Clinical Study of BSZY Cream Intervention to Relieve Atopic Facial Dermatitis

NCT ID: NCT05792826

Last Updated: 2023-03-31

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 130 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-04-01
• Study Completion Date: 2024-06-30

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.

Conditions

Atopic Dermatitis of Face (Diagnosis)

Keywords

atopic facial dermatitis.

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

BSZY Cream group

receiving BSZY Cream twice a day,in the morning and evening, for a period of four weeks.

Group Type: EXPERIMENTAL

BSZY Cream

Intervention Type: 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.

emulsion matrix group

receiving the emulsion base twice a day, in the morning and evening, for a period of four weeks.

Group Type: PLACEBO_COMPARATOR

emulsion matrix

Intervention Type: 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.

Interventions

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.

Intervention Type: 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.

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

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).

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Shanghai Yueyang Integrated Medicine Hospital

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Shanghai Yueyang Integrated Medicine Hospital

Shanghai, Shanghai Municipality, China

Site Status: RECRUITING

Countries

China

Central Contacts

Liang Hua

Role: CONTACT

Phone: 021-65161782

Email: 18916017563@163.com

Facility Contacts

Jia Zhou

Role: primary

References

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.

Reference Type: DERIVED

PMID: 40122554 (View on PubMed)

Other Identifiers

2023-024

Identifier Type: -

Identifier Source: org_study_id