Moderate to Severe Nasolabial FoldsSAVINONCT04883632
Saypha® Volume LIdocaine in Nasolabial Folds
A study testing Saypha Volume Lidocaine in people with Moderate to Severe Nasolabial Folds, run by Croma-Pharma GmbH at 3 sites in Austria.
Trial summary
Comparison of saypha Volume Lidocaine from 2 different manufacturing locations in correcting moderate to sever nasolabial folds Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Moderate to Severe Nasolabial Folds
- What is being tested?
- Saypha Volume Lidocaine
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 110 participants
- Where
- 3 sitesAustria
- Study dates
- 5 Nov 2019to 16 Feb 2022
- Phase
- Interventional
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
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- 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
Trial locations and contacts
3 sites in 1 country.
Austria3 sites
Yuvell
Vienna, 1010
Ordination Dr. Gaerner
Vienna, 1180
Privatklinik Waehring GmbH
Vienna, 1180
About this study
Official title: 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
Read the 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.
- Conditions
- Moderate to Severe Nasolabial Folds
- Being tested
- Saypha Volume Lidocaine
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Saypha Volume LidocaineCombination product
correction of Nasolabial Folds using injection of Saypha Volume Lidocaine manufactured in 2 different plants at Croma Pharma.
The amount injected depended on the size of the area to be corrected and the desired level of soft tissue augmentation. It was estimated that a maximum volume of 4 mL per treatment was needed but should not have exceeded 10 mL in total per treatment or 20 mL per year. and use in respective indications. The investigational device was administered to eligible subjects on investigation Day 0. A touchup treatment at Week 2 was optional at the investigator's discretion if full correction was
| Study group | Role | What they receive |
|---|---|---|
| Volume Lidocaine HQ | Experimental | Subjects randomized to be treated with Saypha Volume Lidocaine manufactured in the Croma Pharma HQ Facility Receives: Combination Product: Saypha Volume Lidocaine |
| Volume Lidocaine C1 | Active comparator | Subjects randomized to be treated with Saypha Volume Lidocaine manufactured in the Croma Pharma C1 Facility Receives: Combination Product: Saypha Volume Lidocaine |
What is being measured
The primary outcome is the main question the study is designed to answer.
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. 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;
- = Mild: Shallow but visible nasolabial fold with a slight indentation;
- = Moderate: Moderately deep nasolabial fold;
- = Severe: Very deep nasolabial fold with prominent facial feature;
- = Extreme: Extremely deep and long nasolabial fold with skin redundancy
Therefore, the lower the number, the better.
Measured: 24 Weeks
Secondary outcomes (2)
Proportion of Responders 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.
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
Measured: Week 4, week 36, week 52, week 65, week 78, week 104
Change Versus Baseline in Nasolabial Fold Severitry
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;
- = Mild: Shallow but visible nasolabial fold with a slight indentation;
- = Moderate: Moderately deep nasolabial fold;
- = Severe: Very deep nasolabial fold with prominent facial feature;
- = Extreme: Extremely deep and long nasolabial fold with skin redundancy
Therefore, the lower the number, the better.
Measured: Week 4, Week 24, Week 36, Week 52 and, optional at Week 65, Week 78 and Week 104
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 May 2021
- Study start5 Nov 2019
- Primary completion27 May 2021
- Study completion16 Feb 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Moderate to Severe Nasolabial FoldsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- prospective, randomized, double-blind, parallel-group, multi-center study
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 110 participants (actual)
Sponsor and investigators
- Lead sponsor
- Croma-Pharma GmbH
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04883632
- Sponsor's protocol ID
- CPH-101-201477
- Acronym
- SAVINO
- Status last verified
- Dec 2024
- First submitted
- 11 May 2021
- Last updated
- 3 Apr 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No