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This randomized double-blind controlled trial will be conducted in conducted in the Department of Dermatology at the Yueyang Hospital of Integrated Traditional Chinese and Western Medicine in China.An estimated 130 participants will be recruited and randomly assigned to receive BSZY Cream or emulsion matrix group in a l:l ratio using SPSS 25.0 software.Application is twice a day, morning and evening, for four weeks.The primary outcome will be the SCORAD scale.The secondary outcomes included clinical dermatologist assessment forms, patient self-assessment questionnaires, and safety indicators.The adverse events will be recorded for safety evaluation. All data in the study will be analyzed using the SPSS 25.0 statistical software package.
This randomized, double-blind, controlled trial will be conducted at Yueyang Hospital of Integrated Traditional Chinese and Western Medicine affiliated to Shanghai University of Traditional Chinese Medicine. Trials will begin following ethics approval and protocol registration. Patient recruitment began in April 2023 and is expected to conclude in June 2024. An estimated 130 participants will be enrolled and randomized 1:1 to receive BSZY Cream or emulsion base. In the process of developing standard protocols, the Standards for Reporting Interventions in Clinical Trials of Acupuncture and Moxibustion (STRICTA) and the SPIRIT Reporting Guidelines will be followed to clearly and transparently explain the treatment process involved.
Potential subjects were assessed for eligibility for inclusion and exclusion criteria. Eligible participants will voluntarily provide written informed consent prior to randomization.
This study will use a double-blind design. Both BSZY Cream and emulsion base were provided by the manufacturer, and were distributed by designated research nurses after registration, once every 2 weeks. Except for the first dispensing, the unused lotion was collected and counted each time after dispensing.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| BSZY Cream group | Experimental | receiving BSZY Cream twice a day,in the morning and evening, for a period of four weeks. |
|
| emulsion matrix group | Placebo Comparator | receiving the emulsion base twice a day, in the morning and evening, for a period of four weeks. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| BSZY Cream | Other | The patients receive BSZY Cream twice a day, in the morning and evening, for a period of four weeks.The patients can continue using their usual sunscreen and cleansing products, and their skin care steps should follow their daily habits. It is not recommended to add or replace any previously unused skin care products during the testing period. |
| Measure | Description | Time Frame |
|---|---|---|
| SCORAD | The SCORAD score was calculated based on the types of lesions and body areas and was assessed separately for the head, neck, arms, legs, anterior trunk, back, and genitalia based on the area of skin involved and the severity of erythema, exudation, crusting, lichenification, and dryness. The scores report the severity of the patients' symptoms, with a total score ranging from 0 to 103, scores of 25 or lower indicating mild severity, scores of 26 to 50 indicating moderate severity, and scores of 51 to 103 indicating severe severity.. Patients were monitored for changes in SCROAD during treatment, observed for improvement in atopic dermatitis, and changes in points were calculated and compared before and after. | At weeks 0 after the patient's admission |
| SCORAD | The SCORAD score was calculated based on the types of lesions and body areas and was assessed separately for the head, neck, arms, legs, anterior trunk, back, and genitalia based on the area of skin involved and the severity of erythema, exudation, crusting, lichenification, and dryness. The scores report the severity of the patients' symptoms, with a total score ranging from 0 to 103, scores of 25 or lower indicating mild severity, scores of 26 to 50 indicating moderate severity, and scores of 51 to 103 indicating severe severity.. Patients were monitored for changes in SCROAD during treatment, observed for improvement in atopic dermatitis, and changes in points were calculated and compared before and after. | At weeks 2 after the patient's admission |
| SCORAD | The SCORAD score was calculated based on the types of lesions and body areas and was assessed separately for the head, neck, arms, legs, anterior trunk, back, and genitalia based on the area of skin involved and the severity of erythema, exudation, crusting, lichenification, and dryness. The scores report the severity of the patients' symptoms, with a total score ranging from 0 to 103, scores of 25 or lower indicating mild severity, scores of 26 to 50 indicating moderate severity, and scores of 51 to 103 indicating severe severity.. Patients were monitored for changes in SCROAD during treatment, observed for improvement in atopic dermatitis, and changes in points were calculated and compared before and after. |
| Measure | Description | Time Frame |
|---|---|---|
| Clinical Dermatologist Evaluation Form | At weeks 0, 2 and 4 after the patient's admission, the clinician assessed the skin condition of the patient's entire face on a scale of 0-4 for each of the four indicators: erythema, erythema, papules, edema and desquamation. | At weeks 0, 2 and 4 after the patient's admission |
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Inclusion Criteria:
The general inclusion criteria for the study are as follows:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Liang Hua | Contact | 021-65161782 | 18916017563@163.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Shanghai Yueyang Integrated Medicine Hospital | Recruiting | Shanghai | Shanghai Municipality | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 40122554 | Derived | Wang P, Wei X, Cheng L, Guo D, Du T, Guo W, Xi R, Duan Y, Liu X, Wang Y, Lu H, Yan G, Zhu J, Hua L, Li F. Efficacy and safety of BSZY cream for mild-to-moderate atopic facial dermatitis: protocol of a randomised, double-blind, controlled trial. BMJ Open. 2025 Mar 22;15(3):e087149. doi: 10.1136/bmjopen-2024-087149. |
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| ID | Term |
|---|---|
| D004194 | Disease |
| ID | Term |
|---|---|
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| emulsion matrix | Other | The patients receive emusion matrix twice a day, in the morning and evening, for a period of four weeks.The patients can continue using their usual sunscreen and cleansing products, and their skin care steps should follow their daily habits. It is not recommended to add or replace any previously unused skin care products during the testing period. |
|
| At weeks 4 after the patient's admission |
| Patient Self-Assessment Questionnaire |
Patients were asked to fill in the skin sensory self-assessment questionnaire at week 0, week 2 and week 4 after admission to the group to understand the improvement of their subjective symptoms. |
| At weeks 0, 2 and 4 after the patient's admission |
| Drug-Related Adverse Events. | The onset, duration, severity, management, and consequences of adverse events related to the study drug were recorded and their relationship to the use of the study drug was determined. | through study completion, an average of 1.5years |