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Safety and Effectiveness of NOA HYDRATION Injectable Gel for the Improvement of Skin Quality Including Attributes Such as Skin Smoothness

RecruitingPhase 3Ages 18 Years - anyAllAbbVie
NCT07880756 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

Facial skin quality, including attributes such as skin smoothness, can be affected by intrinsic aging and environmental factors. The goal of this study is to evaluate the safety and effectiveness of NOA HYDRATION, an injectable gel designed for intradermal placement, in improving facial skin quality including attributes such as skin smoothness in Chinese adults. NOA HYDRATION is an investigational device being developed for improvement of facial skin quality including attributes such as skin smoothness. Participants are placed into one of two groups - a treatment group or a control group (no-treatment control). There is a 1 in 3 chance that participants will be assigned to the control group. Approximately 150 adult participants seeking improvement in skin quality including attributes such as skin smoothness will be enrolled at approximately 7 sites in China. Participants in the treatme

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📋 Eligibility rules (as published)
Inclusion Criteria: * Seeking improvement of skin quality including attributes such as skin smoothness * Has a symmetric ACSS score of Moderate (2) or Severe (3) on both cheeks * FACE-Q Satisfaction with Skin Questionnaire sum of raw scores \<= 39 and scores of "Very Dissatisfied" or "Somewhat Dissatisfied" on the following questions: * How hydrated your facial skin looks? * How radiant your facial skin looks? Exclusion Criteria: * History of anaphylaxis or allergy to lidocaine, HA products, or bacterial proteins * Active cutaneous inflammatory or infectious processes on the treatment area * Active autoimmune disease or uncontrolled systemic disease * Temporary soft tissue filler injections in the treatment area within 12 months * Semi-permanent fillers anywhere in the treatment area within 36 months
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What it tests

  • NOA HYDRATION
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Where

4 sites
Beijing Hospital /ID# 281119
Beijing, China
Peking Union Medical College Hospital (West) - Xidan Campus /ID# 280945
Beijing, China
Nanjing Drum Tower Hospital /ID# 281047
Nanjing, China
Zhejiang Provincial People's Hospital /ID# 281041
Hangzhou, China
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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