FemaleNCT07058701
Serum Instant Anti-Redness Efficacy Clinical Study
A study testing Investigational Serum, Standard Cleanser and Infrared Light for Redness Induction on Face in people with Female and Redness, run by ChinaNorm at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 20 to 40 years, women onlyHealthy volunteers can take part
- What is being tested?
- Investigational Serum, Standard Cleanser and Infrared Light for Redness Induction on Face
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 65 participants
- Where
- 1 siteChina
- Study dates
- 22 Apr 2024to 17 May 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 40 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
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- 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).
Who cannot join
- 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.
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- 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
Trial locations and contacts
1 site in 1 country.
China1 site
Shanghai China-norm Quality Technical Service Co., Ltd.
Shanghai, Shanghai Municipality, 200072
About this 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.
- Being tested
- Investigational Serum, Standard Cleanser, Infrared Light for Redness Induction on Face
- Medical subject headings
- Erythema
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Investigational Serum, Standard CleanserOther
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 FaceDevice
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
| Study group | Role | What they receive |
|---|---|---|
| Group Serum | Other | Not described Receives: Other: Investigational Serum, Standard Cleanser; Device: Infrared Light for Redness Induction on Face |
| Group Blank | Other | Not described Receives: Device: Infrared Light for Redness Induction on Face |
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinical scoring for skin redness
Participants: N= 30
Measured: 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
Measured: Baseline, Time point post-induction 5 min.
Image Capture and Analysis（Redness area ratio）
Participants: N= 30，by VISIA 7
Measured: 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
Measured: 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
Measured: 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
Measured: 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.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jul 2025
- Study start22 Apr 2024
- Primary completion24 Apr 2024
- Study completion17 May 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for FemaleStudies of the same condition, open and under way.
- More trials run by ChinaNormThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Triple blind
- Who is masked
- Care provider, Investigator, Outcomes assessor
- Enrolment
- 65 participants (actual)
Sponsor and investigators
- Lead sponsor
- ChinaNorm
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Ping Xu, Principal investigator, Shanghai China-norm Quality Technical Service Co., Ltd.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07058701
- Sponsor's protocol ID
- C24005025
- Status last verified
- Jun 2025
- First submitted
- 18 Jun 2025
- Last updated
- 10 Jul 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: This Data Sharing Plan (DSP) aims to promote the open exchange and reuse of de-identified individual participant data (IPD) from cosmetic clinical research, including study protocols, case report forms (CRFs), and statistical analysis plans (SAPs). The shared data will be made available through compliant platforms to eligible researchers in dermatology, cosmetic science, and related fields, following ethical principles and data protection regulations. Users must sign a Data Use Agreement (DUA) to ensure data security, privacy protection, and compliance with research purposes.
Study at a glance
From the registry record, last updated by the sponsor on 10 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Serum Instant Anti-Redness Efficacy Clinical Study
- ClinicalTrials.gov ID
- NCT07058701
- Acronym / sponsor ID
- C24005025
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 65 participants (actual)
- Lead sponsor
- ChinaNormIndustry (pharma, biotech, devices)
- Study start
- 22 Apr 2024 (actual)
- Primary completion
- 24 Apr 2024 (actual)
- Study completion
- 17 May 2024 (actual)
- First posted
- 10 Jul 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Triple blind (care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- 20 to 40 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (10 listed)
- 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).
Key exclusion criteria (16 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Investigational Serum, Standard CleanserMode 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. | Other | Group Serum |
| Infrared Light for Redness Induction on FaceInfrared 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 | Device | Group Blank, Group Serum |
Primary outcome
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
Clinical scoring for skin redness
Time frame: Baseline, Time point post-induction 5 min.
Participants: N= 30
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
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
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
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Jul 2025.
- Individual participant dataSharing planned: Yes. This Data Sharing Plan (DSP) aims to promote the open exchange and reuse of de-identified individual participant data (IPD) from cosmetic clinical research, including study protocols, case report forms (CRFs), and statistical analysis plans (SAPs). The shared data will be made available through compliant platforms to eligible researchers in dermatology, cosmetic science, and related fields, following ethical principles and data protection regulations. Users must sign a Data Use Agreement (DUA) to ensure data security, privacy protection, and compliance with research purposes.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ping Xu principal investigator
Shanghai China-norm Quality Technical Service Co., Ltd.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Investigational Serum, Standard Cleanser and Infrared Light for Redness Induction on Face in people with Female and Redness, run by ChinaNorm at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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.). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Jul 2025.