Shanghai China-norm Quality Technical Service Co., Ltd.
Shanghai, Shanghai Municipality, 200072, China
NCT Number: NCT06985745
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.
This study is active but is not currently recruiting participants.
20 year–40 year
All sexes
Interventional
Not applicable
Shanghai, Shanghai Municipality, 200072, China
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
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
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).
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 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: 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 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.
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: Timepoint 2Week before baseline, Baseline,Time point immediate, Time point at 1Week , Time point at 4Week, Time point at 5Week, Time point at 6Week.
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: Baseline, Time point at 1Week , Time point at 4Week, Time point at 5Week, Time point at 6Week.
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 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 will be measured by Sebumeter® SM 815 by trained technician.
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.
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.
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 4Week.
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.
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: Time point immediate, Time point at 1Week , Time point at 4Week.
Consumer-reported outcomes will be assessed using a self-assessment questionnaire.
ChinaNorm
Industry
An Emulsion 2-Week Wash-out, 4-Week Application and Relapse for 2-Week Anti-acne Efficacy Clinical Study
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
Published trials that share one or more normalized conditions with this study.
NCT05748379
Dental Anxiety, Dental Implants
Riga, Latvija, Latvia
View Trial DetailsNCT06677528
Aortic Stenosis, Aortic Valve Disease
Bad Oeynhausen, Germany
View Trial DetailsNCT07715955
Adults, Body Weight
Maastricht, Limburg, Netherlands
View Trial DetailsNCT07692815
Female, Healthy Adult
Louvain-la-Neuve, Belgium
View Trial Details