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

A Randomized, Subject- and Evaluating Investigator-blinded, Controlled, Multicenter, Split-face, Comparison Clinical Investigation to Evaluate Effectiveness and Safety of Princess FILLER Lidocaine in the Correction of Nasolabial Folds

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

Study Overview

• Status: Completed
• Conditions: Dermatological Non-Disease
• Intervention / Treatment: Device: Princess Filler Lidocaine

Detailed Description

Clinical Investigation to assess the effectiveness of "Princess Filler Lidocaine" in reducing the severity of nasolabial folds compared to "Juvederm Ultra XC", based on the independent blinded evaluating investigator live assessment using the Nasolabial Folds Severity Rating Scale (NLF-SRS) at Week 24 after initial treatment and relative to Baseline assessments

• Study Type: Interventional
• Enrollment (Actual): 295
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Alabama
    • Birmingham, Alabama, United States, 35205
      • Gary Monheit
  • California
    • Beverly Hills, California, United States, 91436
      • John Joseph
    • San Diego, California, United States, 92121
      • Sabrina Fabi
    • Santa Monica, California, United States, 90404
      • Ava Shamban
  • Colorado
    • Greenwood Village, Colorado, United States, 80111
      • Joel Cohen
  • Florida
    • Coral Gables, Florida, United States, 33146
      • Jeremy Green
  • Maryland
    • Hunt Valley, Maryland, United States, 21030
      • Robert Weiss
  • New Jersey
    • Montclair, New Jersey, United States, 07042
      • Jeanine Downie
  • New York
    • New York, New York, United States, 10549
      • The Center for Dermatology Cosmetic and Laser Surgery
  • Pennsylvania
    • Philadelphia, Pennsylvania, United States, 19104
      • Susan Taylor
  • Tennessee
    • Nashville, Tennessee, United States, 37215
      • Michael Gold

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 22 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

1. Male or female subjects, 22 years of age or older, at the Screening visit
2. 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.
3. 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
4. Healthy skin in the nasolabial area and free of diseases that could interfere in cutaneous aging evaluation
5. 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)
6. Subjects having understood the purpose and conduct of the clinical investigation and having given written informed consent

Exclusion Criteria:

1. For females: pregnant and/or lactating or planning to become pregnant during the clinical investigation
2. History of allergies or hypersensitivity to HA preparations, lidocaine or anesthetics of any amide-based anesthetic
3. 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
4. Tendency to keloid formation, hypertrophic scars and/or pigmentation disorders
5. Known human immune deficiency virus-positive individuals
6. Presence of infectious, inflammatory or proliferative cancerous or pre-cancerous lesions in the area to be treated
7. Re-current herpes simplex in the treatment area
8. History or presence of any autoimmune or connective tissue disease, or current treatment with immunomodulating therapy
9. Uncontrolled (or instable) diabetes mellitus or systemic diseases
10. Facial plastic surgery, tissue augmentation with silicone, fat or another non-absorbable substance (permanent fillers) area of device application
11. Implantation of facial dermal fillers in the treatment area in the preceding twelve months
12. 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
13. Facial lypolysis, including submental fat treatments, within last month prior to enrollment and during the clinical investigation
14. Bariatric surgery within 12 months prior to enrollement and during the clinical investigation
15. History of bleeding disorders and/or use of anticoagulant, antiplatelet or thrombolytic medication from ten days pre- to three days post injection
16. Planned dental/oral surgery or modification (bridge-work, implants) within two weeks prior injection and to a minimum of four weeks post injection
17. Any medical condition prohibiting the inclusion in the clinical investigation according to the judgment of the treating investigator
18. Previous enrollment in this clinical investigation
19. Current participation in another clinical investigation, or treatment with any investigational drug/medical device within 30 days prior to clinical investigation enrollment
20. 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
21. 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:

1. 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)
2. 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)
3. Females of childbearing age must have a negative urine pregnancy test at the repeat-treatment visit and must agree to continue to use an adequate method of contraception for the duration of the clinical investigation
4. Healthy skin in the nasolabial area and free of diseases that could interfere in cutaneous aging evaluation and/or injection

Repeat Treatment - Exclusion Criteria:

1. Occurrence of an SAE or adverse event of special interest (AESI; i.e., changes in vision [loss of vision, blurriness, double vision, pain in or around the eye, blindness, blind spots, problems moving the eyes, change in peripheral vision], skin changing color around the eyelids or around the site of injection) during or after the initial injection and/or touch-up injection
2. Subjects who experienced visual changes or other serious medical conditions during or after the initial/touch-up injection

3. Subjects who have one of the following assessments during the visual examinations:

   • Snellen acuity test worse than 20/40 (with corrective eyewear, if applicable)
   • abnormal confrontational visual field test
   • abnormal ocular motility test
4. Subjects who became pregnant since start of the study or are planning to become pregnant during the clinical investigation
5. Known human immune deficiency virus-positive individuals
6. Presence of infectious, inflammatory or proliferative cancerous or pre-cancerous lesions in the area to be treated
7. Development of recurrent herpes simplex in the treatment area since study start
8. Development of any autoimmune or connective tissue disease since start of participation in the study, or current treatment with immunomodulating therapy
9. Development of uncontrolled (or instable) diabetes mellitus or any other systemic disease since study start
10. Development of a bleeding disorder since study start or use of anticoagulant, antiplatelet or thrombolytic medication from ten days pre- to three days post injection
11. Planned dental/oral surgery or modification (bridge-work, implants) within 2 weeks prior to injection and to a minimum of four weeks post injection
12. Any medical condition prohibiting the inclusion for repeat treatment according to the judgement of the treating investigator

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: Treatment of device 1 on left side; 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; correction of nasolabial folds
Other: Treatment of device 1 on right side; 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; correction of nasolabial folds

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Responder Status Based on Independent Photographic Reviewers Assessment at Week 24 - Full Analysis Dataset	The percentage of responders based on the independent photographic reviewers assessment at Week 24 after initial treatment and compared to Juvederm® Ultra XC and based on photographs. 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 third outcome measure to be analyzed in the hierarchical testing sequence. Statistical significance for this measure will only be assessed if the first and second outcome measures achieve statistical significance at the predefined alpha level (0.025).	Week 24
Responder Status Based on Independent Photographic Reviewers Assessment at Week 24 - Per Protocol Dataset	The percentage of responders based on the independent photographic reviewers assessment at Week 24 after initial treatment and compared to Juvederm® Ultra XC and based on photographs. 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 fourth outcome measure in the hierarchical testing sequence. Testing for this measure is contingent upon statistical significance being demonstrated for the first three outcome measures at the predefined alpha level (0.025).	Week 24
Responder Status Based on Treating Investigator Live Assessment at Week 24 - Full Analysis Set	The percentage of responders based on the treating 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 fifth outcome measure to be analyzed as part of the hierarchical testing sequence. Statistical significance will be assessed only if the first four outcome measures demonstrate statistical significance at the predefined alpha level (0.025).	Week 24
Responder Status Based on Treating Investigator Live Assessment at Week 24 - Per Protocol Set	The percentage of responders based on the treating 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 sixth outcome measure to be analyzed as part of the hierarchical testing sequence. Statistical significance will be assessed only if the first five outcome measures demonstrate statistical significance at the predefined alpha level (0.025).	Week 24
Improvement Over Baseline Based on Independent Blinded Evaluating Investigator Assessment at Week 24	The percentage of subjects with an improvement over Baseline (subjects who have been rated as "very much improved" or "much improved" or "improved"), based on the independent blinded evaluating investigator assessment at Week 24 after initial treatment and using the 5-point Global Aesthetic Improvement Scale (GAIS). GAIS grades are ranked as "very much improved", "much improved", "improved", "no change", and "worse".	Week 24
Improvement Over Baseline Based on Subject Assessment at Week 24	The percentage of subjects with an improvement over Baseline (subjects who have been rated as "very much improved" or "much improved" or "improved"), based on subject assessment at Week 24 after initial treatment and using the 5-point Global Aesthetic Improvement Scale (GAIS). GAIS grades are ranked as "very much improved", "much improved", "improved", "no change", and "worse".	Week 24

Collaborators and Investigators

• Sponsor: Croma-Pharma GmbH
• Collaborators: Syneos Health
• Investigators: Principal Investigator: Joel Cohen, MD, AboutSkin Research, LLC; Principal Investigator: David Bank, MD, Center of Dermatology, Cosmetic and Laser Surgery; 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

Study record dates

Study Major Dates

• Study Start (Actual): June 4, 2019
• Primary Completion (Actual): May 29, 2020
• Study Completion (Actual): February 15, 2022

Study Registration Dates

• First Submitted: June 17, 2019
• First Submitted That Met QC Criteria: June 17, 2019
• First Posted (Actual): June 19, 2019

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: January 14, 2025
• Last Verified: July 1, 2024

More Information

Terms related to this study

• Keywords: nasolabial folds; correction
• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Peripheral Nervous System Agents; Anesthetics, Local; Anesthetics; Central Nervous System Depressants; Sensory System Agents; Anti-Arrhythmia Agents; Voltage-Gated Sodium Channel Blockers; Sodium Channel Blockers; Membrane Transport Modulators; Lidocaine
• Other Study ID Numbers: CPH 301-201200F

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes