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

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/A

Clinical Study ID

NCT05692843
2022-500677-14-00
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria: Cohort 1:

  1. Subjects diagnosed with moderate-severe atopic dermatitis who are going to receivetreatment with cyclosporine.
  2. Participants must be willing and able to provide written informed consent prior theinitiation of any study procedures.
  3. For children, parent/legal guardian must provide written informed consent. If age >11years old, the minor must give assent.
  4. Participant is willing and able to adhere to the procedures specified in thisprotocol. Cohort 2:
  5. Subjects diagnosed with moderate-severe atopic dermatitis who are receiving or havereceived in the past treatment with cyclosporine.
  6. Participants must be willing and able to provide written informed consent prior theinitiation of any study procedures.
  7. For children, parent/legal guardian must provide written informed consent. If age >11years old, the minor must give assent.
  8. Participant is willing and able to adhere to the procedures specified in thisprotocol.

Exclusion

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 Screeningand Day 0.
  4. 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

Primary outcome is the percentage of patients with primary non- response to treatment with cyclosporin. 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 of 100 patients with moderate-severe atopic dermatitis will be recruited. The study is divided into two cohorts. All patients diagnosed with moderate-severe atopic dermatitis who are going to receive treatment with cyclosporin in the Dermatology Service of La Paz University Hospital and associated Specialty Centers are selected in cohort 1. Patients will receive the starting dose used in routine clinical practice. All patients diagnosed with moderate-severe atopic dermatitis who are receiving or have received cyclosporin therapy in the Dermatology Service of La Paz University Hospital and associated Specialty Centers are selected in cohort 2.

Connect with a study center

  • Hospital La Paz

    Madrid, 28046
    Spain

    Active - Recruiting

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