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NCT Number: NCT07058701

Serum Instant Anti-Redness Efficacy Clinical Study

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.

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Key information

Conditions

Female Erythema Pathological Conditions, Signs and Symptoms Redness Signs and Symptoms Skin Diseases Skin Manifestations Skin and Connective Tissue Diseases

Age range

20 year–40 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

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

Shanghai, Shanghai Municipality, 200072, China

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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).

Exclusion criteria

  • 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.
  • Intake of antihistamines, antibiotics, corticosteroids, non-steroidal anti-inflammatories or immune-suppressants in the last 6 months before study

Treatment and study plan

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.

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

Primary outcomes

  1. Clinical scoring for skin redness

    Time frame: 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.

    Participants: N= 30

  2. Clinical scoring for skin redness

    Time frame: Baseline, Time point post-induction 5 min.

    Participants: N= 30

  3. Image Capture and Analysis（Redness area ratio）

    Time frame: 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.

    Participants: N= 30，by VISIA 7

  4. Image Capture and Analysis（Redness area ratio）

    Time frame: 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.

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

  5. Instrumental Assessment (Erythema index)

    Time frame: 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.

    Participants: N= 30, by Mexameter

  6. Consumer Questionnaire

    Time frame: 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.

    Participants: N= 60

Sponsors and collaborators

Lead sponsor

ChinaNorm

Industry

Registry information

Important dates

Study start
2024
Primary completion
2024
Study completion
2024
First posted
Jul 10, 2025
Registry last updated
Jul 10, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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