Status:
COMPLETED
Saypha® Volume LIdocaine in Nasolabial Folds
Lead Sponsor:
Croma-Pharma GmbH
Conditions:
Moderate to Severe Nasolabial Folds
Eligibility:
All Genders
18+ years
Phase:
NA
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 ...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
November 5 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 16 2022
Estimated Enrollment :
110 Patients enrolled
Trial Details
Trial ID
NCT04883632
Start Date
November 5 2019
End Date
February 16 2022
Last Update
April 3 2025
Active Locations (3)
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1
Yuvell
Vienna, Austria, 1010
2
Ordination Dr. Gaerner
Vienna, Austria, 1180
3
Privatklinik Waehring GmbH
Vienna, Austria, 1180