IRCT20150101020514N11招募中2 期
Safety and effectiveness assessment of Lunafill Ultra intradermal injectable gel containing hyaluronic acid ( 24mg/ml) and lidocaine 0.3% for correcting nasolabial folds. Phase II, before after clinical study
Zist orchid pharmed Company0 个研究点目标入组 30 人开始时间: 待定最近更新:
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 发起方
- 入组人数
- 30
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
- 年龄范围
- 18 years 至 65 years（—）
- 性别
- All
入选标准
- •18 -65 years old men and women
- •Moderate to severe nasolabial folds
- •Signing the infirmed consent form
排除标准
- •Previous hyaluronic acid (HA)-based dermal filler treatment(s) injected within the last 12 months prior to enrollment
- •Cosmetic facial procedures (chemical peel, laser, radio frequency, dermabrasion, ablative or non-ablative procedures), Botox) in the lower 2/3 of the face, within 3 month prior to study entry
- •Planning to undergo any of these procedures at any time during the study
- •Allergy or sensitivity to lidocaine, hyaluronic acid products
- •Active inflammation, infection, cancerous or pre-cancerous lesion or unhealed wound in the NLF region
- •Current treatment with anti-coagulation therapy or use of non-steroidal anti-inflammatory drugs or other substances known to increase coagulation time within 10 days of undergoing study injections
- •People prone to hypertrophic scar formation
- •History of ant auto immune or immune deficiency diseases or using any immune suppressive drug
- •Pregnancy and breast feeding
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