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65 male and female adult subjects will be enrolled in the study, recruited according to inclusion and non-inclusion criteria listed below, at least 60 subjects should complete questionnaire, at least 40 of them should complete clinical assessment, instrumental measurement and image capture. 20 of them should complete lipid sample collection, and at least 30 of them should complete the RCM captured.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group Emulsion | Other |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Standard Cleanser, Investigational emulsion, Standard moisturizer, Standard Sunscreen | Other | Products Application and Usage Instruction: Wash out: T-2W ~ T0 Frequency: AM: Standard cleanser + standard moisturizer + standard sunscreen PM: Standard cleanser + standard moisturizer Caution: All the products should be applied to full face. No any other skincare or facial make up products are used except provide products. b. Mode of application : 4-week Treatment T0 ~ T4W Frequency: AM: Standard cleanser + test emulsion (FLA#2039180 68) + standard sunscreen PM: Standard cleanser + test emulsion (FLA#2039180 68) Caution: All the products should be applied to full face. No other skincare or facial make up products are used except provide products. c. Mode of application : 2-week relapse T4W ~ T6W AM: Standard cleanser + standard moisturizer + standard sunscreen PM: Standard cleanser + standard moisturizer Usage Instruction: Test emulsion (FLA#2039180 68): Self-application 0.6 ml for full face by hand every day (2x/day). |
| Measure | Description | Time Frame |
|---|---|---|
| Clinical scoring for Counting of Acne | Clinical scoring for counting of acne lesions (inflammatory, non-inflammatory, and total), acne severity IGA, and post-inflammatory erythema (PIE) count will be performed by a dermatologist on the global face area. The IGA (Investigator's Global Assessment for acne severity) is rated on a 5-point scale (0 = clear, 4 = severe), as defined in the protocol. PIE is recorded as a numeric count of red marks. Acne lesions (papules, pustules, blackheads, whiteheads) are counted individually. | Timepoint 2Week before baseline,Baseline, Time point at 1Week , Time point at 4Week, Time point at 5Week, Time point at 6Week. |
| Clinical scoring for Redness around acne | Clinical scoring for redness around acne will be performed by a dermatologist using a visual scale from 0 to 9, where 0 = no redness and 9 = intense redness, as defined in the protocol. Half-point scores (e.g., 0.5) may be used. | Baseline,Time point immediate, Time point at 1Day, Time point at 3Day, Time point at 1Week , Time point at 4Week, Time point at 5Week, Time point at 6Week. |
| Clinical scoring for Diameter of tracking one Acne | The measurement of the diameter of one tracking inflammatory acne lesion will be performed by a dermatologist using a skin ruler. The maximum diameter in millimeters (mm) will be recorded at each time point. | Baseline,Time point immediate, Time point at 1Day, Time point at 3Day, Time point at 1Week. |
| Clinical scoring for Cheek Sebaceous Pores | Clinical scoring for cheek sebaceous pores (based on the Skin Aging Atlas, Asian type), as well as for redness, smoothness, radiance, brightness, and softness, will be performed by a dermatologist using a visual grading scale from 0 to 9, as defined in the protocol. Half-point scores (e.g., 0.5) may be used. | Timepoint 2Week before baseline, Baseline,Time point immediate, Time point at 1Week , Time point at 4Week, Time point at 5Week, Time point at 6Week. |
| Measure | Description | Time Frame |
|---|---|---|
| Consumer Questionnaire | Consumer-reported outcomes will be assessed using a self-assessment questionnaire. | Time point immediate, Time point at 1Week , Time point at 4Week. |
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Inclusion Criteria:
1) Skin smoothness (0-9 scale, 3≤ grade≤ 6) 2) Skin radiance (0-9 scale, 3≤ grade≤ 6) 3) Skin brightness (0-9 scale, 3≤ grade≤ 6) 4) Skin softness (0-9 scale, 3≤ grade≤ 6) 5) Skin redness (0-9 scale, 3≤ grade≤ 6) 9.No disagreement of dermatologist because of other reasons that exclude the participation of the subject.
10.In general good health at the time of the study. 11.Willing and able to participate as evidenced by signing of informed consent and photo release form.
12.Must be willing to comply with all study protocol requirements
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Ping Xu, Master | 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 |
|---|---|
| D000152 | Acne Vulgaris |
| ID | Term |
|---|---|
| D017486 | Acneiform Eruptions |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D012625 | Sebaceous Gland Diseases |
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| Skin hydration on the cheeks | Skin hydration on the cheeks will be measured by Corneometer® CM 825 by trained technician. | Baseline, Time point at 1Week , Time point at 4Week, Time point at 5Week, Time point at 6Week. |
| TEWL on the cheeks | TEWL on the cheeks will be measured by Vapometer by trained technician. | Baseline, Time point at 1Week , Time point at 4Week, Time point at 5Week, Time point at 6Week. |
| Sebum secretion on forehead | Sebum secretion on forehead will be measured by Sebumeter® SM 815 by trained technician. | Baseline, Time point at 1Week , Time point at 4Week, Time point at 5Week, Time point at 6Week. |
| Image capture and analysis(facial photo) | The facial photo will be captured by VISIA CRP (Canfield, Gen 5.0) on left, front and right sides with Standard 1, Cross-Polarized, Parallel-Polarized, UV operated by trained technician. -Demo for Pore area, skin reflection under Standard 1 and acne demo under Cross-Polarized. | Baseline, Time point immediate, Time point at 1Day, Time point at 3Day, Time point at 1Week , Time point at 4Week, Time point at 5Week, Time point at 6Week. |
| One tracking active acne image | One active inflammatory acne lesion will be imaged using Antera® 3D (Miravex). Image analysis will include acne volume (mm³) and area (mm²), using the Antera 3D CS software. | Baseline,Time point immediate, Time point at 1Day, Time point at 3Day, Time point at 1Week. |
| Image Capture and Analysis(RCM) | RCM (Reflectance Confocal Microscopy) will be captured on target acne -microcomedone ratio, size, hyper-keratin ratio will be analyzed. | Baseline, Time point 4Week. |
| Image Capture using VisioScan® VC20plus | Skin image will be captured using VisioScan® VC20plus (Courage + Khazaka) with Sebufix® F 16. Sebum production will be evaluated through sebum spot size and sebum distribution gradient using SELS software. | Baseline, Time point 4Week. |