Recruiting

B5 Cream for Facial Atopic Dermatitis

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What is being tested

LA ROCHE-POSAY CICAPLAST BALM, Standard cream

Other
Who is being recruted

From 18 to 65 Years
See all eligibility criteria
How is the trial designed

Supportive Care Study

Interventional
Study Start: April 2025
See protocol details

Summary

Principal SponsorChinaNorm
Study ContactDanwei Chen
Last updated: January 28, 2026
Sourced from a government-validated database.Claim as a partner

Study start date: April 20, 2025

Actual date on which the first participant was enrolled.

The study is designed to test a new cream called La Roche-Posay's B5 Multi-Effect Soothing and Repairing Cream on individuals with mild facial atopic dermatitis. Atopic dermatitis is a condition that makes the skin red and itchy. The study will compare the new cream's effectiveness against regular moisturizers without special ingredients that help balance skin bacteria. By checking how well the cream repairs and soothes the skin, the study aims to find better ways to manage this uncomfortable skin condition, potentially improving the lives of those affected. Participants in the study will be involved for an 8-week period and will need to visit the research center four times. They will be randomly assigned to use either the experimental cream or a standard moisturizer. The effectiveness of the creams will be measured using special instruments that objectively assess skin condition. This way, researchers can see if the new cream provides better relief and repair for those with atopic dermatitis. While the study does not mention specific risks, the main focus is on the potential skin improvement benefits from using the new cream.

Official TitleA Clinical Study Evaluating the Application of La Roche-Posay's New B5 Multi-Effect Soothing and Repairing Cream on Individuals With Facial Atopic Dermatitis.
NCT07022288
Principal SponsorChinaNorm
Study ContactDanwei Chen
Last updated: January 28, 2026
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

76 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Supportive Care Study

These studies explore ways to improve comfort and daily life for people living with a condition. They may focus on easing symptoms, reducing treatment side effects, or supporting overall well-being.



Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

From 18 to 65 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Criteria

Inclusion Criteria: * 1\) Chinese males and females aged 18 to 65 years old (including 18 and 65 years old); 2) In good health, without any other chronic diseases or diseases under treatment; 3) Have received atopic dermatitis drug treatments, including but not limited to: 1. Topical glucocorticoids (TSC), such as 0.05% fluticasone propionate cream, 0.1% mometasone furoate cream, 0.1% hydrocortisone butyrate cream, 0.1% triamcinolone acetonide cream, 0.25% hydrocortisone cream, 0.05% desonide cream/ointment, etc.; 2. Topical calcineurin inhibitors (TCI), such as 1% pimecrolimus cream, 0.03%/0.1% tacrolimus ointment, etc.; 3. Oral antihistamines, such as cetirizine hydrochloride tablets, loratadine tablets, ebastine tablets, azelastine hydrochloride tablets, etc.; 4. Other topical medications, such as zinc oxide oil (paste), black bean distillate oil ointment, topical phosphodiesterase 4 (PDE-4) inhibitor ointment, physiological sodium chloride solution, and other wet dressing medications, etc.; 4) At the baseline visit (Baseline), as determined by a dermatologist: * Meeting Yao's diagnostic criteria, * Atopic dermatitis severity is mild (Investigator Global Assessment, IGA ≤ 2 points); * The condition is in a stable phase and no longer requires topical drug treatment 5) At the baseline visit (Baseline), trans-epidermal water loss (TEWL) measurement value \> 15g/m²/h 6) Voluntarily participate in the trial, understand and be willing to sign the informed consent form; 7) Willing to follow the study protocol to use the products provided by the study throughout the study period, not use other similar products, keep diaries, and attend regular follow-ups and other trial requirements. Exclusion Criteria: * 1\) Study participants who plan to become pregnant, are pregnant, are breastfeeding, are within 6 months after childbirth, or are unwilling to take necessary precautions to avoid pregnancy; 2) Study participants with atopic dermatitis in an acute exacerbation phase; 3) Study participants currently participating in other clinical trials or who have participated in other clinical trials within the past 3 months; 4) Study participants who used functional moisturizers containing skin microecology-regulating ingredients within 1 week before enrollment; 5) Study participants who received physical, chemical, or cosmetic surgical treatments within 3 months before enrollment; 6) Study participants with systemic diseases (severe organ damage), malignant tumors, poorly controlled chronic diseases, acute infectious diseases, major surgeries or trauma, psychological or mental disorders, or who require local or systemic use of drugs/treatments affecting atopic dermatitis due to other diseases; 7) Study participants who experience explosive exacerbation of atopic dermatitis lesions after using the treatment regimen; 8) Study participants with other skin diseases (acne, rosacea, eczema, infections, tumors, etc.) at the study site or other skin conditions interfering with evaluation (birthmarks, scars, etc.); 9) Study participants with a habit of scratching or squeezing atopic dermatitis lesions; 10) Study participants with a history of allergy to the products and related ingredients provided in the study; 11) Study participants with poor compliance, known inability to attend visits on time, or unwillingness to follow the study protocol during the study period; 12) Other circumstances where the investigator deems it inappropriate for the participant to join the study.

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives

2 intervention groups are designated in this study

This study does not include a placebo group 

Treatment Groups

Group I

Experimental
Products Application and Usage Instruction Mode of application: 0 Day\~8 weeks Frequency: the study participants should apply LA ROCHE-POSAY CICAPLAST BALM to the entire face twice daily (morning and evening), with each application ranging from 0.5 to 0.75 grams.

Group II

Active Comparator
Products Application and Usage Instruction Mode of application: 0 Day\~8 weeks Frequency: the study participants should apply standard cream to the entire face twice daily (morning and evening), with each application ranging from 0.5 to 0.75 grams.

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 1 location

Recruiting

Shanghai China-norm Quality Technical Service Co., Ltd.

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Recruiting
One Study Center