NCT02340091已完成不适用
A Randomized, Multi Center, Double-blind, Active-controlled, Matched Pairs Design Clinical Study to Evaluate the Efficacy and Safety of HA IDF Plus Versus HA IDF in Nasolabial Fold Injection
LG Life Sciences0 个研究点目标入组 62 人开始时间: 2014年2月1日最近更新:
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 62
- 主要终点
- Proportion of the Subjects With at Least 10mm Difference in VAS Pain Scale Scores Within the Subject (VAS of the Control Medical Device - VAS of the Test Medical Device) Immediately After Treatment With the Investigational Medical Devices
研究概览
简要总结
The objective of this study was to evaluate the efficacy and safety of HA IDF plus (with lidocaine) injected in the nasolabial fold compared to HA IDF (without lidocaine).
详细描述
The objective of this study was to confirm the superiority of HA IDF II plus (with lidocaine) injected in the nasolabial fold compared to HA IDF II (without lidocaine) in the improvement of local pain and evaluate the wrinkle-correcting effect, GAI and safety.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 30 Years 至 60 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Women aged between 30 and 60
- •Those whose wrinkles in the treatment area (nasolabial fold) correspond to Stage 3 or 4 in the 5-stage Wrinkle Severity Rating Scale (WSRS) symmetrically
- •Those who were informed on the purpose, method, and effect etc. of this study and signed the informed consent form
- •Those who fell under any of the following 3 cases:
- •Surgically sterile women
- •Women in menopause over 2 years from the last menstruation, aged at least 45
- •Among the women meeting neither of a nor b, those who agreed to use at least 2 contraception methods specified below (one of the barrier methods must be included) until 14 days after the last treatment with the investigational medical device
- •Barrier methods: Condom, diaphragm, cervical cap (pessary), spermicide
- •Hormonal methods: Pills, injection (depot), skin patch, hormonal implant (Implanon), vaginal ring
- •Intrauterine devices (IUDs): Cooper IUD (Loop), hormonal IUD (Mirena)
- •Natural methods: Basic body temperature, ovulation period, coitus interrupts, abstinent
排除标准
- •Those with a skin disease (skin infection, eczema, psoriasis, rosacea, herpes etc.) in the lower 2/3 part of the face in which the wrinkle evaluation may be affected
- •Patients who had been treated for a malignant tumor within 5 years prior to Visit 2 (randomization)*
- •Women in pregnancy or lactation
- •Those with the bilirubin level exceeding 1.5x of the upper limit of normal or the ALT/AST level exceeding 2.5x of the upper limit of normal
- •Those with the confirmed infection of syphilis or HIV
- •Those who had an anticoagulant therapy or antiplatelet therapy within 2 weeks prior to Visit 1 (screening)
- •Those who used a topical preparation (steroid, retinoid) in the facial area within 4 weeks prior to Visit 2 (randomization)
- •Those who experienced a deep chemical peeling or a laser procedure (including IPL) within 3 months prior to Visit 2 (randomization)
- •Those who experienced a non-permanent filler procedure or a cosmetic surgery in the face within 9 months prior to Visit 2 (randomization)
- •Those who had an implantation procedure with a permanent substance (silicone, PAAG, PMMA, CaHA etc.) in the treatment area (nasolabial fold )
- •Those currently with a streptococcal disease
- •Those with a history of severe allergy or hypersensitivity (anaphylaxis) judged as potentially affecting the clinical study
- •Those with a history of hypertrophic scar or keloid
- •Those with a history of bleeding disorder
- •Those with a hypersensitivity to the investigational medical device of this clinical study or lidocaine
- •Those who refused to agree not to use a local or systemic pain-relieving agent or other pain-relieving method (e.g.: ice pack) from the midnight of the treatment day with the investigational medical device through the post-measurement of the last VAS pain scale
- •Those who had participated in another clinical study within 1 month prior to Visit 1 (screening)
- •Those judged by the investigator as ineligible for this clinical study * Excluded were the patients with treated basal cell or squamous cell skin cancer or treated cervical cancer, of which the location is not the lower 2/3 part of the face.
研究组 & 干预措施
HA IDF plus
Experimental
cross-linked HA filler with lidocaine
干预措施: HA IDF plus (Device)
HA IDF
Active Comparator
cross-linked HA filler without lidocaine
干预措施: HA IDF (Device)
结局指标
主要结局
Proportion of the Subjects With at Least 10mm Difference in VAS Pain Scale Scores Within the Subject (VAS of the Control Medical Device - VAS of the Test Medical Device) Immediately After Treatment With the Investigational Medical Devices
时间窗: Visit 2 (week 0, immediately after treatment)
The degree of pain was evaluated by VAS (Visual Analog Scale), measuring the length from the left and to the mark by the subject in millimeter (mm) unit.
次要结局
未报告次要终点
研究者
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