Atopic Dermatitis
Conditions
Brief summary
This is a low-intervention phase IV trial. The main objective is to optimize the treatment of patients with moderate-severe atopic dermatitis that require systemic treatment after failure, intolerance or contraindication to cyclosporine.
Detailed description
Primary outcome is the percentage of patients with primary non-response to second-line treatment. 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 150 patients with moderate-severe atopic dermatitis will be recruited. The study is divided into two cohorts. All patients diagnosed with moderate to severe atopic dermatitis who are going to receive second-line systemic treatment at the Dermatology Department of La Paz University Hospital are selected in cohort 1. Patients will receive the starting dose used in routine clinical practice. All patients diagnosed with moderate to severe atopic dermatitis who are receiving second-line systemic treatment at the Dermatology Department of La Paz University Hospital will be selected in cohort 2.
Interventions
DRUGSecond-line systemic treatment
Patients with moderate to severe atopic dermatitis refractory to topical medication, who also have previous experience with cyclosporine and an unsatisfactory response, or in whom the use of cyclosporine is considered inappropriate due to contraindication or intolerance, are candidates for treatment with other alternatives (Dupilumab, Tralokinumab, Upadacitinib, Baricitinib, Abrocitinib).
OTHERFolllow-up of second-line systemic treatment already started
If the patient is receiving second-line therapy at the moment of the inclusion, data will be collected from clinical records from treatment start until study inclusion and prospectively after study inclusion.
Sponsors
Instituto de Investigación Hospital Universitario La Paz
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
Phase IV, low-intervention clinical trial to develop prediction models that allow to determine the most appropriate therapeutic strategy in patients diagnosed with atopic dermatitis that need second-line systemic treatment.
Eligibility
Sex/Gender
ALL
Healthy volunteers
No
Inclusion criteria
Cohort 1: 1. Subjects diagnosed with moderate-severe atopic dermatitis who are going to receive an authorized second-line systemic treatment. 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 already receiving authorized second-line systemic therapy at the time of selection. 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. Any investigational drug within 60 days prior to study drug administration. 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 (estrogen 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of patients with primary non-response to second-line treatment. | Week 16 | Fail to achieve EASI-75 (a 75% improvement in Eczema Area and Severity Index \[EASI\] score). The minimum EASI score is 0 and the maximum EASI score is 72. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Time to treatment failure after week 16 | Week 16 | Time to treatment failure with cyclosporine defined as Eczema Area and Severity Index (EASI) ≤ 50 during follow-up after week 16. |
| Mean percentage of change in Eczema Area and Severity Index (EASI) score | Week 16 | Mean percentage of change in EASI score from baseline to week 16. |
| Percentage of change in SCORAD (SCORing Atopic Dermatitis) | Week 16 | Is the score of the severity of atopic dermatitis. It includes the evaluation of the affected areas. The intensity of the lesions and the subjective symptoms of the patient. Classifies AD as Mild \>25, Moderate 25-50, and Severe \>50 |
| Improvement of at least 75% in SCORAD (SCORing Atopic Dermatitis) | Through study completion, an average of 1 year | Percentage of patients experiencing an improvement of at least 75% in SCORAD from the baseline value. The SCORAD for that individual is A/5 + 7B/2 + C. The total area is 'A', which has a possible maximum of 100%. The intensity scores are added together to give 'B' (maximum 18). The subjective symptoms is 'C' (maximum 20). |
| Change of IGA (Investigator Global Assessment) | Week 16 | Investigator Global Assessment (IGA) is a simple objective measure providing an overall evaluation. It uses a 5-point scale (clear=0; almost clear=1; mild=2; moderate=3; severe=4). |
| Time to IGA score of 0/1 (Investigator Global Assessment) | Through study completion, an average of 1 year | Time to IGA score of 0/1 (clear or almost clear). |
| Percentage of patients achieving EASI-75 | Week 6 | Fail to achieve EASI-75 (a 75% improvement in Eczema Area and Severity Index \[EASI\] score). The minimum EASI score is 0 and the maximum EASI score is 72. |
| Change in NRS | Week 16 | Change in NRS (numerical rating scale). The NRS is comprised of one item and represents the numbers 0 (no itch) to 10 (worst imaginable itch). |
| Change in RECAP | Week 16 | RECAP (Recap of atopic eczema) is used to assess the control of different degrees of eczema severity through 7 items. |
| Percentage of patients having a variation of 4 points in their improvement in DLQI | Through study completion, an average of 1 year | Dermatology Life Quality Index is a validated and widely used 10-item questionnaire with paediatric versions (0-3 and 4-16 years). A variation of 4 points is considered a clinically meaningful endpoint. |
| Change in POEM (Patient-Oriented Eczema Measure) | Week 16 | The Patient-Oriented Eczema Measure (POEM): is a validated tool in which the patient self-assesses how many days they experienced seven distinct items (itch, sleep disturbance, bleeding, weeping/oozing, cracking, flaking, dryness of the skin) during a period of 1 week. The maximum score is 28 points. |
| Rate of adverse events associated to second-line systemic treatment | Through study completion, an average of 1 year | Any untoward medical occurrence in a patient or clinical trial participant, which does not necessarily have a causal relationship with the research procedures or the investigational medicinal product. |
| Percentage of patients reaching EASI-90 (Percentage of patients reaching 90 percentage) | Through study completion, an average of 1 year | Percentage of patients reaching 90 percentage (EASI-90) improvement from baseline during follow-up. The minimum EASI (Eczema Area and Severity Index) score is 0 and the maximum EASI score is 72. |
| Change of BSA (Body surface area) | Week 16 | Change of BSA (Body surface area) involment |
Countries
Spain
Contacts
Primary ContactIrene García, MD
Outcome results
None listed