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

Not Applicable

Completed

Conditions: Dermatological Non-Disease

Interventions: Device: Princess Filler Lidocaine

Registration Number: NCT03990883

Lead Sponsor: Croma-Pharma GmbH

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

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

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 295

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
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)
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
Healthy skin in the nasolabial area and free of diseases that could interfere in cutaneous aging evaluation and/or injection

Repeat Treatment - Exclusion Criteria:

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
Subjects who experienced visual changes or other serious medical conditions during or after the initial/touch-up injection
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
Subjects who became pregnant since start of the study or are planning to become pregnant during the clinical investigation
Known human immune deficiency virus-positive individuals
Presence of infectious, inflammatory or proliferative cancerous or pre-cancerous lesions in the area to be treated
Development of recurrent herpes simplex in the treatment area since study start
Development of any autoimmune or connective tissue disease since start of participation in the study, or current treatment with immunomodulating therapy
Development of uncontrolled (or instable) diabetes mellitus or any other systemic disease since study start
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
Planned dental/oral surgery or modification (bridge-work, implants) within 2 weeks prior to injection and to a minimum of four weeks post injection
Any medical condition prohibiting the inclusion for repeat treatment according to the judgement of the treating investigator

Study & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Treatment of device 1 on right side	Princess Filler Lidocaine	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
Treatment of device 1 on left side	Princess Filler Lidocaine	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

Primary Outcome Measures

Name	Time	Method
Responder Status Based on Independent Evaluating Investigator Live Assessment at Week 24 - Full Analysis Dataset	Week 24	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.
Responder Status Based on Independent Evaluating Investigator Live Assessment at Week 24 - Per Protocol Dataset	Week 24	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).

Secondary Outcome Measures

Name	Time	Method
Responder Status Based on Independent Photographic Reviewers Assessment at Week 24 - Full Analysis Dataset	Week 24	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).
Responder Status Based on Independent Photographic Reviewers Assessment at Week 24 - Per Protocol Dataset	Week 24	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).
Responder Status Based on Treating Investigator Live Assessment at Week 24 - Full Analysis Set	Week 24	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).
Responder Status Based on Treating Investigator Live Assessment at Week 24 - Per Protocol Set	Week 24	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).
Improvement Over Baseline Based on Independent Blinded Evaluating Investigator Assessment at Week 24	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".
Improvement Over Baseline Based on Subject Assessment at Week 24	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".

Trial Locations

Locations (11): Sabrina Fabi
🇺🇸
San Diego, California, United States
Gary Monheit
🇺🇸
Birmingham, Alabama, United States
John Joseph
🇺🇸
Beverly Hills, California, United States
Ava Shamban
🇺🇸
Santa Monica, California, United States
Joel Cohen
🇺🇸
Greenwood Village, Colorado, United States
Robert Weiss
🇺🇸
Hunt Valley, Maryland, 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
Jeremy Green
🇺🇸
Coral Gables, Florida, United States
Jeanine Downie
🇺🇸
Montclair, New Jersey, United States