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

Launched by CHINANORM · Jun 12, 2025

Keywords

ClinConnect Summary

This clinical trial is investigating the effectiveness of a new cream called La Roche-Posay's B5 Multi-Effect Soothing and Repairing Cream for people with mild facial atopic dermatitis, a common skin condition that causes itching and redness. The study will include 76 participants who are between 18 and 65 years old and in good health, without other chronic diseases. To qualify, participants must have previously used treatments for atopic dermatitis and have mild symptoms as determined by a dermatologist.

Over an 8-week period, participants will be divided into two groups: one will use the new cream, while the other will use a standard moisturizer without special ingredients. They will visit the research center four times during the study to track their skin's condition. This trial will help understand how well the new cream works compared to regular moisturizers in improving the symptoms of atopic dermatitis. It's important for participants to commit to using only the study products and to attend all required visits.

Gender

ALL

Eligibility 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.