Instant Flush Redness Clinical Efficacy Study

NCT07067476 | Not Yet Recruiting DMC

• 1 other identifier: C25005021
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief 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 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

Outcome Measures

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).

  Baseline to 2 hours post-application

Secondary Outcomes (5)

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

  Baseline to 2 hours post-application

• Change in erythema index (Mexameter® MX 18)

  Baseline to 2 hours post-application

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

  Baseline to 2 hours post-application

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

  Baseline to 2 hours post-application

• Subject self-assessment of product efficacy and tolerance

  15 minutes post-application

Study Arms (2)

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.

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.

Other: Purified Water (Control)

Interventions

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.

Test Side: Instant Anti-Redness Emulsion

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.

Control Side: Water Only

Eligibility Criteria

• Age: 20 Years - 40 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• ChinaNorm: lead

Study Sites (1)

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

Shanghai, China

Location

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 3, 2025
• First Posted: July 16, 2025
• Study Start: July 15, 2025
• Primary Completion: October 15, 2025
• Study Completion: October 31, 2025
• Last Updated: July 16, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
• Time Frame: 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.
• Access Criteria: 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.

Locations

CN (1)