NCT07067476尚未招募不适用
A Randomized, Double-Blind, Split-Face Clinical Study to Evaluate the Redness Relief Efficacy of Instant Flush Products in Subjects With Sensitive Skin
ChinaNorm1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2025年7月15日最近更新:
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 in skin redness visual score (Griffith 10-point scale)
研究概览
简要总结
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
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 20 Years 至 40 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •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
排除标准
- •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.
结局指标
主要结局
Change in skin redness visual score (Griffith 10-point scale)
时间窗: Baseline to 2 hours post-application
Skin redness will be assessed by a dermatologist using the Griffith visual 10-point scale on the left and right sides of the face. Higher scores on the Griffith 10-point scale indicate greater skin redness, which is considered a worse outcome. Assessments will occur at Tbefore (before infrared induction), T0 (after infrared induction), T10min (10 mins post-application), T1h (1 hour post-application), and T2h (2 hours post-application).
次要结局
- Change in facial redness area ratio (Visia 7 image analysis)(Baseline to 2 hours post-application)
- Change in erythema index (Mexameter® MX 18)(Baseline to 2 hours post-application)
- Change in red blood cell (RBC) concentration measured by TiVi 700(Baseline to 2 hours post-application)
- Change in facial skin temperature measured by thermal imaging (Fluke TiS60+)(Baseline to 2 hours post-application)
- Subject self-assessment of product efficacy and tolerance(15 minutes post-application)
研究者
研究点 (1)
Loading locations...
相似试验
已完成
2 期
Efficacy of Eflornithine Hydrochloride Cream in the Treatment of Melasma: A Randomized, Double-blinded, Split-face Controlled StudyNCT06957834National Skin Centre20
已完成
不适用
Effect of Fasting-Mimicking Diet on Skin HealthSkinNCT05564624L-Nutra Inc45
已完成
不适用
Clinical Study for the Efficacy Evaluation of a Food SupplementSpot PigmentedWrinkleNCT06453837Mibelle Group Biochemistry110
已完成
不适用
Facial Skin Clinical and Microbial Profiling From Oral Probiotic SupplementationHealthySkin ManifestationsNCT05597254Oriflame Cosmetics AB109
已完成
不适用
Placebo-Controlled Study Assessing the Use of a Novel Exfoliative Serum With A Chemical Peel to Improve Photodamage in AdultsPhotodamaged SkinNCT05908825Austin Institute for Clinical Research34