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临床试验/CTRI/2023/03/050208
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

发起方
Dr. Hemant Talanikar

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