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NCT Number: NCT07067476

Instant Flush Redness Clinical Efficacy Study

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

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Key information

Conditions

Age range

20 year–40 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

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

Shanghai, China

Location contact

Yanwen Jiang

CONTACT

[email protected]

+86 13501700841

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • 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.

Treatment and study plan

Instant Anti-Redness Emulsion (FLA#2039188 43)

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.

Purified Water (Control)

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.

Primary outcomes

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

    Time frame: 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).

Secondary outcomes

  1. Change in facial redness area ratio (Visia 7 image analysis)

    Time frame: Baseline to 2 hours post-application

    Standard and polarized images of the face will be captured by Visia 7. The red area ratio will be calculated from red mode images before and after product application.

  2. Change in erythema index (Mexameter® MX 18)

    Time frame: Baseline to 2 hours post-application

    Erythema index will be measured based on spectral absorption at both sides of the cheeks. Measurements will be taken at Tbefore, T0, T10min, T1h, and T2h.

  3. Change in red blood cell (RBC) concentration measured by TiVi 700

    Time frame: Baseline to 2 hours post-application

    The TiVi 700 Tissue Viability Imaging System will be used to assess RBC concentration in the facial skin as a marker of microcirculation. Measurements will be taken before and after infrared induction and at multiple timepoints after product application.

  4. Change in facial skin temperature measured by thermal imaging (Fluke TiS60+)

    Time frame: Baseline to 2 hours post-application

    Thermal images of both sides of the cheek will be captured by Fluke TiS60+ to evaluate skin temperature changes in response to product application. Images will be taken at multiple timepoints from before infrared induction to 2 hours post-application.

  5. Subject self-assessment of product efficacy and tolerance

    Time frame: 15 minutes post-application

    Participants will complete self-assessment questionnaires 15 minutes after product application to evaluate perceived product efficacy and tolerance, including redness reduction and skin comfort.

Sponsors and collaborators

Lead sponsor

ChinaNorm

Industry

Registry information

Official study title

A Randomized, Double-Blind, Split-Face Clinical Study to Evaluate the Redness Relief Efficacy of Instant Flush Products in Subjects With Sensitive Skin

Important dates

Study start
2025
Primary completion
2025
Study completion
2025
First posted
Jul 16, 2025
Registry last updated
Jul 16, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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