Comparative study on the safety and efficacy of Hyfil and Restylane for correction of nasolabial folds

Virchow Biotech Pvt Ltd0 个研究点目标入组 24 人开始时间: 待定最近更新: 2021年11月24日

试验速览

暂无简介。

•1. Subjects of both genders completed 18 years of age;
•2. Subjects with moderate to severe bilateral nasolabial folds with wrinkle severity rating scale scores of 3 or 4;
•3. Subjects willing to abstain from other cosmetic procedures (further augmentation therapy, laser or chemical skin resurfacing, botulinun toxin injections, or facelift procedures) during the study period;
•4. Subjects who are willing to sign the informed consent and will be available for all follow-up visits.
•5. Not on any painkillers/anti-inflammatory/antioxidant drugs, aspirin and other anticoagulant drugs 10 days prior to the screening;
•6.No history of keloid tendency;
•7.In case of female volunteers, negative pregnancy test during screening.

•1.Pregnant and lactating women;
•2.Subjects who had previously received facial soft tissue augmentation with hyaluronic acid or other types of fillers, or cosmetic facial surgery/implants, botulinum toxin injections, or face lift procedures within the previous 6 months from screening date.
•3.Subjects who had received laser treatment and chemical peeling in the past 3 months from screening date;
•4.Subjects with history of allergic reaction to the study product.
•5.Any medical history of systemic diseases (liver or renal functional abnormalities, uncontrolled metabolic diseases, neurological diseases) or serious medical illness;
•6.Alcohol or drug or medication abuse;
•7.Protocol non-compliant subjects;
•8.Any significant laboratory findings

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