Instant Flush Redness Clinical Efficacy Study

N/ANot Yet RecruitingNCT07067476

ChinaNorm60 enrolled

Overview

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

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

Conditions

Sensitive Skin

Interventions

Eligibility

Sex: FEMALEMin age: 20 YearsMax age: 40 YearsHealthy volunteers:

Medical Language ↔ Plain English

Inclusion Criteria: 1. Chinese women aged from 20-40 years old. 2. Self-declared mild sensitive skin. 3. Self-declare with skin concerns of redness and easy to flush. 4. Willing to be exposed to infrared light on the facial skin to induce facial redness(can tolerate heat sensation on the face). 5. Clinical grading of skin redness (visual) ≥ 4 after infrared light induction (7-8 mins) by dermatologist. 6. No disagreement of dermatologist because of other reasons that exclude the parficipation of the subject. 7. In general good health at the time of the study. 8. Willing and able to participate as evidenced by signing of informed consent and photo release Exclusion Criteria: 1. Allergic to infrared light 2. Pregnant or breast-feeding woman or woman planning pregnancy during the study. 3. Subject deprived of rights by a court or administrative order. 4. Major subject to a guardianship order. 5. Subject residing in a health or social care establishment. 6. Patient in an emergency setting 7. Subject with a skin disease in the test areas (particularly e.g, acne, rosacea, eczema). 8. Subjects with history, of atopy, allergic reactions, irritation or intense discomfort feelings to topical-use products, medication, cosmetic: or personal care products or ingredients. 9. Subject presenting a stable or progressive serious disease (per investigator's assessment). 10. Immuno-compromised subject. 11. Subject presenting excessive exposure to sunlight or UV radiation (investigator's assessment). 12. Subjects regularly practicing aquatic or nautical sports. 13. Subjects regularly attending a sauna. 14. Subject with cardiovascular or circulatory history. 15. Subject with a history of skin cancer or malignant melanoma. 16. Intake of antihistamines, antibiotics, corticosteroids, non-steroidal anti-inflammatories or immune-suppressants in the last 6 months before study.

Outcomes

Primary Outcomes

Change in skin redness visual score (Griffith 10-point scale)

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).