Clinical Study of Trilinolein Cream for Prevention of Relapse in Remission of Moderate-to-severe Atopic Dermatitis.

Category Primary study
Registry of Trialsclinicaltrials.gov
Year 2024
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.
Epistemonikos ID: 99324637a56e1a99ba072d18d01eea3eb6bc7549
First added on: Jul 01, 2024