Instant Flush Redness Clinical Efficacy Study

Официальное название

A Randomized, Double-Blind, Split-Face Clinical Study to Evaluate the Redness Relief Efficacy of Instant Flush Products in Subjects With Sensitive Skin

Обзор

The goal of this clinical trial is to learn if an anti-redness emulsion can help lower facial redness caused by heat in healthy adult women. The main questions it aims to answer are: * Does the anti-redness emulsion lower facial redness better than purified water? * Is the product safe and comfortable to use? Researchers will compare the anti-redness emulsion to purified water using a split-face method. Participants will: * Receive infrared light on their face to trigger redness * Apply the anti-redness emulsion to one side of their face and purified water to the other side * Have their facial redness measured at different time points using photography, imaging devices, and skin redness tests * Answer questions about their experience with the products

Вмешательства

• Другое Instant Anti-Redness Emulsion (FLA#2039188 43)
  A topical emulsion not yet marketed, developed to relieve skin redness. It contains panthenol and is applied once to the test side of the face after heat-induced redness.
• Другое Purified Water (Control)
  0.3g of water is applied to the control side of the face. Used as placebo comparator to evaluate the redness-relieving efficacy of the test emulsion.

Первичные конечные точки

• Change in skin redness visual score (Griffith 10-point scale) [Срок оценки: Baseline to 2 hours post-application]

Вторичные конечные точки (5)

• Change in facial redness area ratio (Visia 7 image analysis) [Срок оценки: Baseline to 2 hours post-application]
• Change in erythema index (Mexameter® MX 18) [Срок оценки: Baseline to 2 hours post-application]
• Change in red blood cell (RBC) concentration measured by TiVi 700 [Срок оценки: Baseline to 2 hours post-application]
• Change in facial skin temperature measured by thermal imaging (Fluke TiS60+) [Срок оценки: Baseline to 2 hours post-application]
• Subject self-assessment of product efficacy and tolerance [Срок оценки: 15 minutes post-application]

Критерии участия

Критерии включения

• Chinese women aged from 20-40 years old.
• Self-declared mild sensitive skin.
• Self-declare with skin concerns of redness and easy to flush.
• Willing to be exposed to infrared light on the facial skin to induce facial redness(can tolerate heat sensation on the face).
• Clinical grading of skin redness (visual) ≥ 4 after infrared light induction (7-8 mins) by dermatologist.
• No disagreement of dermatologist because of other reasons that exclude the parficipation of the subject.
• In general good health at the time of the study.
• Willing and able to participate as evidenced by signing of informed consent and photo release

Критерии исключения

• Allergic to infrared light
• Pregnant or breast-feeding woman or woman planning pregnancy during the study.
• Subject deprived of rights by a court or administrative order.
• Major subject to a guardianship order.
• Subject residing in a health or social care establishment.
• Patient in an emergency setting
• Subject with a skin disease in the test areas (particularly e.g, acne, rosacea, eczema).
• Subjects with history, of atopy, allergic reactions, irritation or intense discomfort feelings to topical-use products, medication, cosmetic: or personal care products or ingredients.
• Subject presenting a stable or progressive serious disease (per investigator's assessment).
• Immuno-compromised subject.
• Subject presenting excessive exposure to sunlight or UV radiation (investigator's assessment).
• Subjects regularly practicing aquatic or nautical sports.
• Subjects regularly attending a sauna.
• Subject with cardiovascular or circulatory history.
• Subject with a history of skin cancer or malignant melanoma.
• Intake of antihistamines, antibiotics, corticosteroids, non-steroidal anti-inflammatories or immune-suppressants in the last 6 months before study.

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

Здоровые добровольцы: Да

Дизайн исследования

Распределение

Рандомизированное

Модель

Перекрёстный дизайн

Маскирование

Четверное слепое

Основная цель

Лечение

Центры проведения

Китай · 1 центр

• Shanghai China-norm Quality Technical Service Co., Ltd., Shanghai, Shanghai 200072 — Шанхай

Идентификаторы

NCT: NCT07067476 · C25005021

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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