CompletedNot Applicable

Clinical Study to Evaluate the Correction of Facial Wrinkles and Folds and Safety of YVOIRE Volume Versus Perlane in Nasolabial Fold Injection

57 participantsStarted 2010-03

Plain-language summary

This study was purposed to evaluate the non-inferiority of YVOIRE volume, a hyaluronic acid product, in terms of correction of wrinkles and safety in nasolabial fold deep-dermal injection, compared to Perlane, the control preparation.

Who can participate

Age range30 Years – 55 Years

SexALL

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Inclusion criteria

✓. Age: Women in 30\~55 years.
✓. Those whose wrinkle scores in the treatment site (nasolabial fold) at the screening visit were Stage 3 or 4 in the 5-stage Wrinkle Severity Rating Scale (WSRS) symmetrically
✓. Those who were informed on this study in detail, understood it completely, decided to participate in the study own their own and signed on the informed consent form.

Exclusion criteria

✕. Those with a skin disease in the face (skin infection, eczema, psoriasis, rosacea, herpes etc.)
✕. Those with a history of severe allergy
✕. Those with hypertrophic scar or a history of kelloid
✕. Patients with an autoimmune disease
✕. Those with hepatic dysfunction or abnormality in coagulation, or those administering an anticoagulant (aspirin, warfarin etc.) concomitantly
✕. Those who had used a local topical preparation (steroid, retinoid) within 4 weeks prior to the study
✕. Those who had underwent a chemical peeling, laser procedure (including IPL) or insertion of other bioadaptive materials (however, those who had been treated with HA filler could participate in the study if the date of treatment was known and the investigator judged that the filler effect had disappeared).
✕. Patients with a malignant tumor

What they're measuring

Average of Wrinkle Severity Rating Scale (WSRS) score evaluated by the evaluating investigator at Week 26 (Visit 7) after the final treatment with the investigational medical device.

Timeframe: Week 26 (Visit 7)

Trial details

NCT IDNCT03738007

SponsorLG Life Sciences

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2010-12

View on ClinicalTrials.gov More Temporary Correction of Wrinkles trials