Atopic Dermatitis Clinical Trial
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
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.
This randomized, double-blind, placebo-controlled trial will be conducted at 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, the First Affiliated Hospital of Naval Military Medical University, Yueyang Hospital of Traditional Chinese Medicine and Western Combined Hospital affiliated with Shanghai University of Traditional Chinese Medicine, the Seventh People's Hospital affiliated with Shanghai University of Traditional Chinese Medicine, Shanghai Jiading Hospital of Traditional Chinese Medicine, and the Combined Hospital of Traditional Chinese Medicine and Western Combined Hospital of Baoshan District of Shanghai. . The trial will start after ethical approval and protocol registration. Patient recruitment started in June 20234 and is expected to end in March 20257 . It is anticipated that 376 participants will be enrolled in the trial and randomly assigned in a 1:1 ratio to receive treatment with Trilinolein cream or cream base. The Standards for Reporting Interventions in Acupuncture Clinical Trials (STRICTA) and the SPIRIT Reporting Guidelines will be followed in the development of the standard protocol to clearly and transparently explain the relevant treatment processes. Potential subjects will be evaluated for eligibility to determine if inclusion and exclusion criteria are met. Eligible subjects will voluntarily provide written informed consent prior to randomization. The study will have a double-blind design.Trilinolein cream and cream base will be supplied by the manufacturer, registered, and then distributed by the designated investigator at the time of the visit. Unused cream will be collected and counted after each distribution except for the first distribution. ;
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