A Clinical Observational Study Evaluating the Efficacy of Cerave Neuroceramide Intensive Repair Body Lotion .

ChinaNorm

Status: Not yet enrolling

Conditions: Dry Skin in the Elderly

Treatments: Other: skin care product（Cerave Neuroceramide Moisturizing Repair Body Lotion）

Study type: Observational

Funder types: Industry

Identifiers

NCT07133971

C25005056

Details and patient eligibility

About

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.

Enrollment: 210 estimated patients

Sex: All

Ages: 55+ years old

Volunteers: No Healthy Volunteers

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:

  1. History of atopic dermatitis;
  2. 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.);
  3. 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.

Trial design

210 participants in 1 patient group

Patients with moderate to severe skin dryness

Description:

Based on ODS and NRS scores, patients with moderate to severe skin dryness (moderate-grade 2, severe-grade 3) were assessed.

Treatment:

Other: skin care product（Cerave Neuroceramide Moisturizing Repair Body Lotion）