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RECRUITING Phase 3 ClinicalTrials.gov

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

Sponsor: AbbVie • ClinicalTrials.gov ID: NCT07880756

Registry updated: 2026-10-19
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Description

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 treatment group will receive intradermal injections of NOA HYDRATION to the facial area (excluding forehead, nose, lips, and periocular areas) on Day 1. An optional touch-up treatment may be given at Day 31. The treatment group will be followed for 12 months after the last treatment. Participants in the control group will receive no treatment for 2 months, then may receive optional treatment and will be followed for 9 months after treatment. There may be higher treatment burden for participants in this trial compared to their standard of care due to study procedures. Participants will attend regular visits during the study at a clinic. The effects of the treatment will be checked by medical assessments, questionnaires, photography, and checking for side effects.

Interventions

  • NOA HYDRATION (Device)
    Injection

Eligibility criteria

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

Conditions

Skin Quality

Locations

  • Beijing Hospital /ID# 281119 — Beijing, Beijing Municipality, China
  • Peking Union Medical College Hospital (West) - Xidan Campus /ID# 280945 — Beijing, Beijing Municipality, China
  • Nanjing Drum Tower Hospital /ID# 281047 — Nanjing, Jiangsu, China
  • Zhejiang Provincial People's Hospital /ID# 281041 — Hangzhou, Zhejiang, China
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Official Source

Data sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

View Official Record