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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-65
SponsorChinaNorm

About this trial

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

This trial does not accept healthy volunteers

Qualifiers

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.;

Meeting Yao's diagnostic criteria,

Disqualifiers

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

Design model

Parallel

Treatments tested in this trial

  • LA ROCHE-POSAY CICAPLAST BALM, Standard cream

    Other intervention

    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.

Treatment groups

76 Participants
are divided into 2 treatment groups
Group A: LA ROCHE-POSAY CICAPLAST BALMExperimental treatment 1 intervention
Group B: standard creamActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

Sebum secretion on the skin surface

Sebum secretion on the skin surface will be measured by Sebumeter® SM 815 by trained technician.

Time frame
Baseline, Time point at 2Week, Time point at 4Week, Time point at 8Week.
2

TEWL on the skin surface

TEWL on the skin surface will be measured by Vapometer by trained technician.

Time frame
Baseline, Time point immediate,Time point at 2Week, Time point at 4Week, Time point at 8Week.
3

Skin hydration on the skin surface

Skin hydration on the skin surface will be measured by Corneometer® CM 825 by trained technician.

Time frame
Baseline, Time point immediate,Time point at 2Week, Time point at 4Week, Time point at 8Week.
4

The pH value of the skin surface

The pH value of the skin surface will be measured by Skin-pH Meter PH 905 by trained technician.

Time frame
Baseline, Time point immediate,Time point at 2Week, Time point at 4Week, Time point at 8Week.

Secondary outcomes

1

The diagnostic criteria for atopic dermatitis evaluated according to Yao's diagnostic criteria

Yao's diagnostic evaluation criteria scoring standards are as follows: 1. Itching; 2. Typical morphology and location (flexural dermatitis), or atypical morphology and location accompanied by dry skin; 3. Chronic or chronic relapsing course. The diagnosis of atopic dermatitis can be made if all three of the above criteria are met.

Time frame
Baseline, Time point immediate,Time point at 2Week, Time point at 4Week, Time point at 8Week.
2

The IGA (Investigator Global Assessment) scoring conducted by the investigator

The investigator performs the IGA (Investigator Global Assessment) scoring on the facial condition of study participants.(0 = clear,5 = very severe)

Time frame
Baseline,Time point at 2Week, Time point at 4Week, Time point at 8Week
3

The facial Eczema Area and Severity Index (F-EASI) scoring conducted by the investigator

The Facial Eczema Area and Severity Index (F-EASI) scores erythema (E), edema/induration/papulation (I), excoriation (EX), and lichenification (L) across the entire face, combined with the affected area.

Time frame
Baseline,Time point at 2Week, Time point at 4Week, Time point at 8Week
4

The clinical scoring for facial erythema

The clinical scoring for facial erythema (Erythema) is evaluated by dermatologists using a 0-4 grading scale(0 = none, 4 = severe).

Time frame
Baseline,Time point at 2Week, Time point at 4Week, Time point at 8Week

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.