Clinical trial NCT03990883: Effectiveness and Safety of Princess FILLER Lidocaine in Correction of Nasolabial Folds (NLF)
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Dermatological Non-Disease
Keywords: nasolabial folds
correction
Lead sponsor: Croma-Pharma GmbH
Sponsor class: INDUSTRY
Collaborators: name: Syneos Health
First posted: 2019-06-19
Enrollment: 295
Sex: ALL
Minimum age (years): 22
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Pivotal study
Primary purpose: TREATMENT

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

Eligibility criteria: 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

Primary outcomes:
measure: Responder Status Based on Independent Evaluating Investigator Live Assessment at Week 24 - Full Analysis Dataset
timeFrame: Week 24
measure: Responder Status Based on Independent Evaluating Investigator Live Assessment at Week 24 - Per Protocol Dataset
timeFrame: Week 24
Secondary outcomes:
measure: Responder Status Based on Independent Photographic Reviewers Assessment at Week 24 - Full Analysis Dataset
timeFrame: Week 24
measure: Responder Status Based on Independent Photographic Reviewers Assessment at Week 24 - Per Protocol Dataset
timeFrame: Week 24
measure: Responder Status Based on Treating Investigator Live Assessment at Week 24 - Full Analysis Set
timeFrame: Week 24
measure: Responder Status Based on Treating Investigator Live Assessment at Week 24 - Per Protocol Set
timeFrame: Week 24
measure: Improvement Over Baseline Based on Independent Blinded Evaluating Investigator Assessment at Week 24
timeFrame: Week 24
measure: Improvement Over Baseline Based on Subject Assessment at Week 24
timeFrame: Week 24
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: Gary Monheit
state: Alabama
city: Beverly Hills
country: United States
facility: John Joseph
state: California
city: San Diego
country: United States
facility: Sabrina Fabi
state: California
city: Santa Monica
country: United States
facility: Ava Shamban
state: California
city: Greenwood Village
country: United States
facility: Joel Cohen
state: Colorado
city: Coral Gables
country: United States
facility: Jeremy Green
state: Florida
city: Hunt Valley
country: United States
facility: Robert Weiss
state: Maryland
city: Montclair
country: United States
facility: Jeanine Downie
state: New Jersey
city: New York
country: United States
facility: The Center for Dermatology Cosmetic and Laser Surgery
state: New York
city: Philadelphia
country: United States
facility: Susan Taylor
state: Pennsylvania
city: Nashville
country: United States
facility: Michael Gold
state: Tennessee
Study officials:
affiliation: Center of Dermatology, Cosmetic and Laser Surgery
name: David Bank, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: AboutSkin research, LLC
name: Joel Cohen, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Dr. John Joseph Facial Plastic and Reconstructive Surgery
name: John Joseph, MDE
role: PRINCIPAL_INVESTIGATOR
affiliation: Total Skin and Beauty Dermatology Center
name: Gary Monheit, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Ava MD
name: Ava Shamban, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Pennsylvania
name: Susan Taylor, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Maryland Laser Skin and Vein
name: Robert Weiss, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Cosmetic, Lazer, Dermatology
name: Sabrina Fabi, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Image Dermatology P.C.
name: Jeanine Downie, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Skin Research Institute
name: Jeremy Green, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Tennesse Clinical Research Institute
name: Michael Gold, MD
role: PRINCIPAL_INVESTIGATOR
References: