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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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group Serum | Other |
| |
| Group Blank | Other |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Ping Xu | Shanghai China-norm Quality Technical Service Co., Ltd. | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Shanghai China-norm Quality Technical Service Co., Ltd. | Shanghai | Shanghai Municipality | 200072 | China |
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.
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.
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.
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| ID | Term |
|---|---|
| D004890 | Erythema |
| ID | Term |
|---|---|
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D012877 | Skin Manifestations |
| D012816 | Signs and Symptoms |
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| 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 |
|
| D013568 | Pathological Conditions, Signs and Symptoms |