A Clinical Study Evaluating the Application of La Roche-P... | NCT07022288

Status Module

Description Module

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
LA ROCHE-POSAY CICAPLAST BALM	Experimental	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.	Other: LA ROCHE-POSAY CICAPLAST BALM, Standard cream
standard cream	Active Comparator	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.	Other: LA ROCHE-POSAY CICAPLAST BALM, Standard cream

Interventions

Name	Type	Description	Arm Group Labels	Other Names
LA ROCHE-POSAY CICAPLAST BALM, Standard cream	Other	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.

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Sebum secretion on the skin surface	Sebum secretion on the skin surface will be measured by Sebumeter® SM 815 by trained technician.	Baseline, Time point at 2Week, Time point at 4Week, Time point at 8Week.
TEWL on the skin surface	TEWL on the skin surface will be measured by Vapometer by trained technician.	Baseline, Time point immediate,Time point at 2Week, Time point at 4Week, Time point at 8Week.
Skin hydration on the skin surface	Skin hydration on the skin surface will be measured by Corneometer® CM 825 by trained technician.	Baseline, Time point immediate,Time point at 2Week, Time point at 4Week, Time point at 8Week.
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.	Baseline, Time point immediate,Time point at 2Week, Time point at 4Week, Time point at 8Week.
Standardized facial image acquisition by VISIA	Trained professionals will use the standard light source and polarized light source in Visia 7 to photograph the frontal, left, and right sides of the study participants' faces for facial image acquisition.	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	During the study, dermatologists will assess the facial condition of study participants. At each visit, each participant will be asked: "Are you experiencing any discomfort now?" If the participant answers "yes", the specific type of discomfort (e.g., tightness, stinging, burning, itching, or any other discomfort) should be recorded, along with the intensity and location of the discomfort. Additionally, dermatologists must carefully document the exact location (e.g., left cheek, right cheek, periocular area, etc.) of observed signs (such as erythema, edema, dryness, desquamation, acne, or any other symptoms) during the examination.

Secondary Outcomes

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

Eligibility Module

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.