ISRCTN37981524进行中（未招募）Unknown
Safety and effectiveness clinical evaluation of injectable medical device hydragel A2 in the improvement of skin quality
ouna Aesthetics0 个研究点目标入组 49 人开始时间: 2023年10月17日最近更新:
适应症
试验速览
- 阶段
- Unknown
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 49
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
- 性别
- All
入选标准
- •Current inclusion criteria as of 12/02/2024:
- •1. Female or male
- •2. Any ethnicity
- •3. Skin phototype (according to Fitzpatrick scale) from II to V
- •4. Aged 30 to 60 years old
- •5. Seeking improvement of their skin quality
- •6. Have given consent for photographs for illustration purposes
- •7. Willing to abstain from other facial aesthetic procedures in the mid-face through the entire study duration
- •8. In good general and mental health in the opinion of the investigator
- •9. Have the ability to read and fully understand the aims of the study and its conduct and have given their free, informed and expressed written consent
- •10. Agreeing to cooperate, in full awareness of the study objectives, the necessity and the duration of the follow-up controls at the trial site to ensure perfect adherence to protocol
- •11. In the judgement of the investigator, are likely to be compliant during the study
- •12. Willing and capable of following the study rules and a fixed schedule
- •13. Willing and capable of signing an informed consent document (including the language)
- •Previous inclusion criteria:
- •1. Female or male
- •2. Any ethnicity
- •3. Skin phototype (according to Fitzpatrick scale) from II to V
- •4. Aged 18 to 45 years old
- •5. Seeking improvement of their skin quality
- •6. Have given consent for photographs for illustration purposes
- •7. Willing to abstain from other facial aesthetic procedures in the mid-face through the entire study duration
- •8. In good general and mental health in the opinion of the investigator
- •9. Have the ability to read and fully understand the aims of the study and its conduct and have given their free, informed and expressed written consent
- •10. Agreeing to cooperate, in full awareness of the study objectives, the necessity and the duration of the follow-up controls at the trial site to ensure perfect adherence to protocol
- •11. In the judgement of the investigator, are likely to be compliant during the study
- •12. Willing and capable of following the study rules and a fixed schedule
- •13. Willing and capable of signing an informed consent document (including the language)
排除标准
- •1. Any systemic disorder or skin disease that would in any way confound the interpretation of the study results
- •2. Medical/surgical/severe allergy/anaphylactic shock history that, in the opinion of the Investigator, could compromise the safety of the participant or affect the outcome of the study
- •3. Known risk of hypersensitivity to one of the components of the IP composition
- •4. Suffering from autoimmune disease
- •5. Cutaneous disorders, inflammation or infection (herpes, acne, etc.) at the treatment site or nearby
- •6. Medical history shows a sensitivity that could lead to a reaction to the treatment
- •7. Bleeding disorders or undergoing treatment with thrombolytics or anticoagulants
- •8. A tendency to form keloids, hypertrophic scars or any other healing disorders
- •9. Currently following a skin treatment
- •10. Pregnant or breastfeeding women or those considering a pregnancy during the study
- •11. Female subjects of childbearing potential with a positive urine pregnancy test (UPT) at D-3-D0
- •12. Deprived of their freedom by administrative or legal decision or who is under guardianship
- •13. Cannot be contacted by telephone in case of emergency
- •14. In an exclusion period or participating in another biomedical research study (self-reported)
- •15. Intellectual/mental inability to follow study instructions (if suspected) or incapacitation
研究者
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