Optimization of Cyclosporin in Atopic Dermatitis Through Multiomic Predictive Models of Treatment Response

• Status: Recruiting
• Trial end date: 2024-07-01
• Target enrollment: 0
• Participant gender: All

Summary

This is a low-intervention phase IV trial. The main objective is to optimize the treatment of patients with moderate-severe atopic dermatitis who require systemic treatment.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Instituto de Investigación Hospital Universitario La Paz
• Treatments: Cyclosporine; Cyclosporins

Criteria

Inclusion Criteria:

Cohort 1:

1. Subjects diagnosed with moderate-severe atopic dermatitis who are going to receive treatment with cyclosporine.

2. Participants must be willing and able to provide written informed consent prior the initiation of any study procedures.

3. For children, parent/legal guardian must provide written informed consent. If age >11 years old, the minor must give assent.

4. Participant is willing and able to adhere to the procedures specified in this protocol.

Cohort 2:

1. Subjects diagnosed with moderate-severe atopic dermatitis who are receiving or have received in the past treatment with cyclosporine.

2. Participants must be willing and able to provide written informed consent prior the initiation of any study procedures.

3. For children, parent/legal guardian must provide written informed consent. If age >11 years old, the minor must give assent.

4. Participant is willing and able to adhere to the procedures specified in this protocol.

Exclusion Criteria:

1. Subjects participating in a clinical trial in the last three months.

2. Any condition or situation precluding or interfering the compliance with the protocol.

3. Women of childbearing potential must have a negative urine pregnancy test at Screening and Day 0.

4. Women of childbearing potential must commit not to become pregnant. They must be willing to use highly effective contraceptive methods or have practiced sexual abstinence during the study. Highly effective contraceptive methods include oral, intravaginal, or transdermal combined (oestrogen and progestogen containing) hormonal contraception associated with inhibition of ovulation; oral, injectable, or implantable progestogen-only hormonal contraception associated with inhibition of ovulation; intrauterine device; intrauterine hormone-releasing system; bilateral tubal occlusion; vasectomised partner and sexual abstinence.