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

Last updated: June 12, 2025
Sponsor: ChinaNorm
Overall Status: Active - Recruiting

Phase

N/A

Condition

Scalp Disorders

Skin Wounds

Allergies & Asthma

Treatment

LA ROCHE-POSAY CICAPLAST BALM, Standard cream

Clinical Study ID

NCT07022288
C25005013
  • Ages 18-65
  • All Genders

Study 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

Inclusion Criteria:

  1. Chinese males and females aged 18 to 65 years old (including 18 and 65 yearsold); 2) In good health, without any other chronic diseases or diseases undertreatment; 3) Have received atopic dermatitis drug treatments, including butnot 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% desonidecream/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, loratadinetablets, ebastine tablets, azelastine hydrochloride tablets, etc.;

  4. Other topical medications, such as zinc oxide oil (paste), black beandistillate oil ointment, topical phosphodiesterase 4 (PDE-4) inhibitorointment, physiological sodium chloride solution, and other wet dressingmedications, etc.; 4) At the baseline visit (Baseline), as determined by adermatologist:

  • 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 drugtreatment 5) At the baseline visit (Baseline), trans-epidermal water loss (TEWL) measurement value > 15g/m²/h 6) Voluntarily participate in thetrial, understand and be willing to sign the informed consent form; 7)Willing to follow the study protocol to use the products provided by thestudy throughout the study period, not use other similar products, keepdiaries, and attend regular follow-ups and other trial requirements.

Exclusion

Exclusion Criteria:

  1. Study participants who plan to become pregnant, are pregnant, arebreastfeeding, are within 6 months after childbirth, or are unwilling to takenecessary precautions to avoid pregnancy; 2) Study participants with atopicdermatitis in an acute exacerbation phase; 3) Study participants currentlyparticipating in other clinical trials or who have participated in otherclinical trials within the past 3 months; 4) Study participants who usedfunctional moisturizers containing skin microecology-regulating ingredientswithin 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), malignanttumors, poorly controlled chronic diseases, acute infectious diseases, majorsurgeries or trauma, psychological or mental disorders, or who require local orsystemic use of drugs/treatments affecting atopic dermatitis due to otherdiseases; 7) Study participants who experience explosive exacerbation of atopicdermatitis lesions after using the treatment regimen; 8) Study participantswith other skin diseases (acne, rosacea, eczema, infections, tumors, etc.) atthe study site or other skin conditions interfering with evaluation (birthmarks, scars, etc.); 9) Study participants with a habit of scratching orsqueezing atopic dermatitis lesions; 10) Study participants with a history ofallergy to the products and related ingredients provided in the study; 11)Study participants with poor compliance, known inability to attend visits ontime, or unwillingness to follow the study protocol during the study period;
  2. Other circumstances where the investigator deems it inappropriate for theparticipant to join the study.

Study Design

Total Participants: 76
Treatment Group(s): 1
Primary Treatment: LA ROCHE-POSAY CICAPLAST BALM, Standard cream
Phase:
Study Start date:
April 20, 2025
Estimated Completion Date:
October 31, 2025

Connect with a study center

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

    Shanghai, Shanghai 200072
    China

    Active - Recruiting

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