CompletedNot Applicable

Clinical Study to Evaluate the Correction of Wrinkles and Folds and Safety of YVOIRE Classic Versus Restylane in Nasolabial Fold Intradermal Injection

58 participantsStarted 2009-01

Plain-language summary

This study was purposed to evaluate the non-inferiority of HA IDF, a hyaluronic acid product, in terms of correction of wrinkles and safety in nasolabial fold intradermal injection, compared to Restylane, 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 and 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.

Exclusion criteria

✕. Those with a skin disease in the face (skin infection, eczema, psoriasis, rosacea, herpes etc.) or those with a history of severe allergy.
✕. Patients with a disorder in autoimmune system
✕. 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 material within 3 months prior to the study (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
✕. Women in pregnancy or lactation
✕. Hepatitis carriers or VDRL/HIV positive patients

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 IDNCT03738020

SponsorLG Life Sciences

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2009-10

Results submitted2018-11-27

View on ClinicalTrials.gov More Temporary Correction of Wrinkles trials