Saypha® Volume LIdocaine in Nasolabial Folds

Not Applicable

Completed

Conditions: Moderate to Severe Nasolabial Folds

Interventions: Combination Product: Saypha Volume Lidocaine

Registration Number: NCT04883632

Lead Sponsor: Croma-Pharma GmbH

Brief Summary: Comparison of saypha Volume Lidocaine from 2 different manufacturing locations in correcting moderate to sever nasolabial folds

Detailed Description: Following informed consent and screening, eligible subjects with moderate to severe nasolabial folds will be randomized to receive saypha® VOLUME Lidocaine from 1 of 2 manufacturing sites. The device will be injected into the deep dermis or supraperiostal, and subjects will return for follow-up assessments at Week 2, 4, 24, 36, 52 and optional at Week 65, 78 and 104 after the treatment. A Touch-up treatment may be done at Week 2, if deemed appropriate by the investigator. The performance of the investigational device will be evaluated by the investigator by assessing severity of nasolabial folds using the Nasolabial Folds Severity Rating Scale (NLF-SRS) at Week 4, 24, 36, 52 after the treatment and optional at Week 65, 78 and 104 and in comparison to Day 0. Telephone visits will be performed approximately 24 hours post-administration to monitor possible adverse events. In case any adverse events are reported during the telephone visits an unscheduled visit should be performed.

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 110

Inclusion Criteria

A subject must meet ALL of the following criteria to be eligible for the study:

Male or female 18 years of age or older
Presence of two fully visible, approximately symmetrical nasolabial folds, with each of the folds scored with 2 or 3 according to the 5-grade Nasolabial Folds Severity Rating Scale (NLF-SRS) as assessed by the investigator
Healthy skin in the facial 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
Written signed and dated informed consent

Exclusion Criteria

subject who meets ANY of the following criteria is NOT eligible for the study:

Pregnancy, lactation, planned pregnancy or unwillingness to use contraception at any time during the study (for women of child-bearing potential only)
History of mental disorders or emotional instability
History of allergic reaction or hypersensitivity to hyaluronic acid, lidocaine, or any amide-based anaesthetic
Presence of silicone implant or another non-absorbable substance (permanent fillers) in the nasolabial region
Any superficial or deep facial surgery or injection or implantation of any dermal fillers (including but not limited to hyaluronic acid, collagen, calcium hydroxylapatite, poly-l-lactic acid, polymethylmethacrylate, autologous fat injections), application of any absorbable and non-absorbable sutures (thread) for any purpose including wound care and facial lifting, any laser therapy (including but not limited to Neodym-YAG, KTP, IPL, Diode lasers as well as Erbium-YAG, CO2 or other ablative lasers), dermoabrasion, or botulinum toxin application in the nasolabial region within previous 12 months prior to enrolment, or any chemical peeling procedures (including but not limited to glycolic acid, trichloroacetic acid or phenolic peels) within previous 3 months prior to enrolment, or planning to undergo such procedures in the treatment area during the study
Presence of infectious, inflammatory, or proliferative lesions in the nasolabial region
Cutaneous lesions in the treatment area
Known human immune deficiency virus-positive individuals
History of allergies against aesthetic filling products and recurrent (3 times a year) herpes simplex in the treated area
Tendency to hypertrophic scars and/or keloid formation
History or presence of any autoimmune or connective tissue disease, or current treatment with immune therapy
Uncontrolled systemic diseases (such as diabetes mellitus)
Bariatric surgery within 12 months prior to enrollment or planned during the clinical investigation
Use of anticoagulant or thrombolytic medication from 10 days pre- to 3 days post injection
Any medical condition which, in the investigator's opinion, prohibits the inclusion in the study
Current or previous (within 30 days of enrolment) treatment with another investigational drug and/or medical device or participation in another clinical study
Previous enrolment in this clinical investigation
Subjects whose participation in clinical trials is prohibited by the Austrian Medical Devices Act (e.g., persons with a legal custodian appointed due to mental disability, prisoners, soldiers and other members of the armed forces, civil servants)
Any dental procedures one month before until one month after treatment with the investigational device

Study & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Volume Lidocaine C1	Saypha Volume Lidocaine	Subjects randomized to be treated with Saypha Volume Lidocaine manufactured in the Croma Pharma C1 Facility
Volume Lidocaine HQ	Saypha Volume Lidocaine	Subjects randomized to be treated with Saypha Volume Lidocaine manufactured in the Croma Pharma HQ Facility

Primary Outcome Measures

Name	Time	Method
Responder Rate in Reduction of Nasolabial Folds	24 Weeks	The proportion of subjects with the NLF-SRS grade reduced by ≥1 point versus baseline at Week 24. This anaylsis is done per manufacturing site: C1 and HQ separately and for the overall population. A 'responder' is defined having at least ≥ 1 grade improvement as evaluated with the 5 point-validated NLF-SRS score on both sides of the face. Nasolabial Folds Severity Rating Scale (NLF-SRS) is a validated 5 grade scale where the lower number corresponds to: 0 = None/minimal: No visible/minimal nasolabial folds; 1. = Mild: Shallow but visible nasolabial fold with a slight indentation; 2. = Moderate: Moderately deep nasolabial fold; 3. = Severe: Very deep nasolabial fold with prominent facial feature; 4. = Extreme: Extremely deep and long nasolabial fold with skin redundancy Therefore, the lower the number, the better.

Secondary Outcome Measures

Name	Time	Method
Proportion of Responders at Other Time Points	Week 4, week 36, week 52, week 65, week 78, week 104	The proportion of subjects with the NLF-SRS grade reduced by ≥1 point versus baseline at Week 4, Week 36, Week 52 and optional at Week 65, Week 78 and Week 104. A reduction in the score of the Nasolabial Folds Severity Rating Scale is considered an improvement as this reflects a decrease of the folds severity which is rated from 0 (none/minimal) to 4 (extreme). Individual NLF-SRS grades per visit calculated as the mean of grades assigned to the left and the right NLF, respectively On the Nasolabial Fold-Severity Rating Scale (NLF-SRS) higher scores indicate a greater severity of the folds: 0 = None/minimal: No visible/minimal nasolabial folds, 1 = Mild: Shallow but visible nasolabial fold with a slight indentation, 2 = Moderate: Moderately deep nasolabial fold, 3 = Severe: Very deep nasolabial fold with prominent facial feature, 4 = Extreme: Extremely deep and long nasolabial fold with skin redundancy
Change Versus Baseline in Nasolabial Fold Severitry	Week 4, Week 24, Week 36, Week 52 and, optional at Week 65, Week 78 and Week 104	The average change versus baseline in the NLF-SRS (Nasolabial Folds Severity Rating Scale) grade at Week 4, Week 24, Week 36, Week 52 and, optional at Week 65, Week 78 and Week 104 as evaluated by the investigator. A reduction in the score of the Nasolabial Folds Severity Rating Scale is considered an improvement as this reflects a decrease of the folds severity which is rated from 0 (none/minimal) to 4 (extreme). Nasolabial Folds Severity Rating Scale (NLF-SRS) is a validated 5 grade scale where the lower number corresponds to: 0 = None/minimal: No visible/minimal nasolabial folds; 1. = Mild: Shallow but visible nasolabial fold with a slight indentation; 2. = Moderate: Moderately deep nasolabial fold; 3. = Severe: Very deep nasolabial fold with prominent facial feature; 4. = Extreme: Extremely deep and long nasolabial fold with skin redundancy Therefore, the lower the number, the better.