SAVINO (Saypha® Volume LIdocaine in Nasolabial FOlds)

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

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

Study Overview

• Status: Completed
• Conditions: Moderate to Severe Nasolabial Folds
• Intervention / Treatment: Combination product: Saypha Volume Lidocaine

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.

• Study Type: Interventional
• Enrollment (Actual): 110
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Austria
  • Vienna, Austria, 1010
    • Yuvell
  • Vienna, Austria, 1180
    • Dr. Gaerner
  • Vienna, Austria, 1180
    • Dr. Worseg

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

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

1. Male or female 18 years of age or older
2. 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
3. Healthy skin in the facial area and free of diseases that could interfere in cutaneous aging evaluation
4. Willingness to abstain from any aesthetic or surgical procedures in the treatment area for the duration of the clinical investigation
5. Written signed and dated informed consent

Exclusion Criteria:

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

1. Pregnancy, lactation, planned pregnancy or unwillingness to use contraception at any time during the study (for women of child-bearing potential only)
2. History of mental disorders or emotional instability
3. History of allergic reaction or hypersensitivity to hyaluronic acid, lidocaine, or any amide-based anaesthetic
4. Presence of silicone implant or another non-absorbable substance (permanent fillers) in the nasolabial region
5. 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
6. Presence of infectious, inflammatory, or proliferative lesions in the nasolabial region
7. Cutaneous lesions in the treatment area
8. Known human immune deficiency virus-positive individuals
9. History of allergies against aesthetic filling products and recurrent (3 times a year) herpes simplex in the treated area
10. Tendency to hypertrophic scars and/or keloid formation
11. History or presence of any autoimmune or connective tissue disease, or current treatment with immune therapy
12. Uncontrolled systemic diseases (such as diabetes mellitus)
13. Bariatric surgery within 12 months prior to enrollment or planned during the clinical investigation
14. Use of anticoagulant or thrombolytic medication from 10 days pre- to 3 days post injection
15. Any medical condition which, in the investigator's opinion, prohibits the inclusion in the study
16. Current or previous (within 30 days of enrolment) treatment with another investigational drug and/or medical device or participation in another clinical study
17. Previous enrolment in this clinical investigation
18. 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)
19. Any dental procedures one month before until one month after treatment with the investigational device

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: TRIPLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Volume Lidocaine HQ; Subjects randomized to be treated with Saypha Volume Lidocaine manufactured in the Croma Pharma HQ Facility	Combination product: Saypha Volume Lidocaine; correction of Nasolabial Folds using injection of Saypha Volume Lidocaine manufactured in 2 different plants at Croma Pharma
ACTIVE_COMPARATOR: Volume Lidocaine C1; Subjects randomized to be treated with Saypha Volume Lidocaine manufactured in the Croma Pharma C1 Facility	Combination product: Saypha Volume Lidocaine; correction of Nasolabial Folds using injection of Saypha Volume Lidocaine manufactured in 2 different plants at Croma Pharma

What is the study measuring?

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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Response ≥2 Points	The proportion of subjects with the NLF-SRS grade reduced by ≥2 point versus baseline at Week 4, Week 24, Week 36 and Week 52 and optional at Week 65, Week 78 and Week 104.	104 Weeks
Aesthetic Improvement using GAIS	The proportion of subjects with aesthetic improvement at Week 4, Week 24, Week 36, Week 52 and optional at Week 65, Week 78 and Week 104, as evaluated by the subject using the Global Aesthetic Improvement Scale (GAIS)	104 Weeks
Subject Satisfaction using Face-Q questionnaire	Subjects' satisfaction with aesthetic outcome of the treatment at Week 4, Week 24, Week 36, Week 52 and optional at Week 65, Week 78 and Week 104 using the Face-Q Satisfaction with outcome Scale as evaluated by the subject	104 Weeks
Pain Assessment	The average pain intensity during and after the treatment, as evaluated by the subject using an 11-point Numeric Pain Rating Scale (NPRS) immediately after the last injection and 15 min. thereafter, respectively	Immetiately after and 15 Minutes after Injection
Responder Rate based on photographic review	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 as evaluated by the independent reviewer of photographs.	104 Weeks

Collaborators and Investigators

• Sponsor: Croma-Pharma GmbH
• Investigators: Principal Investigator: Monika Sulovsky, Dr., Yuvell - H&P Ambulatorien GmbH (Study Site)

Study record dates

Study Major Dates

• Study Start (ACTUAL): November 5, 2019
• Primary Completion (ACTUAL): May 26, 2021
• Study Completion (ACTUAL): July 15, 2022

Study Registration Dates

• First Submitted: May 11, 2021
• First Submitted That Met QC Criteria: May 11, 2021
• First Posted (ACTUAL): May 12, 2021

Study Record Updates

• Last Update Posted (ACTUAL): July 20, 2022
• Last Update Submitted That Met QC Criteria: July 19, 2022
• Last Verified: July 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Anti-Arrhythmia Agents; Central Nervous System Depressants; Peripheral Nervous System Agents; Sensory System Agents; Anesthetics; Membrane Transport Modulators; Anesthetics, Local; Voltage-Gated Sodium Channel Blockers; Sodium Channel Blockers; Lidocaine
• Other Study ID Numbers: CPH-101-201477

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: No