Evaluation of the Effect of Combined Use of Cosmetic Products for Dry and Itchy Skin.

Официальное название

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

Обзор

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

Вмешательства

• Другое Shower oleogel and body lotion
  Daily use of shower oleogel and body lotion for 28 days
• Другое Shower gel and body lotion
  Daily use of shower gel and body lotion

Первичные конечные точки

• Change from Baseline in the rate of skin hydration (capacitance measured by Corneometer) at 4 weeks [Срок оценки: From enrollment to the end of the study at 4 weeks]

Вторичные конечные точки (1)

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

Критерии участия

Критерии включения

• 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.

Критерии исключения

• 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

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

Здоровые добровольцы: Да

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Двойное слепое

Основная цель

Другое

Центры проведения

Португалия · 1 центр

• PhD Trials — Lisbon

Идентификаторы

NCT: NCT07695805 · PhDES2851B

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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