A Clinical Observational Study Evaluating the Efficacy of Cerave Neuroceramide Intensive Repair Body Lotion .
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: skin care product（Cerave Neuroceramide Moisturizing Repair Body Lotion）.
- Who it may be relevant to
- Registry conditions: Dry Skin in the Elderly. Basic parameters: from 55 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Center list to be confirmed — check the primary protocol.
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
A Clinical Observational Study Evaluating the Efficacy of Cerave Neuroceramide Intensive Repair Body Lotion in Improving Dry Skin in the Elderly
Overview
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.
Interventions
- Other 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.
Primary outcome measures
- Changes in ODS grading before and after using the trial product [Time frame: Baseline visit, Week 4 visit]
- Changes in NRS scores before and after use of the trial product [Time frame: Baseline visit, Week 4 visit]
- Doctors assess the skin condition of participants by completing a scoring form [Time frame: Baseline visit, week 4 visit]
- Quality of life self-assessment questionnaire completed by subjects [Time frame: Baseline visit, Week 4 visit]
Secondary outcome measures (3)
- 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]
Eligibility criteria
Inclusion criteria
- 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.
Exclusion criteria
- 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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Study design
- Observational model
- Case-only
Study locations
Center list to be confirmed — check the primary protocol.
Identifiers
NCT: NCT07133971 · C25005056