A Phase 3 interventional study of NOA HYDRATION in Skin Quality, sponsored by AbbVie. Recruiting at 4 sites in China. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-10-19.
Sponsored by AbbVie · Phase 3, Interventional, and Treatment
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.
AbbVie is the lead sponsor of 967 studies on the registry; 132 are open to participants now.
Of its 357 completed or terminated interventional studies of FDA-regulated products, 214 (60%) have results posted.
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FACE-Q Satisfaction with Skin Questionnaire sum of raw scores \<= 39 and scores of "Very Dissatisfied" or "Somewhat Dissatisfied" on the following questions:
Exclusion Criteria:
Participants receive initial treatment with NOA HYDRATION injection at Day 1 (Baseline) and optional touch-up treatment at Day 30.
Device: NOA HYDRATION
Participants are followed for 2 months after randomization in a no-treatment control period and then either exit the study or receive optional treatment.
Device: NOA HYDRATION
Injection
Percentage of Participants With Responder Status Based on Evaluating Investigator (EI)'s Live Assessment of Allergan Cheek Smoothness Scale (ACSS)
Responder is defined as a participant with at least 1-point improvement (reduction) from Baseline on the ACSS on both cheeks. The ACSS is a validated 5-point scale developed to grade the severity of skin smoothness on the cheeks. The scale ranges from 0 (None: smooth skin) to 4 (Extreme: very rough skin with pronounced crevices). Higher scores indicate worse skin smoothness.
Time frame: Month 2
Percentage of Participants With Responder Status Based on Evaluating Investigator's Live Assessment Using the Global Aesthetic Improvement Scale (GAIS)
A responder is defined as a participant with improvement in the GAIS. The GAIS is used by the EI to assess global aesthetic improvement of the face.
Time frame: Month 2
Number of Participants With Adverse Events
An adverse event (AE) is defined as any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product which does not necessarily have a causal relationship with this treatment.
Time frame: Up to approximately 12 months
Percentage of Participants With Responder Status Based on Participant's Assessment Using the Global Aesthetic Improvement Scale (GAIS)
A responder is defined as a participant with improvement in the GAIS. The GAIS is used by the EI to assess global aesthetic improvement of the face.
Time frame: Month 2
Change From Baseline in Overall Score of FACE-Q Satisfaction With Skin
The FACE-Q Satisfaction with Skin is a validated questionnaire that assesses participant satisfaction with facial skin quality. Higher scores indicate greater satisfaction with skin.
Time frame: Baseline to Month 2
Plan to share: Yes — AbbVie is committed to responsible clinical trial data sharing. This includes access to anonymized, individual and trial-level data (analysis data sets), as well as other information.
Supporting information: Study protocol, Statistical analysis plan
Time frame: For details on when studies are available for sharing, visit https://vivli.org/ourmember/abbvie/
Access criteria: To learn more about the process, or to submit a request, visit the following link https://www.abbvieclinicaltrials.com/hcp/data-sharing/
Data sharing details ↗ · vivli.org
No publications or documents are linked to this record.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
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