CTRI/2023/03/050208已完成4 期
A prospective, single arm, investigator initiated clinical study to assess the safety and performance of Cross-linked Hyaluronic Acid- Dermal filler(JEUNESSO 20L) in people with all skin types, who need Lip Enhancement, Cheek bone Augmentation and Nasolabial fold improvement.
Dr. Hemant Talanikar0 个研究点目标入组 122 人开始时间: 待定最近更新:
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 122
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
入选标准
- •1.The patient must be = 18 and = 75 years of age.
- •2. The patient is willing and able to comply with the study
- •3. The patient is seeking soft tissue augmentation treatment
- •on the face.
- •4. The patient agrees to follow-up examinations out to 12
- •months post final treatment.
- •5. The patient has a pre-treatment Wrinkle Severity Rating
- •Scale (WSRS) = 2 for bilateral Nasolabial Fold (NLF) to
排除标准
- •1. At risk in term of precautions, warnings and contra indication referred in the package insert of the study
- •dermal filler
- •2. Who underwent previous injection of permanent filler in
- •the injected area
- •3. Pregnant/lactating women
- •4. Participation in any other Clinical trial.
- •5. Subjects who have an allergy to lidocaine, prilocaine or
- •other amide-type anesthetic
- •6. Had a chemical peel at the Nasolabial Fold (NLF) area
- •within 4 weeks prior to study entry. In addition, subjects
- •were restricted from undergoing chemical peels at the
- •Nasolabial Fold (NLF) area for the duration of the study
- •8. Had a history of hypo- or hyperpigmentation of the skin.
- •9. Inolerance to antibiotics or corticosteroids.
- •10. Had any infection, unhealed wound, or active
- •inflammatory process (e.g., skin eruptions such as cysts,
- •pimples, rashes, or hives) at the injection site(s).
- •11. A known history of keloids or bleeding disorders.
- •12. Leukoderma (Vitiligo) or a family history of leukoderma
- •or other pigmentary disorders.
- •13. Patient on Medication with blood thinners.
- •14. Severe physical, neurological or mental disease.
- •15. Excessive facial hair that might interfere with the study
- •of the wrinkle assessments
研究者
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