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

Официальное название

A Clinical Observational Study Evaluating the Efficacy of Cerave Neuroceramide Intensive Repair Body Lotion in Improving Dry Skin in the Elderly

Обзор

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.

Вмешательства

• Другое 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.

Первичные конечные точки

• Changes in ODS grading before and after using the trial product [Срок оценки: Baseline visit, Week 4 visit]
• Changes in NRS scores before and after use of the trial product [Срок оценки: Baseline visit, Week 4 visit]
• Doctors assess the skin condition of participants by completing a scoring form [Срок оценки: Baseline visit, week 4 visit]
• Quality of life self-assessment questionnaire completed by subjects [Срок оценки: Baseline visit, Week 4 visit]

Вторичные конечные точки (3)

• Doctors assess participants' tolerance and satisfaction with the trial product by completing a questionnaire [Срок оценки: Week 4 visit]
• Patient self-assessment questionnaire for tolerability and satisfaction with the investigational product [Срок оценки: Week 4 visit]
• Cosmetic characteristics questionnaire completed by patients [Срок оценки: Week 4 vist]

Критерии участия

Критерии включения

• 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.

Критерии исключения

• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Дизайн исследования

Модель наблюдения

Только случаи

Центры проведения

Список центров уточняется — проверьте первичный протокол.

Идентификаторы

NCT: NCT07133971 · C25005056

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗