Serum Instant Anti-Redness Efficacy Clinical Study

ChinaNorm

Status: Completed

Conditions: Female; Redness

Treatments: Other: Investigational Serum, Standard Cleanser; Device: Infrared Light for Redness Induction on Face

Study type: Interventional

Funder types: Industry

Identifiers

NCT07058701

C24005025

Details and patient eligibility

About

This study is a mono-centric, om-site use, random half-face application, blank control study. 64 female adult subjects will be enrolled and divided into 2 groups in the study, recruited according to inclusion and non-inclusion criteria listed above. At least 30 subjects for each group should complete the test in this 1 visit study.

Enrollment: 65 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. Regular users of cleanser, Serum, moisturizer and sunscreen product.
4. Self-declare with skin concerns of redness and easy to flushing.
5. Willing to be exposed to infrared light on the facial skin to induce facial redness (can tolerate heat sensation on the face).
6. Clinical grading of skin redness(visual) ≥ 4 after infrared light[2] induction (5-10 mins) by dermatologist.
7. No disagreement of dermatologist because of other reasons that exclude the participation of the subject.
8. In general good health at the time of the study.
9. Willing and able to participate as evidenced by signing of informed consent and photo release form.
10. Must be willing to comply with all study protocol requirements (pay attention to: only use the provided product during the study, not take topical or oral treatment like retinol, hormone, anti-oxidant health-care products which may impact the efficacy of study).

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: Other

Allocation: Randomized

Interventional model: Single Group Assignment

Masking: Triple Blind

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65 participants in 2 patient groups

Group Serum

Other group

Treatment:

Device: Infrared Light for Redness Induction on Face

Other: Investigational Serum, Standard Cleanser

Group Blank

Other group

Treatment:

Device: Infrared Light for Redness Induction on Face