Saypha® Volume LIdocaine in Nasolabial Folds

NCT ID: NCT04883632

Last Updated: 2025-04-03

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 110 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-11-05
• Study Completion Date: 2022-02-16

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.

Conditions

Moderate to Severe Nasolabial Folds

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

Volume Lidocaine HQ

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

Group Type: EXPERIMENTAL

Saypha Volume Lidocaine

Intervention Type: COMBINATION_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

Volume Lidocaine C1

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

Group Type: ACTIVE_COMPARATOR

Saypha Volume Lidocaine

Intervention Type: COMBINATION_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

Interventions

Saypha Volume Lidocaine

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

Intervention Type: COMBINATION_PRODUCT

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Croma-Pharma GmbH

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Yuvell

Vienna, , Austria

Ordination Dr. Gaerner

Vienna, , Austria

Privatklinik Waehring GmbH

Vienna, , Austria

Countries

Austria

Provided Documents

Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Other Identifiers

CPH-101-201477

Identifier Type: -

Identifier Source: org_study_id