Serum Instant Anti-Redness Efficacy Clinical Study

NCT ID: NCT07058701

Last Updated: 2025-07-10

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 65 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-04-22
• Study Completion Date: 2024-05-17

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: OTHER
• Blinding Strategy: TRIPLE

Study Groups

Group Serum

Group Type: OTHER

Investigational Serum, Standard Cleanser

Intervention Type: 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

Intervention Type: 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 Type: OTHER

Infrared Light for Redness Induction on Face

Intervention Type: 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

Interventions

Investigational Serum, Standard Cleanser

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.

Intervention Type: OTHER

Infrared Light for Redness Induction on Face

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

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

1. Chinese women aged from 20-40 years old.

2. Self-declared mild sensitive skin.

3. Regular users of cleanser, Serum, moisturizer and sunscreen product.

4. Self-declare with skin concerns of redness and easy to flushing.

5. Willing to be exposed to infrared light on the facial skin to induce facial redness (can tolerate heat sensation on the face).

6. Clinical grading of skin redness(visual) ≥ 4 after infrared light[2] induction (5-10 mins) by dermatologist.

7. No disagreement of dermatologist because of other reasons that exclude the participation of the subject.

8. In general good health at the time of the study.

9. Willing and able to participate as evidenced by signing of informed consent and photo release form.

10. 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

1. Allergic to infrared light

2. Pregnant or breast-feeding woman or woman planning pregnancy during the study.

3. Subject deprived of rights by a court or administrative order.

4. Major subject to a guardianship order.

5. Subject residing in a health or social care establishment.

6. Patient in an emergency setting.

7. Subject with a skin disease in the test areas (particularly e.g, acne, rosacea, eczema).

8. Subjects with history of atopy, allergic reactions, irritation or intense discomfort feelings to topical-use products, medication, cosmetic or personal care products or ingredients.

9. Subject presenting a stable or progressive serious disease (per investigator's assessment).

10. Immuno-compromised subject.

11. Subject presenting excessive exposure to sunlight or UV radiation (investigator's assessment).

12. Subjects regularly practicing aquatic or nautical sports.

13. Subjects regularly attending a sauna.

14. Subject with cardiovascular or circulatory history.

15. Subject with a history of skin cancer or malignant melanoma.

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

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 40 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

ChinaNorm

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Ping Xu

Role: PRINCIPAL_INVESTIGATOR

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

Locations

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

Shanghai, Shanghai Municipality, China

Countries

China

Other Identifiers

C24005025

Identifier Type: -

Identifier Source: org_study_id