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Clinical Study of Trilinolein Cream for Prevention of Relapse in Remission of Moderate-to-severe Atopic Dermatitis.
Sponsor: Shanghai Yueyang Integrated Medicine Hospital
Summary
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.
Official title: A Multicenter, Randomized, Double-blind, Controlled Clinical Study of Xia's Dermatology Method of Nourishing Blood and Moistening Dryness to Prevent Relapse in Remission of Moderate-to-severe Atopic Dermatitis
Key Details
Gender
All
Age Range
2 Years - 75 Years
Study Type
INTERVENTIONAL
Enrollment
376
Start Date
2024-06-15
Completion Date
2027-11-30
Last Updated
2024-06-17
Healthy Volunteers
No
Conditions
Interventions
trilinolein cream group
Apply 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
Apply 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.