Dry Skin in the ElderlyNCT07133971
A Clinical Observational Study Evaluating the Efficacy of Cerave Neuroceramide Intensive Repair Body Lotion .
An observational study of Dry Skin in the Elderly, run by ChinaNorm.
Trial summary
This study is a single-center observational clinical study aimed at evaluating the impact of Cerave Neuroceramide Moisturizing Repair Body Lotion on the quality of life, improvement in skin condition, and satisfaction with the product experience among individuals with moderate to severe dry skin associated with aging. Read more about this study
- Who is it for?
- Ages 55 years and older
- Conditions the study is for
- Dry Skin in the Elderly
- What is being tested?
- skin care product（Cerave Neuroceramide Moisturizing Repair Body Lotion）
- How many people
- 210 participants
- Where
- No sites listed yet
- Study dates
- 22 Aug 2025to Jan 2026
- Phase
- Observational
- 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 55 years and older
- All sexes
- Adult, Older adult
Study population: Male or female study participants aged 55 years or older with moderate to severe skin dryness.
Who may be able to join
- Individuals with moderate to severe skin dryness as assessed by a clinician (ODS score of 2 or 3)
- Individuals with moderate to severe self-reported skin itching as assessed by a clinician (NRS ≥ 1)
- Individuals aged 55 years and older
- Open to patients with one or more of the following conditions:
- History of atopic dermatitis;
- Currently using a stable medication regimen prescribed and monitored by a physician (ongoing use), where the medication has side effects causing skin dryness (e.g., statins, calcium channel blockers, diuretics, antiplatelet agents, ACE inhibitors, beta-blockers, adrenergic receptor agonists, immunosuppressants, etc.);
- Patients with systemic diseases associated with dryness (diagnosed and managed by a physician), such as diabetes, hyperthyroidism, hypothyroidism, or hemodialysis.
- Voluntarily participate in the trial, understand and agree to sign the informed consent form, and agree to follow the study protocol throughout the study period, including using the study-provided products, not using other similar products, completing a diary, and attending regular follow-up visits as required by the trial.
Who cannot join
- Individuals with a history of allergy, allergic reaction, or hypersensitivity to any component of the study product (Cerave Neuroceramide Moisturizing Repair Body Lotion);
- Individuals with a history of allergic contact dermatitis secondary to the use of moisturizing products;
- Individuals with any clinical manifestations or other conditions at the treatment site that the physician deems may affect the evaluation or results of the study product;
- Individuals who are unable or unwilling to attend all study visits and adhere to the treatment regimen;
- Individuals who have participated in any other drug clinical studies within the past 3 months prior to the start of the trial.
About this study
Official title: A Clinical Observational Study Evaluating the Efficacy of Cerave Neuroceramide Intensive Repair Body Lotion in Improving Dry Skin in the Elderly
This study is a single-center observational clinical study aimed at evaluating the impact of Cerave Neuroceramide Moisturizing Repair Body Lotion on the quality of life, improvement in skin condition, and satisfaction with the product experience among individuals with moderate to severe dry skin associated with aging. The study plans to recruit approximately 210 male or female participants aged 55 years or older with moderate to severe skin dryness in the affected areas (accounting for a dropout rate and protocol violation rate of no more than 5%), and will screen participants based on inclusion and exclusion criteria to ensure that at least 200 participants complete the study. Participants entering this study will be categorized based on ODS and NRS scores into: moderate or severe skin dryness (moderate-grade 2, severe-grade 3), with the sample size ratio between moderate and severe groups maintained at 1:1. This study will last for 4 weeks and include 2 visits. Visits will be conducted at baseline (T0) and week 4 (T4w). The window period for the week 4 (T4w) visit is ±2 days. This study does not involve randomization. All study participants will use Cerave Neuroceramide Moisturizing Repair Body Lotion on areas of skin dryness.
- Conditions
- Dry Skin in the Elderly
- Being tested
- skin care product（Cerave Neuroceramide Moisturizing Repair Body Lotion）
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
skin care product（Cerave Neuroceramide Moisturizing Repair Body Lotion）Other
All study participants will use Cerave Neuroceramide Moisturizing Body Lotion during the trial period, applying it every night to dry skin areas. If topical medications are used, they should be applied first to dry skin areas, followed by the product.
| Study group | Role | What they receive |
|---|---|---|
| Patients with moderate to severe skin dryness | Based on ODS and NRS scores, patients with moderate to severe skin dryness (moderate-grade 2, severe-grade 3) were assessed. Receives: Other: skin care product（Cerave Neuroceramide Moisturizing Repair Body Lotion） |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in ODS grading before and after using the trial product
The Overall Dry Skin Score (ODS) is used to comprehensively assess the severity of objective findings of skin dryness. The following are the skin manifestations and scores for ODS grading:
A score of 0 indicates no dryness symptoms, smooth skin, no scaling, no roughness, no erythema, and no fissures； Score 1 indicates mild dryness, occasional scaling, uneven distribution, and slightly rough and dull skin appearance； Score 2 indicates moderate dryness, with small flakes or small patches of scales on the skin surface, and mildly rough and whitish appearance； Score 3 indicates severe dryness, with evenly distributed scales, a noticeably rough skin appearance, mild redness, and minor cracks； Score 4 indicates extremely severe dryness, with extensive scale shedding, a rough and reddened skin appearance accompanied by eczema-like changes and fissures.
Measured: Baseline visit, Week 4 visit
Changes in NRS scores before and after use of the trial product
The NRS itch score ranges from 0 (no itching) to 10 (severe itching). Clinicians ask participants to verbally express the severity of their subjective itching using numerical values. The following are reference values for the NRS itch score:
Score 0 indicates no itching Score 1-2 indicates mild itching Score 3-6 indicates moderate itching Score 7-8 indicates severe itching Score 9-10 indicates very severe itching
Measured: Baseline visit, Week 4 visit
Doctors assess the skin condition of participants by completing a scoring form
Doctors assess the skin condition of participants by completing a scoring form, which uses a 0-4 point scale (0 points indicating no symptoms, 4 points indicating severe symptoms). The form includes the following criteria: skin dryness, skin flaking/peeling/scaling, skin roughness, skin redness/erythema, skin cracking, and noticeable irritation caused by scratching.
Measured: Baseline visit, week 4 visit
Quality of life self-assessment questionnaire completed by subjects
Subjects completed a quality of life self-assessment questionnaire using a 1-4 point scale (1 point indicating none at all, 4 points indicating to a great extent), which included questions on whether subjects felt depressed, embarrassed, or stressed due to dry skin, and whether dry skin affected subjects' daily lives, social activities, etc.
Measured: Baseline visit, Week 4 visit
Secondary outcomes (3)
Doctors assess participants' tolerance and satisfaction with the trial product by completing a questionnaire
Doctors assess the trial product's tolerance by completing a questionnaire, which is a 1-4 point rating scale (1 = low, 4 = very high). Doctors assess overall satisfaction with the trial product by completing a questionnaire, which is a 1-5 point rating scale (1 = very dissatisfied, 5 = very satisfied).
Measured: Week 4 visit
Patient self-assessment questionnaire for tolerability and satisfaction with the investigational product
Patients assess the tolerability of the trial product by completing a questionnaire, which is a 1-4 point rating scale (1 = low, 4 = very high). Patients assess their overall satisfaction with the trial product by completing a questionnaire, which is a 1-5 point rating scale (1 = very dissatisfied, 5 = very satisfied).
Measured: Week 4 visit
Cosmetic characteristics questionnaire completed by patients
Patients complete a cosmetic characteristics questionnaire, which mainly includes questions about absorption, stickiness, smell, texture, feel, and whether it makes the skin feel comfortable. The questionnaire is scored on a scale of 1 to 5, with 1 = completely disagree and 5 = completely agree.
Measured: Week 4 vist
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Aug 2025
- Study start22 Aug 2025 (estimated)
- Primary completionNov 2025 (estimated)
- Study completionJan 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Dry Skin in the ElderlyStudies of the same condition, open and under way.
- More trials run by ChinaNormThe 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
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 210 participants (estimated)
Sponsor and investigators
- Lead sponsor
- ChinaNorm
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07133971
- Sponsor's protocol ID
- C25005056
- Status last verified
- Aug 2025
- First submitted
- 14 Aug 2025
- Last updated
- 21 Aug 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Clinical Observational Study Evaluating the Efficacy of Cerave Neuroceramide Intensive Repair Body Lotion in Improving Dry Skin in the Elderly
- ClinicalTrials.gov ID
- NCT07133971
- Acronym / sponsor ID
- C25005056
- Conditions
- Dry Skin in the Elderly
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 210 participants (estimated)
- Lead sponsor
- ChinaNormIndustry (pharma, biotech, devices)
- Study start
- 22 Aug 2025 (estimated)
- Primary completion
- Nov 2025 (estimated)
- Study completion
- Jan 2026 (estimated)
- First posted
- 21 Aug 2025 (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.
This study is a single-center observational clinical study aimed at evaluating the impact of Cerave Neuroceramide Moisturizing Repair Body Lotion on the quality of life, improvement in skin condition, and satisfaction with the product experience among individuals with moderate to severe dry skin associated with aging. The study plans to recruit approximately 210 male or female participants aged 55 years or older with moderate to severe skin dryness in the affected areas (accounting for a dropout rate and protocol violation rate of no more than 5%), and will screen participants based on inclusion and exclusion criteria to ensure that at least 200 participants complete the study. Participants entering this study will be categorized based on ODS and NRS scores into: moderate or severe skin dryness (moderate-grade 2, severe-grade 3), with the sample size ratio between moderate and severe groups maintained at 1:1. This study will last for 4 weeks and include 2 visits. Visits will be conducted at baseline (T0) and week 4 (T4w). The window period for the week 4 (T4w) visit is ±2 days. This study does not involve randomization. All study participants will use Cerave Neuroceramide Moisturizing Repair Body Lotion on areas of skin dryness.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients with moderate to severe skin dryness | – | Other: skin care product（Cerave Neuroceramide Moisturizing Repair Body Lotion）Based on ODS and NRS scores, patients with moderate to severe skin dryness (moderate-grade 2, severe-grade 3) were assessed. |
Who may qualify
- Ages
- 55 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Male or female study participants aged 55 years or older with moderate to severe skin dryness.
Key inclusion criteria (8 listed)
- Individuals with moderate to severe skin dryness as assessed by a clinician (ODS score of 2 or 3)
- Individuals with moderate to severe self-reported skin itching as assessed by a clinician (NRS ≥ 1)
- Individuals aged 55 years and older
- Open to patients with one or more of the following conditions:
- Voluntarily participate in the trial, understand and agree to sign the informed consent form, and agree to follow the study protocol throughout the study period, including using the study-provided products, not using other similar products, completing a diary, and attending regular follow-up visits as required by the trial.
Key exclusion criteria (5 listed)
- Individuals with a history of allergy, allergic reaction, or hypersensitivity to any component of the study product (Cerave Neuroceramide Moisturizing Repair Body Lotion);
- Individuals with a history of allergic contact dermatitis secondary to the use of moisturizing products;
- Individuals with any clinical manifestations or other conditions at the treatment site that the physician deems may affect the evaluation or results of the study product;
- Individuals who are unable or unwilling to attend all study visits and adhere to the treatment regimen;
- Individuals who have participated in any other drug clinical studies within the past 3 months prior to the start of the trial.
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 |
|---|---|---|
| skin care product（Cerave Neuroceramide Moisturizing Repair Body Lotion）All study participants will use Cerave Neuroceramide Moisturizing Body Lotion during the trial period, applying it every night to dry skin areas. If topical medications are used, they should be applied first to dry skin areas, followed by the product. | Other | Patients with moderate to severe skin dryness |
Primary outcome
Changes in ODS grading before and after using the trial product
Time frame: Baseline visit, Week 4 visit
The Overall Dry Skin Score (ODS) is used to comprehensively assess the severity of objective findings of skin dryness. The following are the skin manifestations and scores for ODS grading: A score of 0 indicates no dryness symptoms, smooth skin, no scaling, no roughness, no erythema, and no fissures； Score 1 indicates mild dryness, occasional scaling, uneven distribution, and slightly rough and dull skin appearance； Score 2 indicates moderate dryness, with small flakes or small patches of scales on the skin surface, and mildly rough and whitish appearance； Score 3 indicates severe dryness, with evenly distributed scales, a noticeably rough skin appearance, mild redness, and minor cracks； Score 4 indicates extremely severe dryness, with extensive scale shedding, a rough and reddened skin appearance accompanied by eczema-like changes and fissures.
Changes in NRS scores before and after use of the trial product
Time frame: Baseline visit, Week 4 visit
The NRS itch score ranges from 0 (no itching) to 10 (severe itching). Clinicians ask participants to verbally express the severity of their subjective itching using numerical values. The following are reference values for the NRS itch score: Score 0 indicates no itching Score 1-2 indicates mild itching Score 3-6 indicates moderate itching Score 7-8 indicates severe itching Score 9-10 indicates very severe itching
Doctors assess the skin condition of participants by completing a scoring form
Time frame: Baseline visit, week 4 visit
Doctors assess the skin condition of participants by completing a scoring form, which uses a 0-4 point scale (0 points indicating no symptoms, 4 points indicating severe symptoms). The form includes the following criteria: skin dryness, skin flaking/peeling/scaling, skin roughness, skin redness/erythema, skin cracking, and noticeable irritation caused by scratching.
Quality of life self-assessment questionnaire completed by subjects
Time frame: Baseline visit, Week 4 visit
Subjects completed a quality of life self-assessment questionnaire using a 1-4 point scale (1 point indicating none at all, 4 points indicating to a great extent), which included questions on whether subjects felt depressed, embarrassed, or stressed due to dry skin, and whether dry skin affected subjects' daily lives, social activities, etc.
3 secondary outcomes
Doctors assess participants' tolerance and satisfaction with the trial product by completing a questionnaire
Time frame: Week 4 visit
Patient self-assessment questionnaire for tolerability and satisfaction with the investigational product
Time frame: Week 4 visit
Cosmetic characteristics questionnaire completed by patients
Time frame: Week 4 vist
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 21 Aug 2025.
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Dry Skin in the Elderly, run by ChinaNorm.
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 8 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: opening soon, as of the sponsor's last update on 21 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
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.
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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes in ODS grading before and after using the trial product (time frame: Baseline visit, Week 4 visit). The study lists 4 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 21 Aug 2025.