Shanghai China-norm Quality Technical Service Co., Ltd.
Shanghai, Shanghai Municipality, 200072, China
Location status: Recruiting
NCT Number: NCT07022288
This study plans to recruit 76 subjects in accordance with the above inclusion and exclusion criteria, with at least 60 subjects completing the study. The study period is 8 weeks, and the subjects need to visit the research center 4 times. After the subjects are enrolled, they will be randomly divided into two groups, including the experimental product group and the control product group.
The physiological indicators of the skin were measured by objective instruments and compared with those of ordinary moisturizers without skin microecological regulation components to evaluate the repair promotion effect and improvement of La Roche-Posay's new B5 Multi-Effect Soothing and Repairing Cream on the affected areas of patients with mild atopic dermatitis on the
Interested in participating?
Request Info18 year–65 year
All sexes
Interventional
Not applicable
Shanghai, Shanghai Municipality, 200072, China
Location status: Recruiting
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
After enrollment, the investigator will generate random serial numbers for grouping through simple randomization.
LA ROCHE-POSAY CICAPLAST BALM:8 weeks application It is a leave-on product. It should be applied to the face twice a day during the research period.
Standard cream:8 weeks application It is a leave-on product. It should be applied to the face twice a day during the research period.
Time frame: Baseline, Time point at 2Week, Time point at 4Week, Time point at 8Week.
Sebum secretion on the skin surface will be measured by Sebumeter® SM 815 by trained technician.
Time frame: Baseline, Time point immediate,Time point at 2Week, Time point at 4Week, Time point at 8Week.
TEWL on the skin surface will be measured by Vapometer by trained technician.
Time frame: Baseline, Time point immediate,Time point at 2Week, Time point at 4Week, Time point at 8Week.
Skin hydration on the skin surface will be measured by Corneometer® CM 825 by trained technician.
Time frame: Baseline, Time point immediate,Time point at 2Week, Time point at 4Week, Time point at 8Week.
The pH value of the skin surface will be measured by Skin-pH Meter PH 905 by trained technician.
Time frame: Baseline,Time point at 2Week, Time point at 4Week, Time point at 8Week.
Trained professionals will use the standard light source and polarized light source in Visia 7 to photograph the frontal, left, and right sides of the study participants' faces for facial image acquisition.
Time frame: Baseline,Time point at 2Week, Time point at 4Week, Time point at 8Week.
During the study, dermatologists will assess the facial condition of study participants. At each visit, each participant will be asked: "Are you experiencing any discomfort now?" If the participant answers "yes", the specific type of discomfort (e.g., tightness, stinging, burning, itching, or any other discomfort) should be recorded, along with the intensity and location of the discomfort. Additionally, dermatologists must carefully document the exact location (e.g., left cheek, right cheek, periocular area, etc.) of observed signs (such as erythema, edema, dryness, desquamation, acne, or any other symptoms) during the examination.
Time frame: Baseline, Time point immediate,Time point at 2Week, Time point at 4Week, Time point at 8Week.
Yao's diagnostic evaluation criteria scoring standards are as follows:
The diagnosis of atopic dermatitis can be made if all three of the above criteria are met.
Time frame: Baseline,Time point at 2Week, Time point at 4Week, Time point at 8Week
The investigator performs the IGA (Investigator Global Assessment) scoring on the facial condition of study participants.(0 = clear,5 = very severe)
Time frame: Baseline,Time point at 2Week, Time point at 4Week, Time point at 8Week
The Facial Eczema Area and Severity Index (F-EASI) scores erythema (E), edema/induration/papulation (I), excoriation (EX), and lichenification (L) across the entire face, combined with the affected area.
Time frame: Baseline,Time point at 2Week, Time point at 4Week, Time point at 8Week
The clinical scoring for facial erythema (Erythema) is evaluated by dermatologists using a 0-4 grading scale(0 = none, 4 = severe).
Time frame: Baseline, Time point immediate,Time point at 2Week, Time point at 4Week, Time point at 8Week.
Study participants perform visual analog scale (VAS) scoring for facial Itch, skin tightness, burning, stinging, and pain.
The Visual Analog Scale (VAS) is a straight line with extreme values of facial discomfort at both ends. The leftmost end of the scale is "no discomfort" (score = 0 mm), and the rightmost end is "extreme discomfort" (the most severe degree imaginable) (score = 100 mm).
Time frame: Baseline, Time point at 2Week, Time point at 4Week, Time point at 8Week.
Study participants fill in the Dermatology Life Quality Index (DLQI) questionnaire based on their actual quality of life.Use a 0-3 scoring scale (0 = none, 3 = very severe).
Time frame: Baseline, Time point at 4Week , Time point at 8Week
Trained operators will sample the marked typical affected areas of atopic dermatitis in study participants for biological sample collection. Microbial samples will be collected using swabs.
Alpha/beta diversity:Based on next-generation sequencing (NGS) technology, 16S rRNA sequencing will be used to detect changes in skin bacterial species of interest from baseline to time point at 8week, including variations in species richness and diversity (alpha/beta diversity).
Contact information is provided by the study sponsor or research team.
ChinaNorm
Industry
A Clinical Study Evaluating the Application of La Roche-Posay's New B5 Multi-Effect Soothing and Repairing Cream on Individuals With Facial Atopic Dermatitis.
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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.