Description Module
The Description Module contains narrative descriptions of the clinical trial, including a brief summary and detailed description. These descriptions provide important information about the study's purpose, methodology, and key details in language accessible to both researchers and the general public.
Description Module path is as follows:
Study -> Protocol Section -> Description Module
Description Module
Ignite Creation Date:
2025-12-24 @ 9:45 PM
Ignite Modification Date:
2025-12-24 @ 9:45 PM
NCT ID:
NCT06366932
Brief Summary:
This is a low-intervention phase IV trial. The main objective is to optimize the treatment of patients with moderate-severe atopic dermatitis that require systemic treatment after failure, intolerance or contraindication to cyclosporine.
Detailed Description:
Primary outcome is the percentage of patients with primary non-response to second-line treatment. Defined as fail to achieve EASI-75 (a 75% improvement in EASI score) at week 16 of follow-up. A 12-month recruitment period is planned and about 150 patients with moderate-severe atopic dermatitis will be recruited. The study is divided into two cohorts. All patients diagnosed with moderate to severe atopic dermatitis who are going to receive second-line systemic treatment at the Dermatology Department of La Paz University Hospital are selected in cohort 1. Patients will receive the starting dose used in routine clinical practice. All patients diagnosed with moderate to severe atopic dermatitis who are receiving second-line systemic treatment at the Dermatology Department of La Paz University Hospital will be selected in cohort 2.
Study:
NCT06366932
Study Brief:
Protocol Section:
NCT06366932