Last updated: April 27, 2023
Sponsor: Instituto de Investigación Hospital Universitario La Paz
Overall Status: Active - Recruiting
Phase
4
Condition
Atopic Dermatitis
Rash
Allergy
Treatment
N/AClinical Study ID
NCT05692843
2022-500677-14-00
All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria: Cohort 1:
- Subjects diagnosed with moderate-severe atopic dermatitis who are going to receivetreatment with cyclosporine.
- Participants must be willing and able to provide written informed consent prior theinitiation of any study procedures.
- For children, parent/legal guardian must provide written informed consent. If age >11years old, the minor must give assent.
- Participant is willing and able to adhere to the procedures specified in thisprotocol. Cohort 2:
- Subjects diagnosed with moderate-severe atopic dermatitis who are receiving or havereceived in the past treatment with cyclosporine.
- Participants must be willing and able to provide written informed consent prior theinitiation of any study procedures.
- For children, parent/legal guardian must provide written informed consent. If age >11years old, the minor must give assent.
- Participant is willing and able to adhere to the procedures specified in thisprotocol.
Exclusion
Exclusion Criteria:
- Subjects participating in a clinical trial in the last three months.
- Any condition or situation precluding or interfering the compliance with the protocol.
- Women of childbearing potential must have a negative urine pregnancy test at Screeningand Day 0.
- Women of childbearing potential must commit not to become pregnant. They must bewilling to use highly effective contraceptive methods or have practiced sexualabstinence during the study. Highly effective contraceptive methods include oral,intravaginal, or transdermal combined (oestrogen and progestogen containing) hormonalcontraception associated with inhibition of ovulation; oral, injectable, orimplantable progestogen-only hormonal contraception associated with inhibition ofovulation; intrauterine device; intrauterine hormone-releasing system; bilateral tubalocclusion; vasectomised partner and sexual abstinence.
Study Design
Total Participants: 100
Study Start date:
October 10, 2022
Estimated Completion Date:
July 31, 2024
Study Description
Connect with a study center
Hospital La Paz
Madrid, 28046
SpainActive - Recruiting
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