Serum Instant Anti-Redness Efficacy Clinical Study

NCT07058701 | Completed

• 1 other identifier: C24005025
• Study Type: interventional
• Target: 65
• Locations: 1 country
• Sites: 1

Brief Summary

This study is a mono-centric, om-site use, random half-face application, blank control study. 64 female adult subjects will be enrolled and divided into 2 groups in the study, recruited according to inclusion and non-inclusion criteria listed above. At least 30 subjects for each group should complete the test in this 1 visit study.

Conditions

Female; Redness

Outcome Measures

Primary Outcomes (6)

• Clinical scoring for skin redness

  Participants: N= 30

  Baseline, Time point post-induction 5 min , Time point post-intervention 5 min，Time point post-intervention 1 hour, Time point post-intervention 2 hours.

• Clinical scoring for skin redness

  Participants: N= 30

  Baseline, Time point post-induction 5 min.

• Image Capture and Analysis（Redness area ratio）

  Participants: N= 30，by VISIA 7

  Baseline, Time point post-induction 5 min , Time point post-intervention 5 min，Time point post-intervention 1 hour, Time point post-intervention 2 hours.

• Image Capture and Analysis（Redness area ratio）

  Participants: N= 30,by TiVi 700 Tissue Viability Imager

  Baseline, Time point post-induction 5 min , Time point post-intervention 5 min，Time point post-intervention 1 hour, Time point post-intervention 2 hours.

• Instrumental Assessment (Erythema index)

  Participants: N= 30, by Mexameter

  Baseline, Time point post-induction 5 min , Time point post-intervention 5 min，Time point post-intervention 1 hour, Time point post-intervention 2 hours.

• Consumer Questionnaire

  Participants: N= 60

  Time point post-intervention 10 sec, Time point post-intervention 1 min, Time point post-intervention 5 min，Time point post-intervention 1 hour, Time point post-intervention 2 hours.

Study Arms (2)

Group Serum

OTHER

Other: Investigational Serum, Standard Cleanser; Device: Infrared Light for Redness Induction on Face

Group Blank

OTHER

Device: Infrared Light for Redness Induction on Face

Interventions

Investigational Serum, Standard Cleanser OTHER

Mode of Group Serum application : On-site single use Standard cleanser + Investigational Serum (random half-face) \[FLA #2039128 50\] \- subjects should wash face with standard cleanser \[FLA #730457 36\] on site before measurements. The technician will apply the Investigational Serum \[FLA #2039128 50\] on the subject's half face (according to the Annex 11.6) at the test site, keep another half face as blank control.

Group Serum

Infrared Light for Redness Induction on Face DEVICE

Infrared light has high radiation frequency, its permeability is strong, the wavelength of infrared light can penetrate the human dermis to promote blood circulation and induce skin redness.The redness induction process will be done after baseline measurements for each subject.The subject's face was exposed at a distance of 20cm from infrared lamp for minimum 5 - 10 minutes at a temperature of 30-40°C and a wavelength of 760-5000 nm. In general, the skin will not be burned during the induction process. Due to individual differences, if the subjects cannot tolerate or feel uncomfortable during the process, the investigators will stop the process according to the situation; If there is any burn during the process, the on-site dermatologist will treat it in time, and the subject needs to follow the dermatologist's advice for follow-up treatment. Infrared light type: PHILIPS, IR250 RH IR2, 230-250V, 250W, wave length 760-5000nm, T 30\~40°C

Group Blank; Group Serum

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.
• Regular users of cleanser, Serum, moisturizer and sunscreen product.
• Self-declare with skin concerns of redness and easy to flushing.
• 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\[2\] induction (5-10 mins) by dermatologist.
• No disagreement of dermatologist because of other reasons that exclude the participation 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 form.
• Must be willing to comply with all study protocol requirements (pay attention to: only use the provided product during the study, not take topical or oral treatment like retinol, hormone, anti-oxidant health-care products which may impact the efficacy of study).

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 Municipality, 200072, China

Location

MeSH Terms

Conditions

Erythema

Condition Hierarchy (Ancestors)

Skin Diseases; Skin and Connective Tissue Diseases; Skin Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Ping Xu

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

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 18, 2025
• First Posted: July 10, 2025
• Study Start: April 22, 2024
• Primary Completion: April 24, 2024
• Study Completion: May 17, 2024
• Last Updated: July 10, 2025

Record last verified: 2025-06

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)