临床试验/NCT07695805

NCT07695805尚未招募不适用

Confirmation in Human Subjects of a Cosmetic Product Efficacy After Application in the Body Under Normal Conditions of Use.

Lacer S.A.1 个研究点分布在 1 个国家目标入组 60 人开始时间: 2026年7月1日最近更新: 2026年7月10日

适应症

试验速览

阶段: 不适用
状态: 尚未招募
发起方
入组人数: 60
试验地点: 1
主要终点: Change from Baseline in the rate of skin hydration (capacitance measured by Corneometer) at 4 weeks

研究概览研究设计入排标准结局指标研究者研究点记录与标识符相似试验

研究概览

简要总结

The goal of this study is to learn if combined use of shower oleogel and body lotion works to improve skin itching and dryness in adults. It will also learn about its safety. The main question it aims to answer is:

• Does the products use improves skin hydration and itching? Researchers will compare shower oleogel and body lotion to a commercially available shower gel and the body lotion to see if the combined use is more efficient than use of body lotion alone.

Participants will:

Use assigned products every day for 1 month
Visit the CRO for checkups and tests on established schedule

研究设计

研究类型: Interventional
分配方式: Randomized
干预模型: Parallel
主要目的: Other
盲法: Double (Participant, Outcomes Assessor)

入排标准

年龄范围: 18 Years 至 70 Years（Adult, Older Adult）
性别: All
接受健康志愿者: 是

入选标准

•Age: 18-70 years old
•Gender: both
•Sensitive skin and 30% to 50% with atopic tendency (scored 8-12)
•With dry or very dry skin on the body
•With presence of itching due to different origins: contact/friction with fabrics, hard water, atopic tendency, dry skin, etc.

排除标准

•cutaneous marks on the experimental areas, which could interfere with the assessment of skin reactions (pigmentation troubles, scar elements, over-developed pilosity, ephelides and naevi in too great quantity, sunburn),
•allergy or reactivity to products of the same category than the tested one,
•with history of malignant melanomas (Dubreullh melanosis…)
•unbalanced hormonal treatment,
•forecast of initiation of an hormonal treatment or change of the usual hormonal treatment during the study or 3 months before the starting of the study,
•forecast of intensive sun or UVA exposure (UV lamps) during the test period,
•breast-feeding or pregnancy,
•treatment with Vitamin A acid or its derivatives stopped less than 3 months before the beginning of the study,
•treatment with anti-stretch, firming, slimming or anti-cellulite products stopped less than 3 months before the beginning of the study,
•diet stopped less than 3 months before the beginning of the study,
•drugs likely to produce an increase or reduction in body weight,
•under anti-cellulite treatment: mesotherapy, electrotherapy, ionisation, ultrasonotherapy, relaxation, acupuncture, hydrotherapy, lymphatic drainage, massage, sauna,…,
•neither antibiotic, anti-allergic, anti-inflammatory treatment nor treatment with patent medicines containing Vitamin A acid or its derivatives before and during the study (if therapeutic requirement: exclusion foreseen),
•systemic disorders: Cardiovascular, pulmonary, digestive, neurologic, psychiatric, genital, urinary, haematological, endocrine
•individuals who have undergone a bilateral mastectomy with lymph node removal, a unilateral mastectomy with lymph node removal within the last year, or a bilateral axillary lymph node removal,
•individuals with a history of immune deficiency or auto-immune disease, treated for malignancy within 6 months prior to enrollment or who are currently under treatment for asthma or diabetes,
•forecast of vaccination during the test period or last vaccination within 3 weeks before the study

结局指标

主要结局

Change from Baseline in the rate of skin hydration (capacitance measured by Corneometer) at 4 weeks

时间窗: From enrollment to the end of the study at 4 weeks

次要结局

Change from Baseline in the rate of skin barrier function (TEWL evaluated by Tewameter) at 4 weeks.(From enrollment to the end of the study at 4 weeks)

研究者

发起方

Lacer S.A.

申办方类型

Industry

责任方

Sponsor

研究点 (1)

Loading locations...

相似试验

已完成

不适用

Evaluation of Hydrating Cream Effect on Subjects With Dry Skin.

NCT07393191Lacer S.A.35

尚未招募

不适用

Evaluation of skin benefits of the test products

CTRI/2025/02/080265Innovantase Research and development services LLP LLP33

招募中

不适用

The Effect of Cosmetic Formulations on the Appearance of Grey Hair.

NCT07280676Unilever R&D380

尚未招募

不适用

A study to see how a skincare product reduces tan, improves brightness, skin tone, hydration, and smoothness.

CTRI/2026/02/104789YMI gharsoaps pvt ltd36

Unknown

不适用

产品及护肤品（内服外用）人体功效评价研究

ChiCTR2400085413安利（上海）科技发展有限公司