Instant Flush Redness Clinical Efficacy Study
ConditionSensitive Skin
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age20-40
SponsorChinaNorm
About this trial
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
Eligibility criteria
This trial accepts healthy volunteersQualifiers
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).
Disqualifiers
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.
Trial design
Design model
Crossover
Treatments tested in this trial
Instant Anti-Redness Emulsion (FLA#2039188 43)
Other interventionA 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 intervention0.3g 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.
Treatment groups
60 Participants
are divided into 2 treatment groupsGroup A: Test Side: Instant Anti-Redness EmulsionExperimental treatment 1 intervention
Group B: Control Side: Water OnlyPlacebo comparator 1 intervention
Trial outcomes
Primary outcomes
1
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).
Time frame
Baseline to 2 hours post-applicationSecondary outcomes
1
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.
Time frame
Baseline to 2 hours post-application2
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.
Time frame
Baseline to 2 hours post-application3
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.
Time frame
Baseline to 2 hours post-application4
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.
Time frame
Baseline to 2 hours post-application Source ClinicalTrials.gov
This trial is not recruiting at the moment. You can still explore other options: