Comparative study on the safety and efficacy of Hyfil and Restylane for correction of nasolabial folds
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 24
- 试验地点
- 1
- 主要终点
- Changes in wrinkle severity rating scale (WSRS) from baseline to 2, 8, 16, 24 weeks during post therapy ? assessment by investigator.
研究概览
简要总结
It is a Phase IV, double blind, randomized, prospective, split-face, comparative clinical study to compare the safety and efficacy of Hyfil Regular and Restylane in reducing nasolabial folds. Both male and female healthy volunteers, who completed 18 years of age and fulfill the inclusion and exclusion criteria, are taken into the study. Initial Wrinkle Severity Rating Scale (WSRS) is done separately each nasolabial folds to include only the subjects with moderate to severe folds. Laboratory investigations ? 6 ml of blood is drawn for laboratory investigations, that is, haematology (CBP, platelet count, and haemoglobin), biochemistry (alanine aminotransferase, aspartate aminotransferase and alkaline phosphatase; serum creatinine, blood urea nitrogen and random blood sugar). Urine pregnancy test is done for women of reproductive age group on baseline visit. All the laboratory reports are received & documented in order to satisfy IC/EC criteria. Those subjects with clinically insignificant laboratory findings and negative urine pregnancy test (in case of females in reproductive age group) and who are eligible will be enrolled on intervention day (Visit 2). All the subjects were followed up on week 2, 8, 16 and 24. All the investigations carried out at baseline and at the end of study period of 6 months. All the laboratory reports are documented.
研究设计
- 研究类型
- Observational
入排标准
- 年龄范围
- 18.00 Day(s) 至 70.00 Day(s)（—）
- 性别
- All
入选标准
- •Subjects of both genders completed 18 years of age;
- •Subjects with moderate to severe bilateral nasolabial folds with wrinkle severity rating scale scores of 3 or 4;
- •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;
- •Subjects who are willing to sign the informed consent and will be available for all follow-up visits.
- •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.
排除标准
- •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.
结局指标
主要结局
Changes in wrinkle severity rating scale (WSRS) from baseline to 2, 8, 16, 24 weeks during post therapy ? assessment by investigator.
时间窗: weeks 2, 8, 16 and 24
次要结局
- Changes in global aesthetic improvement scale (GAIS) from baseline to 2, 8, 16, 24 weeks during post therapy - assessment by both investigator and patient;(weeks 2, 8, 16 and 24)
- Incidence of adverse events and local injection site reactions(Week 2, 8, 16 and 24)