Instant Flush Redness Clinical Efficacy Study

NCT ID: NCT07067476

Last Updated: 2025-07-16

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

NA

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-07-15

Study Completion Date

2025-10-31

Brief Summary

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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

Detailed Description

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Conditions

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Sensitive Skin

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Test Side: Instant Anti-Redness Emulsion

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.

Group Type EXPERIMENTAL

Instant Anti-Redness Emulsion (FLA#2039188 43)

Intervention Type OTHER

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.

Control Side: Water Only

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.

Group Type PLACEBO_COMPARATOR

Purified Water (Control)

Intervention Type OTHER

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.

Interventions

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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.

Intervention Type OTHER

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.

Intervention Type OTHER

Eligibility Criteria

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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.
Minimum Eligible Age

20 Years

Maximum Eligible Age

40 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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ChinaNorm

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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

Shanghai, , China

Site Status

Countries

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China

Facility Contacts

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Yanwen Jiang

Role: primary

+86 13501700841

Other Identifiers

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C25005021

Identifier Type: -

Identifier Source: org_study_id

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