CompletedPhase 3

Restylane + Lidocaine and Restylane Lyft for the Treatment of Nasolabial Folds

Canada10 participantsStarted 2019-11-13

Plain-language summary

This study is designed to assess and compare the efficacy of two hyaluronic acid (HA) fillers on moderate, severe and extreme nasolabial folds (NLF).

Age range30 Years – 75 Years

SexFEMALE

See this in plain English?

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

✓. At the time of consent, women between the ages of 30 and 75 years old;
✓. Indication for treatment of bilateral NLFs and wrinkles;
✓. Willingness to comply with study requirements;
✓. Provide written consent;
✓. Accepted the obligation not to receive any other facial procedures through the follow-up;
✓. Understood and accepted the obligation and would be logistically able to appear for all scheduled follow-up visits;
✓. No previous facial fillers for a period of 12 months prior to this study;
✓. No previous facial fillers in the complete region of the NLF for 18 months prior to this study

✕. Current pregnancy or lactation \[sexually active women of childbearing age must agree to use medically acceptable methods of contraception for the duration of this study (e.g., oral contraceptives, condoms, intrauterine device, shot/injection, patch)\];
✕. Hypersensitivity to hyaluronic acid or local anesthetics;
✕. Patients meeting any official Restylane contra-indications;
✕. Patients presenting with porphyria;
✕. Inability to comply with follow-up and abstain from facial injections during the study period;
✕. Heavy smokers, classified as smoking more than 12 cigarettes per day;
✕. History of severe or multiple allergies manifested by anaphylaxis;
✕. Previous tissue revitalization therapy in the treatment area within 6 months before treatment with laser or light, mesotherapy, radiofrequency, ultrasound, cryotherapy, chemical peeling, or dermabrasion;

Skin lifting capacity of two Restylane products, as assessed by ultrasound

Timeframe: Baseline

NCT IDNCT04174131

SponsorErevna Innovations Inc.

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2019-12-12

Who can participate

Age range30 Years – 75 Years

SexFEMALE

See this in plain English?

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

✓. At the time of consent, women between the ages of 30 and 75 years old;
✓. Indication for treatment of bilateral NLFs and wrinkles;
✓. Willingness to comply with study requirements;
✓. Provide written consent;
✓. Accepted the obligation not to receive any other facial procedures through the follow-up;
✓. Understood and accepted the obligation and would be logistically able to appear for all scheduled follow-up visits;
✓. No previous facial fillers for a period of 12 months prior to this study;
✓. No previous facial fillers in the complete region of the NLF for 18 months prior to this study

✕. Current pregnancy or lactation \[sexually active women of childbearing age must agree to use medically acceptable methods of contraception for the duration of this study (e.g., oral contraceptives, condoms, intrauterine device, shot/injection, patch)\];
✕. Hypersensitivity to hyaluronic acid or local anesthetics;
✕. Patients meeting any official Restylane contra-indications;
✕. Patients presenting with porphyria;
✕. Inability to comply with follow-up and abstain from facial injections during the study period;
✕. Heavy smokers, classified as smoking more than 12 cigarettes per day;
✕. History of severe or multiple allergies manifested by anaphylaxis;
✕. Previous tissue revitalization therapy in the treatment area within 6 months before treatment with laser or light, mesotherapy, radiofrequency, ultrasound, cryotherapy, chemical peeling, or dermabrasion;