Clinical trial NCT07022288: 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
Official title: 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.
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Atopic Dermatitis of Face
Lead sponsor: ChinaNorm
Sponsor class: INDUSTRY
First posted: 2025-06-15
Enrollment: 76
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief 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 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.

Primary outcomes:
measure: Sebum secretion on the skin surface
timeFrame: Baseline, Time point at 2Week, Time point at 4Week, Time point at 8Week.
measure: TEWL on the skin surface
timeFrame: Baseline, Time point immediate,Time point at 2Week, Time point at 4Week, Time point at 8Week.
measure: Skin hydration on the skin surface
timeFrame: Baseline, Time point immediate,Time point at 2Week, Time point at 4Week, Time point at 8Week.
measure: The pH value of the skin surface
timeFrame: Baseline, Time point immediate,Time point at 2Week, Time point at 4Week, Time point at 8Week.
measure: Standardized facial image acquisition by VISIA
timeFrame: Baseline,Time point at 2Week, Time point at 4Week, Time point at 8Week.
measure: The safety and tolerability judgment by dermatologists based on the assessment of interviewed symptoms and observed signs
timeFrame: Baseline,Time point at 2Week, Time point at 4Week, Time point at 8Week.
Secondary outcomes:
measure: The diagnostic criteria for atopic dermatitis evaluated according to Yao's diagnostic criteria
timeFrame: Baseline, Time point immediate,Time point at 2Week, Time point at 4Week, Time point at 8Week.
measure: The IGA (Investigator Global Assessment) scoring conducted by the investigator
timeFrame: Baseline,Time point at 2Week, Time point at 4Week, Time point at 8Week
measure: The facial Eczema Area and Severity Index (F-EASI) scoring conducted by the investigator
timeFrame: Baseline,Time point at 2Week, Time point at 4Week, Time point at 8Week
measure: The clinical scoring for facial erythema
timeFrame: Baseline,Time point at 2Week, Time point at 4Week, Time point at 8Week
measure: Study participants perform visual analog scale (VAS) scoring
timeFrame: Baseline, Time point immediate,Time point at 2Week, Time point at 4Week, Time point at 8Week.
measure: The Dermatology Life Quality Index (DLQI) questionnaire completed by study participants
timeFrame: Baseline, Time point at 2Week, Time point at 4Week, Time point at 8Week.
measure: Skin microbiota detection
timeFrame: Baseline, Time point at 4Week , Time point at 8Week
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Shanghai China-norm Quality Technical Service Co., Ltd.
state: Shanghai
Study officials:
affiliation: Shanghai China-norm Quality Technical Service Co., Ltd.
name: Ping Xu, Master
role: PRINCIPAL_INVESTIGATOR
References: