investigator live assessment at Week 24 after initial treatment and compared to Juvederm® Ultra XC. Responder is defined as having at least one grade improvement over Baseline, on the 5-point Nasolabial Folds-Severity Rating Scale (NLF-SRS). NLF-SRS scores are ranked as 0 (None/minimal), 1 (Mild), 2 (Moderate), 3 (Severe) and 4 (Extreme). Hierarchical Testing Procedure: This is the second outcome measure in the hierarchical testing sequence. Statistical significance for this measure will only be assessed if the first outcome measure achieves statistical significance at the predefined alpha level (0.025).

  Week 24

Secondary Outcomes (6)

• Responder Status Based on Independent Photographic Reviewers Assessment at Week 24 - Full Analysis Dataset

  Week 24

• Responder Status Based on Independent Photographic Reviewers Assessment at Week 24 - Per Protocol Dataset

  Week 24

• Responder Status Based on Treating Investigator Live Assessment at Week 24 - Full Analysis Set

  Week 24

• Responder Status Based on Treating Investigator Live Assessment at Week 24 - Per Protocol Set

  Week 24

• Improvement Over Baseline Based on Independent Blinded Evaluating Investigator Assessment at Week 24

  Week 24

Study Arms (2)

Treatment of device 1 on left side

OTHER

Treatment of nasolabial folds (NLF) with both Investigational Device and Comparator; Princess Filler Lidocaine is assigned to left NLF, Comparator is assigned to right NLF

Device: Princess Filler Lidocaine

Treatment of device 1 on right side

OTHER

Treatment of nasolabial folds (NLF) with both Investigational Device and Comparator; Princess Filler Lidocaine is assigned to right NLF, Comparator is assigned to left NLF

Device: Princess Filler Lidocaine

Interventions

Princess Filler Lidocaine DEVICE

correction of nasolabial folds

Treatment of device 1 on left side; Treatment of device 1 on right side

Eligibility Criteria

• Age: 22 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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

Sponsors & Collaborators

• Croma-Pharma GmbH: lead
• Syneos Health: collaborator

Study Sites (11)

Gary Monheit

Birmingham, Alabama, 35205, United States

Location

John Joseph

Beverly Hills, California, 91436, United States

Location

Sabrina Fabi

San Diego, California, 92121, United States

Location

Ava Shamban

Santa Monica, California, 90404, United States

Location

Joel Cohen

Greenwood Village, Colorado, 80111, United States

Location

Jeremy Green

Coral Gables, Florida, 33146, United States

Location

Robert Weiss

Hunt Valley, Maryland, 21030, United States

Location

Jeanine Downie

Montclair, New Jersey, 07042, United States

Location

The Center for Dermatology Cosmetic and Laser Surgery

New York, New York, 10549, United States

Location

Susan Taylor

Philadelphia, Pennsylvania, 19104, United States

Location

Michael Gold

Nashville, Tennessee, 37215, United States

Location

Results Point of Contact

• Title: Clinical Development - Head of Clinical Operations
• Organization: Croma Pharma GmbH

clinical.studies@croma.at

+43 2262 684680

Study Officials

• David Bank, MD

  Center of Dermatology, Cosmetic and Laser Surgery

  PRINCIPAL INVESTIGATOR

• Joel Cohen, MD

  AboutSkin research, LLC

  PRINCIPAL INVESTIGATOR

• John Joseph, MDE

  Dr. John Joseph Facial Plastic and Reconstructive Surgery

  PRINCIPAL INVESTIGATOR

• Gary Monheit, MD

  Total Skin and Beauty Dermatology Center

  PRINCIPAL INVESTIGATOR

• Ava Shamban, MD

  Ava MD

  PRINCIPAL INVESTIGATOR

• Susan Taylor, MD

  University of Pennsylvania

  PRINCIPAL INVESTIGATOR

• Robert Weiss, MD

  Maryland Laser Skin and Vein

  PRINCIPAL INVESTIGATOR

• Sabrina Fabi, MD

  Cosmetic, Lazer, Dermatology

  PRINCIPAL INVESTIGATOR

• Jeanine Downie, MD

  Image Dermatology P.C.

  PRINCIPAL INVESTIGATOR

• Jeremy Green, MD

  Skin Research Institute

  PRINCIPAL INVESTIGATOR

• Michael Gold, MD

  Tennesse Clinical Research Institute

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: subject- and evaluator-blinded
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Pivotal study

Study Record Dates

• First Submitted: June 17, 2019
• First Posted: June 19, 2019
• Study Start: June 4, 2019
• Primary Completion: May 29, 2020
• Study Completion: February 15, 2022
• Last Updated: February 4, 2025
• Results First Posted: February 4, 2025

Record last verified: 2024-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (11)