Back to resultsClinical Study of BSZY Cream Intervention to Relieve Atopic Facial Dermatitis
Primary Purpose
Atopic Dermatitis of Face (Diagnosis)
Status
Recruiting
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
BSZY Cream
emulsion matrix
Sponsored by
About this trial
This is an interventional treatment trial for Atopic Dermatitis of Face (Diagnosis) focused on measuring atopic facial dermatitis.
Eligibility Criteria
Inclusion Criteria: The general inclusion criteria for the study are as follows: Meet the diagnostic criteria for patients with atopic dermatitis in the China Atopic Dermatitis Treatment Guidelines (2020 Edition); Age ≥ 18 years old; Able to cooperate with receiving topical cream treatment; Voluntary participation in clinical trial studies and signing of informed consent (informed consent signed by the patient, legal guardian or person in charge of the medical situation via paper signature); Willingness to replace the test product with a cream-based product currently in use. Not be recommended to use their own skin care products in that dosage form throughout the testing period; Facial manifestations of atopic dermatitis. Exclusion Criteria: Previous allergies to ingredients such as skin care products, soaps, alcohol, fragrances or medications; Insulin-dependent diabetic patients; Received anti-cancer chemotherapy within the last 6 months; Patients with immune deficiencies or autoimmune diseases; Lactating or pregnant women; Bilateral mastectomy and bilateral axillary lymph node dissection; Subjects with observed facial wounds, abrasions, tattoos, or other conditions affecting the determination of test results; Have participated in outdoor, travel and other high-intensity sun exposure activities that may cause skin damage in the month prior to the test; Those who are also participating in another clinical test or have participated in a facial clinical test within the last three months; Vitamin A, a hydroxy acid, salicylic acid, hydroquinone applied within the last 3 months, or prescription drugs (antibiotics, vitamin A, a hydroxy acid and steroids) within the last 6 months, oral contraceptives (if you have been taking the same type of contraceptive for the last 6 months, you can continue to take them); Clinical dermatologists or professionals believe there are other medical reasons that could affect the test results; SCORAD score >50 (atopic dermatitis SCORAD score: mild: 0~24, moderate: 25~50, severe: >50).
Sites / Locations
- Shanghai Yueyang Integrated Medicine HospitalRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
BSZY Cream group
emulsion matrix group
Arm Description
receiving BSZY Cream twice a day,in the morning and evening, for a period of four weeks.
receiving the emulsion base twice a day, in the morning and evening, for a period of four weeks.
Outcomes
Primary Outcome Measures
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.
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.
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.
Secondary Outcome Measures
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.
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.
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.
Full Information
NCT ID
NCT05792826
First Posted
February 8, 2023
Last Updated
March 18, 2023
Sponsor
Shanghai Yueyang Integrated Medicine Hospital
1. Study Identification
Unique Protocol Identification Number
NCT05792826
Brief Title
Clinical Study of BSZY Cream Intervention to Relieve Atopic Facial Dermatitis
Official Title
Efficacy and Safety of BSZY Cream for Atopic Facial Dermatitis: a Randomized, Double-blind, Controlled Trial.
Study Type
Interventional
2. Study Status
Record Verification Date
March 2023
Overall Recruitment Status
Recruiting
Study Start Date
April 1, 2023 (Anticipated)
Primary Completion Date
June 30, 2024 (Anticipated)
Study Completion Date
June 30, 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Shanghai Yueyang Integrated Medicine Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
Brief Summary
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.
Detailed Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Atopic Dermatitis of Face (Diagnosis)
Keywords
atopic facial dermatitis.
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
130 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
BSZY Cream group
Arm Type
Experimental
Arm Description
receiving BSZY Cream twice a day,in the morning and evening, for a period of four weeks.
Arm Title
emulsion matrix group
Arm Type
Placebo Comparator
Arm Description
receiving the emulsion base twice a day, in the morning and evening, for a period of four weeks.
Intervention Type
Other
Intervention Name(s)
BSZY Cream
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
emulsion matrix
Intervention Description
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.
Primary Outcome Measure Information:
Title
SCORAD
Description
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.
Time Frame
At weeks 0 after the patient's admission
Title
SCORAD
Description
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.
Time Frame
At weeks 2 after the patient's admission
Title
SCORAD
Description
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.
Time Frame
At weeks 4 after the patient's admission
Secondary Outcome Measure Information:
Title
Clinical Dermatologist Evaluation Form
Description
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.
Time Frame
At weeks 0, 2 and 4 after the patient's admission
Title
Patient Self-Assessment Questionnaire
Description
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.
Time Frame
At weeks 0, 2 and 4 after the patient's admission
Title
Drug-Related Adverse Events.
Description
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.
Time Frame
through study completion, an average of 1.5years
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
The general inclusion criteria for the study are as follows:
Meet the diagnostic criteria for patients with atopic dermatitis in the China Atopic Dermatitis Treatment Guidelines (2020 Edition);
Age ≥ 18 years old;
Able to cooperate with receiving topical cream treatment;
Voluntary participation in clinical trial studies and signing of informed consent (informed consent signed by the patient, legal guardian or person in charge of the medical situation via paper signature);
Willingness to replace the test product with a cream-based product currently in use. Not be recommended to use their own skin care products in that dosage form throughout the testing period;
Facial manifestations of atopic dermatitis.
Exclusion Criteria:
Previous allergies to ingredients such as skin care products, soaps, alcohol, fragrances or medications;
Insulin-dependent diabetic patients;
Received anti-cancer chemotherapy within the last 6 months;
Patients with immune deficiencies or autoimmune diseases;
Lactating or pregnant women;
Bilateral mastectomy and bilateral axillary lymph node dissection;
Subjects with observed facial wounds, abrasions, tattoos, or other conditions affecting the determination of test results;
Have participated in outdoor, travel and other high-intensity sun exposure activities that may cause skin damage in the month prior to the test;
Those who are also participating in another clinical test or have participated in a facial clinical test within the last three months;
Vitamin A, a hydroxy acid, salicylic acid, hydroquinone applied within the last 3 months, or prescription drugs (antibiotics, vitamin A, a hydroxy acid and steroids) within the last 6 months, oral contraceptives (if you have been taking the same type of contraceptive for the last 6 months, you can continue to take them);
Clinical dermatologists or professionals believe there are other medical reasons that could affect the test results;
SCORAD score >50 (atopic dermatitis SCORAD score: mild: 0~24, moderate: 25~50, severe: >50).
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Liang Hua
Phone
021-65161782
Email
18916017563@163.com
Facility Information:
Facility Name
Shanghai Yueyang Integrated Medicine Hospital
City
Shanghai
State/Province
Shanghai
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jia Zhou
Phone
021-65161782
Email
pdzhoujia@163.com
12. IPD Sharing Statement
Plan to Share IPD
Yes
Learn more about this trial
Clinical Study of BSZY Cream Intervention to Relieve Atopic Facial Dermatitis
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