Sensitive SkinNCT07067476
Instant Flush Redness Clinical Efficacy Study
A study testing Instant Anti-Redness Emulsion (FLA#2039188 43) in people with Sensitive Skin, run by ChinaNorm at 1 site in China.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 20 to 40 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Sensitive Skin
- What is being tested?
- Instant Anti-Redness Emulsion (FLA#2039188 43)
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 1 siteChina
- Study dates
- 15 Jul 2025to 31 Oct 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 40 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 16Show fewer
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site
Shanghai China-norm Quality Technical Service Co., Ltd., Shanghai, Shanghai 200072
Shanghai
Yanwen Jiang, +86 13501700841, jiangyanwen@china-norm.com
About this study
Official title: A Randomized, Double-Blind, Split-Face Clinical Study to Evaluate the Redness Relief Efficacy of Instant Flush Products in Subjects With Sensitive Skin
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?
Read more
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
- Conditions
- Sensitive Skin
- Being tested
- Instant Anti-Redness Emulsion (FLA#2039188 43), Purified Water (Control)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
| Study group | Role | What they receive |
|---|---|---|
| Test Side: Instant Anti-Redness Emulsion | Experimental | 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. Receives: Other: Instant Anti-Redness Emulsion (FLA#2039188 43) |
| Control Side: Water Only | Placebo comparator | 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. Receives: Other: Purified Water (Control) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: Baseline to 2 hours post-application
Secondary outcomes (5)
Change in facial redness area ratio (Visia 7 image analysis)
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.
Measured: Baseline to 2 hours post-application
Change in erythema index (Mexameter® MX 18)
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.
Measured: Baseline to 2 hours post-application
Change in red blood cell (RBC) concentration measured by TiVi 700
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.
Measured: Baseline to 2 hours post-application
Change in facial skin temperature measured by thermal imaging (Fluke TiS60+)
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.
Measured: Baseline to 2 hours post-application
Subject self-assessment of product efficacy and tolerance
Participants will complete self-assessment questionnaires 15 minutes after product application to evaluate perceived product efficacy and tolerance, including redness reduction and skin comfort.
Measured: 15 minutes post-application
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jul 2025
- Study start15 Jul 2025 (estimated)
- Primary completion15 Oct 2025 (estimated)
- Study completion31 Oct 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Sensitive SkinStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- ChinaNorm
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07067476
- Sponsor's protocol ID
- C25005021
- Status last verified
- Jul 2025
- First submitted
- 3 Jul 2025
- Last updated
- 16 Jul 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: This Data Sharing Plan (DSP) aims to promote the open exchange and reuse of de-identified individual participant data (IPD) from cosmetic clinical research, including study protocols, case report forms (CRFs), and statistical analysis plans (SAPs). The shared data will be made available through compliant platforms to eligible researchers in dermatology, cosmetic science, and related fields, following ethical principles and data protection regulations. Users must sign a Data Use Agreement (DUA) to ensure data security, privacy protection, and compliance with research purposes.
Study at a glance
From the registry record, last updated by the sponsor on 16 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-Blind, Split-Face Clinical Study to Evaluate the Redness Relief Efficacy of Instant Flush Products in Subjects With Sensitive Skin
- ClinicalTrials.gov ID
- NCT07067476
- Acronym / sponsor ID
- C25005021
- Conditions
- Sensitive Skin
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- ChinaNormIndustry (pharma, biotech, devices)
- Study start
- 15 Jul 2025 (estimated)
- Primary completion
- 15 Oct 2025 (estimated)
- Study completion
- 31 Oct 2025 (estimated)
- First posted
- 16 Jul 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Test Side: Instant Anti-Redness Emulsion | Experimental | Other: Instant Anti-Redness Emulsion (FLA#2039188 43)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. |
| Control Side: Water Only | Placebo comparator | Other: Purified Water (Control)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. |
Who may qualify
- Ages
- 20 to 40 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (8 listed)
- 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.
Key exclusion criteria (16 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Other | Test Side: Instant Anti-Redness Emulsion |
| 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. | Other | Control Side: Water Only |
Primary outcome
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).
5 secondary outcomes
Change in facial redness area ratio (Visia 7 image analysis)
Time frame: Baseline to 2 hours post-application
Change in erythema index (Mexameter® MX 18)
Time frame: Baseline to 2 hours post-application
Change in red blood cell (RBC) concentration measured by TiVi 700
Time frame: Baseline to 2 hours post-application
Change in facial skin temperature measured by thermal imaging (Fluke TiS60+)
Time frame: Baseline to 2 hours post-application
Subject self-assessment of product efficacy and tolerance
Time frame: 15 minutes post-application
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Jul 2025.
- Individual participant dataSharing planned: Yes. This Data Sharing Plan (DSP) aims to promote the open exchange and reuse of de-identified individual participant data (IPD) from cosmetic clinical research, including study protocols, case report forms (CRFs), and statistical analysis plans (SAPs). The shared data will be made available through compliant platforms to eligible researchers in dermatology, cosmetic science, and related fields, following ethical principles and data protection regulations. Users must sign a Data Use Agreement (DUA) to ensure data security, privacy protection, and compliance with research purposes.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Shanghai China-norm Quality Technical Service Co., Ltd., Shanghai, Shanghai 200072
Shanghai, China
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Instant Anti-Redness Emulsion (FLA#2039188 43) in people with Sensitive Skin, run by ChinaNorm at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 16 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in skin redness visual score (Griffith 10-point scale) (time frame: Baseline to 2 hours post-application). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Jul 2025.