Clinical trial NCT05792826: 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
Overall status: UNKNOWN
Phase: NA
Conditions: Atopic Dermatitis of Face (Diagnosis)
Keywords: atopic facial dermatitis.
Lead sponsor: Shanghai Yueyang Integrated Medicine Hospital
Sponsor class: OTHER
First posted: 2023-03-31
Enrollment: 130
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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).

Primary outcomes:
measure: SCORAD
timeFrame: At weeks 0 after the patient's admission
measure: SCORAD
timeFrame: At weeks 2 after the patient's admission
measure: SCORAD
timeFrame: At weeks 4 after the patient's admission
Secondary outcomes:
measure: Clinical Dermatologist Evaluation Form
timeFrame: At weeks 0, 2 and 4 after the patient's admission
measure: Patient Self-Assessment Questionnaire
timeFrame: At weeks 0, 2 and 4 after the patient's admission
measure: Drug-Related Adverse Events.
timeFrame: through study completion, an average of 1.5years
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Shanghai Yueyang Integrated Medicine Hospital
state: Shanghai
Study officials:
References: