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

ChinaNorm

Status: Enrolling

Conditions: Atopic Dermatitis of Face

Treatments: Other: LA ROCHE-POSAY CICAPLAST BALM, Standard cream

Study type: Interventional

Funder types: Industry

Identifiers

NCT07022288

C25005013

Details and patient eligibility

About

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

Enrollment: 76 estimated patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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76 participants in 2 patient groups

LA ROCHE-POSAY CICAPLAST BALM

Experimental group

Description:

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.

Treatment:

Other: LA ROCHE-POSAY CICAPLAST BALM, Standard cream

standard cream

Active Comparator group

Description:

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.

Treatment:

Other: LA ROCHE-POSAY CICAPLAST BALM, Standard cream