ISRCTN11835676已完成Unknown
A 52-week follow-up, multi-center, randomized, double-blinded comparison of efficacy and safety of two hyaluronic acid fillers for the treatment of moderate-to-severe nasolabial folds in a Chinese population
适应症
试验速览
- 阶段
- Unknown
- 状态
- 已完成
- 入组人数
- 339
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 性别
- All
入选标准
- •1. Male and female subjects aged 18-65 years
- •2. Nasolabial crease WSRS grade 3-4 and wish to correct the subject
- •3. Subjects with nasolabial crease of the same WSRS grade on both sides
- •4. Participants who agreed not to use other cosmetic treatments related to the study
- •5. Understand and comply with the requirements of the trial, can complete the whole follow-up process of the subjects
- •6. Volunteer to participate in the study and sign the informed consent form
排除标准
- •1. Pregnant or lactating women
- •2. Women of childbearing age who did not agree to use medically approved contraceptive methods (e.g. oral contraceptives, condom, intrauterine device) during the trial
- •3. The abnormal laboratory results were judged by the researcher as having clinical significance
- •4. Subjects with scarring or skin diseases in the trial treatment area that may affect the judgment of treatment efficacy, or with active inflammation and/or unhealed wounds
- •5. Subjects with active inflammation and skin infection in the experimental treatment area
- •6. Subjects who had received silicone or other permanent dermal fillers in the treatment area
- •7. Subjects who had undergone facial lifting surgery or catgut-embedding surgery within 1 year of the screening period
- •8. The subjects were treated with sodium hyaluronate or other semi-permanent dermal fillers within 1 year before the screening period
- •9. Within 6 months before the screening period, the subjects underwent other treatments such as botulinum toxin injection, radiofrequency ablation, focused ultrasound, laser peels, grinding, chemical peeling, etc
- •10. Participants who had used anticoagulant, antiplatelet, or thrombolytic therapy (e.g. , Warfarin, aspirin) within 14 days before study treatment or planned to use it within 3 days after study treatment
- •11. Had a history of multiple severe allergies, a history of inherited allergies, a history of allergy to hyaluronic acid products or streptococcal protein, and planned desensitization treatment during the study period
- •12. The subjects had a history of serious diseases of their vital organs or autoimmune diseases
- •13. The subjects had a history of hypertrophic scar or scar formation
- •14. Subjects who had participated in other clinical trials within 30 days before the screening period
- •15. The study participants were considered unsuitable for the study
研究者
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