La Roche-Posay B5 Multi-Effect Soothing and Repairing Cream for Facial Atopic Dermatitis

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.

This will test whether La Roche-Posay's B5 Multi-Effect Soothing and Repairing Cream helps improve symptoms and objective skin measurements in adults with mild facial atopic dermatitis compared with a standard moisturizer over eight weeks.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 76 (estimated)
• Ages: 18 Years to 65 Years
• Sex: All
• Sponsor: ChinaNorm (Industry-sponsored)
• Locations: 1 site (Shanghai, Shanghai Municipality)
• Trial ID: NCT07022288 on ClinicalTrials.gov

What this trial studies

This randomized, interventional study will enroll 76 adults with mild facial atopic dermatitis and assign them to either the La Roche-Posay B5 cream or a control standard cream. Participants will be followed for eight weeks with four visits, and at least 60 completers are expected. Physiological skin indicators will be measured with objective instruments and compared between groups to judge repair and soothing effects, focusing on a formulation that includes skin microecological regulation components versus an ordinary moisturizer. The trial is conducted at a single site in Shanghai.

Who should consider this trial

Good fit: Adults aged 18 to 65 in generally good health with mild facial atopic dermatitis who have previously used topical or oral AD treatments and can attend four visits in Shanghai are ideal candidates.

Not a fit: Patients with moderate to severe atopic dermatitis, significant comorbid chronic illnesses, ages outside 18–65, or known sensitivity to the product ingredients are unlikely to benefit from this specific trial.

Why it matters

Potential benefit: If successful, the product could provide better soothing and barrier repair for mild facial atopic dermatitis than a standard moisturizer, reducing symptoms and improving skin measurements.

How similar studies have performed: Topical barrier-repair and moisturizing formulations have shown benefit in mild atopic dermatitis in prior research, so the approach has some precedent though this specific B5 formulation is being directly tested.

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.

Where this trial is running

Shanghai, Shanghai Municipality

• Shanghai China-norm Quality Technical Service Co., Ltd. — Shanghai, Shanghai Municipality, China (Recruiting)

Study contacts

• Principal investigator: Ping Xu, Master — Shanghai China-norm Quality Technical Service Co., Ltd.
• Study coordinator: Danwei Chen

Conditions Atopic Dermatitis of Face