Clinical Study of BSZY Cream Intervention to Relieve Atopic Facial Dermatitis

Efficacy and Safety of BSZY Cream for Atopic Facial Dermatitis: a Randomized, Double-blind, Controlled Trial.

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.

Study Overview

• Status: Recruiting
• Conditions: Atopic Dermatitis of Face (Diagnosis)
• Intervention / Treatment: Other: BSZY Cream; Other: emulsion matrix

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.

• Study Type: Interventional
• Enrollment (Anticipated): 130
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Liang Hua; Phone Number: 021-65161782; Email: 18916017563@163.com

Study Locations

• China
  • Shanghai
    • Shanghai, Shanghai, China
      • Recruiting
      • Shanghai Yueyang Integrated Medicine Hospital
      • Contact: Jia Zhou; Phone Number: 021-65161782; Email: pdzhoujia@163.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

The general inclusion criteria for the study are as follows:

1. Meet the diagnostic criteria for patients with atopic dermatitis in the China Atopic Dermatitis Treatment Guidelines (2020 Edition);
2. Age ≥ 18 years old;
3. Able to cooperate with receiving topical cream treatment;
4. 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);
5. 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;
6. Facial manifestations of atopic dermatitis.

Exclusion Criteria:

1. Previous allergies to ingredients such as skin care products, soaps, alcohol, fragrances or medications;
2. Insulin-dependent diabetic patients;
3. Received anti-cancer chemotherapy within the last 6 months;
4. Patients with immune deficiencies or autoimmune diseases;
5. Lactating or pregnant women;
6. Bilateral mastectomy and bilateral axillary lymph node dissection;
7. Subjects with observed facial wounds, abrasions, tattoos, or other conditions affecting the determination of test results;
8. Have participated in outdoor, travel and other high-intensity sun exposure activities that may cause skin damage in the month prior to the test;
9. Those who are also participating in another clinical test or have participated in a facial clinical test within the last three months;
10. 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);
11. Clinical dermatologists or professionals believe there are other medical reasons that could affect the test results;
12. SCORAD score >50 (atopic dermatitis SCORAD score: mild: 0~24, moderate: 25~50, severe: >50).

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: BSZY Cream group; receiving BSZY Cream twice a day,in the morning and evening, for a period of four weeks.	Other: BSZY Cream; 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.
Placebo Comparator: emulsion matrix group; receiving the emulsion base twice a day, in the morning and evening, for a period of four weeks.	Other: emulsion matrix; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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.	At weeks 4 after the patient's admission

Secondary Outcome Measures

Outcome Measure	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
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

Collaborators and Investigators

• Sponsor: Shanghai Yueyang Integrated Medicine Hospital

Study record dates

Study Major Dates

• Study Start (Anticipated): April 1, 2023
• Primary Completion (Anticipated): June 30, 2024
• Study Completion (Anticipated): June 30, 2024

Study Registration Dates

• First Submitted: February 8, 2023
• First Submitted That Met QC Criteria: March 18, 2023
• First Posted (Actual): March 31, 2023

Study Record Updates

• Last Update Posted (Actual): March 31, 2023
• Last Update Submitted That Met QC Criteria: March 18, 2023
• Last Verified: March 1, 2023

More Information

Terms related to this study

• Keywords: atopic facial dermatitis.
• Additional Relevant MeSH Terms: Skin Diseases; Dermatitis
• Other Study ID Numbers: 2023-024

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No