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.

Overview

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

Interventions

• Other 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.

Primary outcome measures

• Sebum secretion on the skin surface [Time frame: Baseline, Time point at 2Week, Time point at 4Week, Time point at 8Week.]
• TEWL on the skin surface [Time frame: Baseline, Time point immediate,Time point at 2Week, Time point at 4Week, Time point at 8Week.]
• Skin hydration on the skin surface [Time frame: Baseline, Time point immediate,Time point at 2Week, Time point at 4Week, Time point at 8Week.]
• The pH value of the skin surface [Time frame: Baseline, Time point immediate,Time point at 2Week, Time point at 4Week, Time point at 8Week.]
• Standardized facial image acquisition by VISIA [Time frame: Baseline,Time point at 2Week, Time point at 4Week, Time point at 8Week.]
• The safety and tolerability judgment by dermatologists based on the assessment of interviewed symptoms and observed signs [Time frame: Baseline,Time point at 2Week, Time point at 4Week, Time point at 8Week.]

Secondary outcome measures (7)

• The diagnostic criteria for atopic dermatitis evaluated according to Yao's diagnostic criteria [Time frame: Baseline, Time point immediate,Time point at 2Week, Time point at 4Week, Time point at 8Week.]
• The IGA (Investigator Global Assessment) scoring conducted by the investigator [Time frame: Baseline,Time point at 2Week, Time point at 4Week, Time point at 8Week]
• The facial Eczema Area and Severity Index (F-EASI) scoring conducted by the investigator [Time frame: Baseline,Time point at 2Week, Time point at 4Week, Time point at 8Week]
• The clinical scoring for facial erythema [Time frame: Baseline,Time point at 2Week, Time point at 4Week, Time point at 8Week]
• Study participants perform visual analog scale (VAS) scoring [Time frame: Baseline, Time point immediate,Time point at 2Week, Time point at 4Week, Time point at 8Week.]
• The Dermatology Life Quality Index (DLQI) questionnaire completed by study participants [Time frame: Baseline, Time point at 2Week, Time point at 4Week, Time point at 8Week.]
• Skin microbiota detection [Time frame: Baseline, Time point at 4Week , Time point at 8Week]

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:

• 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.;
• Topical calcineurin inhibitors (TCI), such as 1% pimecrolimus cream, 0.03%/0.1% tacrolimus ointment, etc.;
• Oral antihistamines, such as cetirizine hydrochloride tablets, loratadine tablets, ebastine tablets, azelastine hydrochloride tablets, etc.;
• 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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Open label

Primary purpose

Supportive care

Study locations

China · 1 center

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

Identifiers

NCT: NCT07022288 · C25005013

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗