Instant Flush Redness Clinical Efficacy Study

ChinaNorm

Status: Not yet enrolling

Conditions: Sensitive Skin

Treatments: Other: Purified Water (Control); Other: Instant Anti-Redness Emulsion (FLA#2039188 43)

Study type: Interventional

Funder types: Industry

Identifiers

NCT07067476

C25005021

Details and patient eligibility

About

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

Enrollment: 60 estimated patients

Sex: Female

Ages: 20 to 40 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Quadruple Blind

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60 participants in 2 patient groups, including a placebo group

Test Side: Instant Anti-Redness Emulsion

Experimental group

Description:

Participants will receive 0.3g of test emulsion (FLA#2039188 43) applied to one half of their face. The emulsion contains panthenol (Vitamin B5 precursor) and is designed to reduce facial redness after infrared heat-induced stimulation.

Treatment:

Other: Instant Anti-Redness Emulsion (FLA#2039188 43)

Control Side: Water Only

Placebo Comparator group

Description:

Participants will receive 0.3g of purified water applied to the opposite side of the face, serving as control. Redness relief will be compared between the test emulsion and water using clinical assessment and imaging tools.

Treatment:

Other: Purified Water (Control)