Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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:
Researchers will compare the anti-redness emulsion to purified water using a split-face method.
Participants will:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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). | Baseline to 2 hours post-application |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Baseline to 2 hours post-application |
| Change in erythema index (Mexameter® MX 18) |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Shanghai China-norm Quality Technical Service Co., Ltd., Shanghai, Shanghai 200072 | Shanghai | China |
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.
18-Month Duration: The data sharing period starts upon study completion and PRS registration completion.
Timeline:
Months 2-3: Data de-identification, metadata preparation, and platform integration.
Month 4: Official launch of data access.
Primary Platform:
ResMan (www.medresman.org.cn) - China's leading medical research data repository.
Eligibility:
Researchers/affiliates from academic institutions, hospitals, or registered research organizations.
Engaged in dermatology, cosmetic science, or related fields. Able to demonstrate ethical compliance and data security capabilities.
Not provided
Not provided
Not provided
Not provided
Not provided
| 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. |
|
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. |
| 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. | 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. | 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. | 15 minutes post-application |