Phase 4 Eczema Trial, Recruiting

Written by an AI model from ClinicalTrials.gov eligibility criteria and checked on a sample basis. Please confirm against the original criteria.

Who might be able to join this trial:

• Children and teenagers aged 6 to 17 years old at the time of joining the trial.
• People who have moderate to severe eczema (atopic dermatitis) that has not been well controlled with creams or ointments, and has been diagnosed by a skin or allergy specialist using a standard set of diagnostic criteria.
• People whose eczema has been rated as moderate or severe at the start of the trial using a standard assessment tool called the vIGA score.
• People (or their parent or guardian, for children under 8) who report significant sleep problems, based on a standard sleep questionnaire scoring 60 or above.
• People who are willing and able to attend all required visits and follow the study procedures.
• People who have been consistently using inhaled corticosteroids, topical steroids, or antihistamines for at least 14 days before joining the trial, without changes to those medications.

Who may not be able to join:

• People whose asthma is not well controlled, based on a standard test scoring 19 or below.
• People who report that hay fever (allergic rhinitis) has disturbed their sleep on 2 or more nights in the past week.
• People currently taking any medication known to cause scratching.
• People who have a serious medical condition such as cancer.
• People who have another condition that could affect sleep, such as sleep apnoea, restless legs syndrome, insomnia, narcolepsy, severe breathing problems during sleep, severe depression, COVID-19, or hives (urticaria).
• People who have applied topical steroid creams within 7 days before either of the sleep study (PSG) appointments.
• People who have used systemic immunosuppressant medications (medicines that reduce the immune system's activity taken by mouth or injection) within 30 days before the first sleep study appointment.
• People who have showered or used moisturisers within 12 hours before either sleep study appointment.
• People who are unable to communicate in English, as some of the questionnaires used in the study are not available in other languages.
• People for whom dupilumab (the medication being studied) would not be appropriate, such as those with a history of allergic reaction to dupilumab or any of its ingredients.
• People who are pregnant.
• People with clinical blindness, as this can affect the body's internal clock and sleep-wake cycle.

Important: Always verify eligibility with the trial site directly before applying.