This multicenter, randomized, double-blind, placebo-controlled will be conducted at Yueyang Hospital of Integrative Medicine, Shanghai University of Traditional Chinese Medicine; Seventh People's Hospital, Shanghai University of Traditional Chinese Medicine; Jiading District Hospital of Traditional Chinese Medicine, Shanghai; and Baoshan District Hospital of Integrative Medicine, Shanghai; Huashan Hospital affiliated with Fudan University, Longhua Hospital affiliated with Shanghai University of Traditional Chinese Medicine, Shuguang Hospital affiliated with Shanghai University of Traditional Chinese Medicine, and the First Affiliated Hospital of the Naval Medical University. Approximately 376 participants will be recruited and randomly assigned to the Trilinolein cream or cream base group using block group randomization. The primary outcome will be time to relapse (number of days from the start of dosing to the time of relapse rating), and secondary outcomes will include eczema area and severity indices, overall investigator ratings, visual itch analog scores, dermatologic quality of life indices, overall improvement rates, and safety metrics. All data from the study will be analyzed using the SPSS 23.0 statistical package.
Patients with a clear diagnosis of atopic dermatitis in accordance with the diagnostic criteria of Chinese and Western medicine;
Age ≥2 years and ≤75 years; gender is not limited;
Patients with a previous history of moderate to severe atopic dermatitis (EASI score ≥ 8, or SCORAD score ≥ 26, or IGA score ≥ 3);
Patients were in AD remission with a skin lesion IGA score ≤ 1 for 2 consecutive weeks;
Patients who are in the acute morbid stage and have erosion, exudation, and secondary infection;
Patients who are allergic to the test article and its components;
Patients who are currently participating in other clinical studies or have participated in other clinical studies within 1 month;
Patients with skin diseases other than AD in the area to be treated;
Parallel
trilinolein cream group
Other interventionApply trilinolein cream evenly to the affected skin twice daily. The dosage is calculated using Finger Tip Units (FTU) and should not exceed a maximum of 30 grams per day.
cream base group
Other interventionApply cream base evenly to the affected skin twice daily. The dosage is calculated using Finger Tip Units (FTU) and should not exceed a maximum of 30 grams per day.
Recurrence time
number of days from start of dosing to time of relapse assessment
Eczema Area and Severity Index(EASI)
One of the commonly used assessment indicators for atopic dermatitis
Investigator's Global Assessment(IGA)
One of the commonly used assessment indicators for atopic dermatitis
Visual Analogue Scale(VAS)
One of the commonly used assessment indicators for atopic dermatitis
Dermatology Life Quality Index(DLQI)
One of the commonly used assessment indicators for atopic dermatitis
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