Atopic DermatitisPhase 4DermAtOmicsNCT05692843
Optimization of Cyclosporin in Atopic Dermatitis Through Multiomic Predictive Models of Treatment Response
A Phase 4 study testing Cyclosporin A and Follow-up of Cyclospoin treatment already started in people with Atopic Dermatitis, run by Instituto de Investigación Hospital Universitario La Paz at 1 site in Spain.
Trial 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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Atopic Dermatitis
- What is being tested?
- Cyclosporin A and Follow-up of Cyclospoin treatment already started
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteSpain
- Study dates
- 10 Oct 2022to Jul 2024
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Cohort 1:
- Subjects diagnosed with moderate-severe atopic dermatitis who are going to receive treatment with cyclosporine.
- Participants must be willing and able to provide written informed consent prior the initiation of any study procedures.
- For children, parent/legal guardian must provide written informed consent. If age >11 years old, the minor must give assent.
- Participant is willing and able to adhere to the procedures specified in this protocol.
- Cohort 2:
Show all 10Show fewer
- Subjects diagnosed with moderate-severe atopic dermatitis who are receiving or have received in the past treatment with cyclosporine.
- Participants must be willing and able to provide written informed consent prior the initiation of any study procedures.
- For children, parent/legal guardian must provide written informed consent. If age >11 years old, the minor must give assent.
- Participant is willing and able to adhere to the procedures specified in this protocol.
Who cannot join
- 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 Screening and Day 0.
- 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.
Trial locations and contacts
1 site in 1 country.
Spain1 site, 1 recruiting
- Recruiting
Hospital La Paz
Madrid, 28046
Alberto M Borobia, MD, PhD, MD, PhD, alberto.borobia@salud.madrid.org
About this study
Official title: Optimization of Cyclosporin Therapy in Atopic Dermatitis Through Multiomic Predictive Models of Treatment Response (DermAtOmics)
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.
Read the detailed 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.
- Conditions
- Atopic Dermatitis
- Being tested
- Cyclosporin A, Follow-up of Cyclospoin treatment already started
- Medical subject headings
- Dermatitis, Atopic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cyclosporin ADrug
Also called Prospective
Once the patient is included in the clinical trial their therapeutic management will be carried out according to usual clinical practice, but additional procedures will be performed:
- The frequency of follow-up visits will be increased in order to collect data related to clinical efficacy, safety and quality of life;
- Biological samples will be obtained (blood and urine) for biochemical, kinetic, pharmacogenetic and immunological biomarker analysis to identify variables associated to CsA treatment.
Follow-up of Cyclospoin treatment already startedOther
Also called Ambispective
If the patient is receiving cyclosporine therapy, a blood sample for pharmacogenetic analysis will be obtained at screening; also, at discretion of the treating physician, biological samples will be obtained (blood and urine) in this visit and in the follow-up visits to assess biochemical and kinetic variables. Clinical data (scales) will be collected from clinical records from treatment start until study inclusion and prospectively after study inclusion.
If the patient received cyclosporine previously but is no longer under CsA therapy, a blood sample will be extracted at screening for pharmacogenetic analysis. Clinical data (scales) will be collected from clinical records.
| Study group | Role | What they receive |
|---|---|---|
| Start of Cyclosporin treatment | Other | Patients will receive the starting dose used in routine clinical practice (maximum dose of 3 mg/kg/day is standard practice in our center).
Once the patient is included in the clinical trial their therapeutic management will be carried out according to usual clinical practice, but additional procedures will be performed:
1. The frequency of follow-up visits will be increased in order to collect data related to clinical efficacy, safety and quality of life;
2. Biological samples will be obtained (blood and urine) for biochemical, kinetic, pharmacogenetic and immunological biomarker analysis to identify variables associated to CsA treatment. Receives: Drug: Cyclosporin A |
| Receiving or received cyclosporin | Other | If the patient is receiving cyclosporine therapy, a blood sample for pharmacogenetic analysis will be obtained at screening; also, at discretion of the treating physician, biological samples will be obtained (blood and urine) in this visit and in the follow-up visits to assess biochemical and kinetic variables. Clinical data (scales) will be collected from clinical records from treatment start until study inclusion and prospectively after study inclusion.
If the patient received cyclosporine previously but is no longer under CsA therapy, a blood sample will be extracted at screening for pharmacogenetic analysis. Clinical data (scales) will be collected from clinical records. Receives: Other: Follow-up of Cyclospoin treatment already started |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of patients with primary non-response to treatment with cyclosporine.
Fail to achieve EASI-75 (a 75% improvement in EASI score)
Measured: Week 16
Secondary outcomes (14)
Percentage of patients achieving EASI-75
Fail to achieve EASI-75 (a 75% improvement in EASI score)
Measured: week 6
Percentage of patients reaching EASI-90
Percentage of patients reaching 90 percentage (EASI-90) improvement from baseline during follow-up
Measured: through study completion, an average of 1 year
Time to treatment failure after week 16
Time to treatment failure with cyclosporine defined as EASI ≤ 50 during follow-up after week 16.
Measured: Week 24, week 32, week 40, week 48.
Mean percentage of change in EASI score
Mean percentage of change in EASI score from baseline to week 16
Measured: Week 16
Percentage of change in SCORAD
The Scoring of Atopic Dermatitis (SCORAD) 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
Measured: Week 16
improvement of at least 75% in SCORAD
Percentage of patients experiencing an improvement of at least 75% in SCORAD from the baseline value
Measured: through study completion, an average of 1 year
Change of IGA
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).
Measured: week 16
Time to IGA score of 0/1
Time to IGA score of 0/1 (clear or almost clear)
Measured: through study completion, an average of 1 year
Change of BSA
Change of BSA (Body surface area) involment
Measured: week 16
Change in NRS
NRS (Numerical Rating Scale) is a numerical scale that measures the intensity of pruritus, with 10 being the greatest intensity
Measured: week 16
Change in POEM
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.
Measured: week 16
Change in DLQI
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.
Measured: week 16
Percentage of patients having a variation of 4 points in their improvement in DLQI
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.
Measured: through study completion, an average of 1 year
Rate of adverse events associated to CsA treatment
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
Measured: through study completion, an average of 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jan 2023
- Study start10 Oct 2022
- Primary completionNov 2023 (estimated)
- Study completionJul 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Atopic DermatitisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Model description
- Non-randomized clinical trial. The intervention consists in additional follow-up visits out of usual clinical practice. According to RD 1090/2015 of December 4, which regulates clinical trials with drugs, it is considered a low level intervention clinical.
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Instituto de Investigación Hospital Universitario La Paz
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Alberto M Borobia, MD, PhD, Principal investigator, Hospital la Paz
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05692843
- Sponsor's protocol ID
- 2022-500677-14-00
- Acronym
- DermAtOmics
- Status last verified
- Apr 2023
- First submitted
- 24 Dec 2022
- Last updated
- 28 Apr 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: A copy of the database of data collected during the clinical trial will be attached as an appendix to the publication resulting from this clinical trial.
Publications
Marin-Candon A, Garcia-Garcia I, Arias P, Carcas AJ, Diaz-Garcia L, Feltes Ochoa R, Hernandez Cano N, Herranz Pinto P, Jimenez Gonzalez M, Lopez-Granados E, Martinez-Feito A, Mayor-Ibarguren A, Rosas-Alonso R, Seco-Meseguer E, Borobia AM. Identifying biomarkers of treatment response to ciclosporin in atopic dermatitis through multiomic predictive modelling: DERMATOMICS study protocol. BMJ Open. 2023 Jul 10;13(7):e072350. doi: 10.1136/bmjopen-2023-072350.
PubMed 37429687
Study at a glance
From the registry record, last updated by the sponsor on 28 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Optimization of Cyclosporin Therapy in Atopic Dermatitis Through Multiomic Predictive Models of Treatment Response (DermAtOmics)
- ClinicalTrials.gov ID
- NCT05692843
- Acronym / sponsor ID
- DermAtOmics / 2022-500677-14-00
- Conditions
- Atopic Dermatitis
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Instituto de Investigación Hospital Universitario La PazUniversity, hospital or other
- Study start
- 10 Oct 2022 (actual)
- Primary completion
- Nov 2023 (estimated)
- Study completion
- Jul 2024 (estimated)
- First posted
- 20 Jan 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Non-randomized clinical trial. The intervention consists in additional follow-up visits out of usual clinical practice. According to RD 1090/2015 of December 4, which regulates clinical trials with drugs, it is considered a low level intervention clinical.
| Arm | Type | Receives |
|---|---|---|
| Start of Cyclosporin treatment | Other | Drug: Cyclosporin APatients will receive the starting dose used in routine clinical practice (maximum dose of 3 mg/kg/day is standard practice in our center). Once the patient is included in the clinical trial their therapeutic management will be carried out according to usual clinical practice, but additional procedures will be performed: 1. The frequency of follow-up visits will be increased in order to collect data related to clinical efficacy, safety and quality of life; 2. Biological samples will be obtained (blood and urine) for biochemical, kinetic, pharmacogenetic and immunological biomarker analysis to identify variables associated to CsA treatment. |
| Receiving or received cyclosporin | Other | Other: Follow-up of Cyclospoin treatment already startedIf the patient is receiving cyclosporine therapy, a blood sample for pharmacogenetic analysis will be obtained at screening; also, at discretion of the treating physician, biological samples will be obtained (blood and urine) in this visit and in the follow-up visits to assess biochemical and kinetic variables. Clinical data (scales) will be collected from clinical records from treatment start until study inclusion and prospectively after study inclusion. If the patient received cyclosporine previously but is no longer under CsA therapy, a blood sample will be extracted at screening for pharmacogenetic analysis. Clinical data (scales) will be collected from clinical records. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (10 listed)
- Subjects diagnosed with moderate-severe atopic dermatitis who are going to receive treatment with cyclosporine.
- Participants must be willing and able to provide written informed consent prior the initiation of any study procedures.
- For children, parent/legal guardian must provide written informed consent. If age >11 years old, the minor must give assent.
- Participant is willing and able to adhere to the procedures specified in this protocol.
- Subjects diagnosed with moderate-severe atopic dermatitis who are receiving or have received in the past treatment with cyclosporine.
Key exclusion criteria (4 listed)
- 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 Screening and Day 0.
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Cyclosporin AAlso: ProspectiveOnce the patient is included in the clinical trial their therapeutic management will be carried out according to usual clinical practice, but additional procedures will be performed: 1. The frequency of follow-up visits will be increased in order to collect data related to clinical efficacy, safety and quality of life; 2. Biological samples will be obtained (blood and urine) for biochemical, kinetic, pharmacogenetic and immunological biomarker analysis to identify variables associated to CsA treatment. | Drug | Start of Cyclosporin treatment |
| Follow-up of Cyclospoin treatment already startedAlso: AmbispectiveIf the patient is receiving cyclosporine therapy, a blood sample for pharmacogenetic analysis will be obtained at screening; also, at discretion of the treating physician, biological samples will be obtained (blood and urine) in this visit and in the follow-up visits to assess biochemical and kinetic variables. Clinical data (scales) will be collected from clinical records from treatment start until study inclusion and prospectively after study inclusion. If the patient received cyclosporine previously but is no longer under CsA therapy, a blood sample will be extracted at screening for pharmacogenetic analysis. Clinical data (scales) will be collected from clinical records. | Other | Receiving or received cyclosporin |
Primary outcome
Percentage of patients with primary non-response to treatment with cyclosporine.
Time frame: Week 16
Fail to achieve EASI-75 (a 75% improvement in EASI score)
14 secondary outcomes
Percentage of patients achieving EASI-75
Time frame: week 6
Percentage of patients reaching EASI-90
Time frame: through study completion, an average of 1 year
Time to treatment failure after week 16
Time frame: Week 24, week 32, week 40, week 48.
Mean percentage of change in EASI score
Time frame: Week 16
Percentage of change in SCORAD
Time frame: Week 16
improvement of at least 75% in SCORAD
Time frame: through study completion, an average of 1 year
Change of IGA
Time frame: week 16
Time to IGA score of 0/1
Time frame: through study completion, an average of 1 year
Change of BSA
Time frame: week 16
Change in NRS
Time frame: week 16
Change in POEM
Time frame: week 16
Change in DLQI
Time frame: week 16
Percentage of patients having a variation of 4 points in their improvement in DLQI
Time frame: through study completion, an average of 1 year
Rate of adverse events associated to CsA treatment
Time frame: through study completion, an average of 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Apr 2023.
- Derived from this study: PubMed 37429687Marin-Candon A, Garcia-Garcia I, Arias P, Carcas AJ, Diaz-Garcia L, Feltes Ochoa R, Hernandez Cano N, Herranz Pinto P, Jimenez Gonzalez M, Lopez-Granados E, Martinez-Feito A, Mayor-Ibarguren A, Rosas-Alonso R, Seco-Meseguer E, Borobia AM. Identifying biomarkers of treatment response to ciclosporin in atopic dermatitis through multiomic predictive modelling: DERMATOMICS study protocol. BMJ Open. 2023 Jul 10;13(7):e072350. doi: 10.1136/bmjopen-2023-072350.
- Individual participant dataSharing planned: Yes. A copy of the database of data collected during the clinical trial will be attached as an appendix to the publication resulting from this clinical trial.
Related trials for Atopic Dermatitis
RecruitingPhase 2
Cardamom and Topical Roseomonas in Atopic Dermatitis
Atopic Dermatitis, Eczema
RecruitingPhase 1
Evaluating the Safety and Tolerability of Baricitinib in Patients With Job Syndrome With Lupus-Like Disease and/or Atopic Dermatitis
Hyper IgE Syndrome From STAT3 Mutation, Job s Syndrome
RecruitingObservational study
Studies of Skin Microbes in Healthy People and in People With Skin Conditions
Eczema, Atopic Dermatitis
RecruitingPhase 2
Effects of Treatments on Atopic Dermatitis
Eczema, Dermatitis
RecruitingObservational study
Natural History and Genetics of Food Allergy and Related Conditions
Food Allergy, Loeys-Dietz Syndrome
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Alberto M Borobia, MD, PhD principal investigator
Hospital la Paz
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Cyclosporin A and Follow-up of Cyclospoin treatment already started in people with Atopic Dermatitis, run by Instituto de Investigación Hospital Universitario La Paz at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 28 Apr 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Alberto M Borobia, MD, PhD (+34-917277558, alberto.borobia@salud.madrid.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of patients with primary non-response to treatment with cyclosporine. (time frame: Week 16). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05692843, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Apr 2023.