An interventional study of Standard Cleanser, Investigational emulsion, Standard moisturizer, Standard Sunscreen in Female, Male and Acne, sponsored by ChinaNorm. Active, not recruiting at 1 site in China. Open to participants aged 20 Years to 40 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-05-30.
Sponsored by ChinaNorm · Not applicable, Interventional, and Other
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.
729 studies on the registry are indexed under Acne Vulgaris; 85 are open to participants now.
This study's enrollment of 66 is close to the median of 68 across 627 interventional studies indexed under Acne Vulgaris.
Browse Acne Vulgaris studies →ChinaNorm is the lead sponsor of 24 studies on the registry; 11 are open to participants now.
Counted across the registry records on this site, refreshed daily.
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:
Other: Standard Cleanser, Investigational emulsion, Standard moisturizer, Standard Sunscreen
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).
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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: Timepoint 2Week before baseline, Baseline，Time point immediate, Time point at 1Week , Time point at 4Week, Time point at 5Week, Time point at 6Week.
Skin hydration on the cheeks
Skin hydration on the cheeks will be measured by Corneometer® CM 825 by trained technician.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: Baseline, Time point 4Week.
Consumer Questionnaire
Consumer-reported outcomes will be assessed using a self-assessment questionnaire.
Time frame: Time point immediate, Time point at 1Week , Time point at 4Week.
Plan to share: 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.
Supporting information: Study protocol, Sap, Icf, Csr, Analytic code
No publications or documents are linked to this record.
This study is active, not recruiting, as verified in May 2025. You cannot join it, but the record below documents what was studied.
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