SAVINO (Saypha® Volume LIdocaine in Nasolabial FOlds)

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

Detailed Description
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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.

Official Title
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A Prospective, Randomized, Multicenter Study Evaluating Saypha® VOLUME Lidocaine* for the Correction of Nasolabial Fold

Conditions
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Moderate to Severe Nasolabial Folds

Intervention / Treatment
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* Combination Product: Saypha Volume Lidocaine


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: prospective, randomized, double-blind, parallel-group, multi-center study
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Volume Lidocaine HQ<br>Subjects randomized to be treated with Saypha Volume Lidocaine manufactured in the Croma Pharma HQ Facility | Combination Product: Saypha Volume Lidocaine<br>* correction of Nasolabial Folds using injection of Saypha Volume Lidocaine manufactured in 2 different plants at Croma Pharma<br>|
| Active Comparator: Volume Lidocaine C1<br>Subjects randomized to be treated with Saypha Volume Lidocaine manufactured in the Croma Pharma C1 Facility | Combination Product: Saypha Volume Lidocaine<br>* correction of Nasolabial Folds using injection of Saypha Volume Lidocaine manufactured in 2 different plants at Croma Pharma<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Responder Rate in reduction of Nasolabial folds | The proportion of subjects with the NLF-SRS grade reduced by ≥1 point versus baseline at Week 24, within each manufacturing site, C1 and HQ, separately and for the whole analysis population | 24 Weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change versus Baseline in Nasolabial Fold Severitry | The average change versus baseline in the NLF-SRS 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 | 104 Weeks | 
| Responder Rates at other time points | 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 | 104 Weeks |