IRCT20150101020514N27招募中2 期
A single-arm, before- after clinical study to evaluate the safety and efficacy of Intella dermal filler (produced by Espad Pharmed Darou Co.) for correction of moderate to severe nasolabial folds
ESpadpharmed 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 year old men and women
- •Moderate to severe nasolabial folds based on Allergan criteria
- •The opportunity to accompany the visit programs and study process.
- •Signing the informed consent form and agree to a 6-month follow-up
排除标准
- •History of type 1 allergic reactions or anaphylaxis reaction
- •Previous hyaluronic acid-based dermal filler injected within the last 12 months prior to enrollment.
- •History of hypertrophic and keloid scars or bleeding disorders in the nasolabial region
- •Active inflammatory processes, infection, lesions (cancerous/non-cancerous) in the nasolabial region
- •History of autoimmune diseases/immune deficiency or use of immunosuppressive medicines during the 6 months before entering the study or during the study
- •Pregnancy or lactation
研究者
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