CompletedNot Applicable

Saypha® Volume LIdocaine in Nasolabial Folds

Austria110 participantsStarted 2019-11-05

Plain-language summary

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

Who can participate

Age range18 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

✓. 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

✕. 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

What they're measuring

Responder Rate in Reduction of Nasolabial Folds

Timeframe: 24 Weeks

Trial details

NCT IDNCT04883632

SponsorCroma-Pharma GmbH

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2021-05-27

Results submitted2025-01-27

View on ClinicalTrials.gov More Moderate to Severe Nasolabial Folds trials