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
Condition(s) studied
Investigational drug(s) / intervention(s)
LA ROCHE-POSAY CICAPLAST BALM, Standard cream: 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.
Study summary
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
Eligibility
Primary outcome measure(s)
- Sebum secretion on the skin surface — 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. - TEWL on the skin surface — 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. - Skin hydration on the skin surface — 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. - The pH value of the skin surface — 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. - Standardized facial image acquisition by VISIA — 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. - The safety and tolerability judgment by dermatologists based on the assessment of interviewed symptoms and observed signs — 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.
Trial sites (1)
| Facility | City | Region | Status |
|---|---|---|---|
| Shanghai China-norm Quality Technical Service Co., Ltd. | Shanghai | Shanghai Municipality | Recruiting |
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This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
View NCT07022288 on ClinicalTrials.gov ↗ ← All trials in China