CompletedPhase 3

Efficacy and Safety Evaluation Study of Neuramis® Deep Lidocaine in Correction of Nasolabial Fold

South Korea60 participantsStarted 2013-06

Plain-language summary

The purpose of this study is to compare the efficacy and safety of the study medical device, Neuramis® Deep Lidocaine and the control medical device, Restylane® PERLANE-L in correction of nasolabial folds

Who can participate

Age range30 Years – 70 Years

SexALL

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Inclusion criteria

✓. Male and female aged between 30 and 70 years, inclusive
✓. Subjects who want improvement of bilateral nasolabial folds that are rated as 3 or 4 points on Wrinkle Severity Rating Scale
✓. Subjects with visually symmetrical bilateral nasolabial folds
✓. Subjects who consent to abstain from wrinkle improvement treatment in the lower face (below the lower orbital rim) during this trial
✓. Subjects who are capable of understanding and following instructions, and participating in the entire course of the trial
✓. Subjects who voluntarily decide to participate in this trial and provide written consent in the Informed Consent Form

Exclusion criteria

✕. Subjects who administered an anticoagulant (except for low-dose aspirin (100mg, up to 300mg/day) or equivalent) within 2 weeks prior to screening
✕. Subjects who had face-lift, soft tissue augmentation, medium or deeper peeling, or dermal photo-rejuvenation on the lower face (lower orbital rim) for wrinkle improvement within 6 months prior to screening
✕. Subjects who received treatment with calcium hydroxyapatite(CaHA) at the investigational medical device injection site within 1 year from screening
✕. Subjects who have implanted a permanent expander prosthesis at the investigational medical device injection site, such as soft-form or silicon
✕. Subjects with a scar or skin lesion at the investigational medical device injection site that may interfere with judgment of the treatment effect
✕. Subjects with a history of anaphylaxis or severe complicated allergy or allergy to lidocaine or hyaluronic acid products
✕. Subjects with a history of a hypertrophic scar or keloid
✕. Subjects with a skin disease or wound infection at the investigational medical device injection site

What they're measuring

Change on the Wrinkle Severity Rating Scale as evaluated by photograph raters using photographs

Timeframe: from baseline to 24 weeks

Trial details

NCT IDNCT02751034

SponsorMedy-Tox

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2013-08

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