. 2023 Jul 10;13(7):e072350. doi: 10.1136/bmjopen-2023-072350

Table 1.

Inclusion and exclusion criteria for participating in the DermAtOmics trial

Inclusion criteria	Exclusion criteria
Cohort 1: Subjects diagnosed with moderate-severe atopic dermatitis who are going to receive treatment with ciclosporine. Participants must be willing and able to provide written informed consent prior to the initiation of any study procedure. For children, a parent/legal guardian must provide written informed consent. If aged >11 years, the minor must give assent. Participants willing and able to adhere to the procedures specified in this protocol. Cohort 2: Subjects diagnosed with moderate-severe atopic dermatitis who are receiving or have received treatment with ciclosporine in the past. Participants must be willing and able to provide written informed consent prior to the initiation of any study procedure. For children, a parent/legal guardian must provide written informed consent. If aged >11 years, the minor must give assent. Participants willing and able to adhere to the procedures specified in this protocol.	Subjects participating in a clinical trial in the last 3 months. Any condition or situation precluding or interfering with compliance with the protocol. Persons of childbearing potential with a positive urine pregnancy test at screening and day 0. Persons of childbearing potential who do not agree not to become pregnant. They must be willing to use highly effective contraceptive methods or practice 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 ligation; vasectomised partner and sexual abstinence.

Inclusion criteria

Exclusion criteria

Cohort 1:

Subjects diagnosed with moderate-severe atopic dermatitis who are going to receive treatment with ciclosporine.
Participants must be willing and able to provide written informed consent prior to the initiation of any study procedure.
For children, a parent/legal guardian must provide written informed consent. If aged >11 years, the minor must give assent.
Participants willing and able to adhere to the procedures specified in this protocol.

Cohort 2:

Subjects diagnosed with moderate-severe atopic dermatitis who are receiving or have received treatment with ciclosporine in the past.
Participants must be willing and able to provide written informed consent prior to the initiation of any study procedure.
For children, a parent/legal guardian must provide written informed consent. If aged >11 years, the minor must give assent.
Participants willing and able to adhere to the procedures specified in this protocol.

Subjects participating in a clinical trial in the last 3 months.
Any condition or situation precluding or interfering with compliance with the protocol.
Persons of childbearing potential with a positive urine pregnancy test at screening and day 0.
Persons of childbearing potential who do not agree not to become pregnant. They must be willing to use highly effective contraceptive methods or practice 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 ligation; vasectomised partner and sexual abstinence.