Skin QualityPhase 3NCT07880756
Safety and Effectiveness of NOA HYDRATION Injectable Gel for the Improvement of Skin Quality Including Attributes Such as Skin Smoothness
A Phase 3 study testing NOA HYDRATION in people with Skin Quality, run by AbbVie at 4 sites in China.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Skin Quality
- What is being tested?
- NOA HYDRATION
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 150 participants
- Where
- 4 sitesChina
- Study dates
- 16 Sep 2026to Feb 2028
- Phase
- Phase 3
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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?
Who cannot join
- 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
Trial locations and contacts
4 sites in 1 country. Contact the study team or a site near you to ask about taking part.
China4 sites, 4 recruiting
- Recruiting
Beijing Hospital /ID# 281119
Beijing, Beijing Municipality, 100005
- Recruiting
Peking Union Medical College Hospital (West) - Xidan Campus /ID# 280945
Beijing, Beijing Municipality, 100032
- Recruiting
Zhejiang Provincial People's Hospital /ID# 281041
Hangzhou, Zhejiang, 310014
- Recruiting
Nanjing Drum Tower Hospital /ID# 281047
Nanjing, Jiangsu, 210008
About this study
Official title: A Prospective, Multicenter, Evaluator-Blinded, Randomized, No-treatment-controlled Study to Evaluate the Safety and Effectiveness of NOA HYDRATION in the Improvement of Skin Quality Including Attributes Such as Skin Smoothness
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.
Read more
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.
- Conditions
- Skin Quality
- Being tested
- NOA HYDRATION
- Keywords
- Skin Quality, NOA HYDRATION, Aging
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NOA HYDRATIONDevice
Injection
| Study group | Role | What they receive |
|---|---|---|
| Treatment Group | Experimental | Participants receive initial treatment with NOA HYDRATION injection at Day 1 (Baseline) and optional touch-up treatment at Day 30. Receives: Device: NOA HYDRATION |
| Control Group | Other | Participants are followed for 2 months after randomization in a no-treatment control period and then either exit the study or receive optional treatment. Receives: Device: NOA HYDRATION |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: Up to approximately 12 months
Secondary outcomes (2)
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.
Measured: 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.
Measured: Baseline to Month 2
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Oct 2026
- Study start16 Sep 2026
- Primary completionFeb 2028 (estimated)
- Study completionFeb 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Skin QualityStudies of the same condition, open and under way.
- More trials run by AbbVieThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- AbbVie
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- ABBVIE INC., Study director, AbbVie
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07880756
- Sponsor's protocol ID
- M23-065
- Status last verified
- Oct 2026
- First submitted
- 12 Oct 2026
- Last updated
- 19 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- 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.
Study at a glance
From the registry record, last updated by the sponsor on 19 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Multicenter, Evaluator-Blinded, Randomized, No-treatment-controlled Study to Evaluate the Safety and Effectiveness of NOA HYDRATION in the Improvement of Skin Quality Including Attributes Such as Skin Smoothness
- ClinicalTrials.gov ID
- NCT07880756
- Acronym / sponsor ID
- M23-065
- Conditions
- Skin Quality
- Keywords
- Skin Quality, NOA HYDRATION, Aging
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- AbbVieIndustry (pharma, biotech, devices)
- Study start
- 16 Sep 2026 (actual)
- Primary completion
- Feb 2028 (estimated)
- Study completion
- Feb 2028 (estimated)
- First posted
- 19 Oct 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Treatment Group | Experimental | Device: NOA HYDRATIONParticipants receive initial treatment with NOA HYDRATION injection at Day 1 (Baseline) and optional touch-up treatment at Day 30. |
| Control Group | Other | Device: NOA HYDRATIONParticipants are followed for 2 months after randomization in a no-treatment control period and then either exit the study or receive optional treatment. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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:
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| NOA HYDRATIONInjection | Device | Control Group, Treatment Group |
Primary outcome
Percentage of Participants With Responder Status Based on Evaluating Investigator (EI)'s Live Assessment of Allergan Cheek Smoothness Scale (ACSS)
Time frame: Month 2
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.
Percentage of Participants With Responder Status Based on Evaluating Investigator's Live Assessment Using the Global Aesthetic Improvement Scale (GAIS)
Time frame: Month 2
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.
Number of Participants With Adverse Events
Time frame: Up to approximately 12 months
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.
2 secondary outcomes
Percentage of Participants With Responder Status Based on Participant's Assessment Using the Global Aesthetic Improvement Scale (GAIS)
Time frame: Month 2
Change From Baseline in Overall Score of FACE-Q Satisfaction With Skin
Time frame: Baseline to Month 2
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Oct 2026.
- Individual participant dataSharing planned: 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
ABBVIE INC. study director
AbbVie
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing NOA HYDRATION in people with Skin Quality, run by AbbVie at 4 sites in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 19 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact ABBVIE CALL CENTER (844-663-3742, abbvieclinicaltrials@abbvie.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of Participants With Responder Status Based on Evaluating Investigator (EI)'s Live Assessment of Allergan Cheek Smoothness Scale (ACSS) (time frame: Month 2). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Oct 2026.