Dermatitis, AtopicDermatitisNCT05078294
Results in Real Clinical Practice of Treatment of Moderate-severe Atopic Dermatitis
An observational study of Dermatitis, Atopic, run by Fundación Pública Andaluza para la gestión de la Investigación en Sevilla at 7 sites in Spain.
Trial summary
The purpose of this study is to determine the efficacy results in terms of percentage improvement of the Eczema Area and Severity Index (EASI) as well as on the scale Patient Global Assessment (PGA) throughout the follow-up of patients undergoing subjected to systemic and/or biological treatments in conditions of… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Dermatitis, Atopic
- How many people
- 300 participants
- Where
- 7 sitesSpain
- Study dates
- 1 Aug 2021to 1 Nov 2024
- Phase
- Observational
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: The study population would be patients older than 18 years who suffer from the disease and are being treated with a systemic therapy.
Who may be able to join
- Over 18 years.
- Patients treated with any systemic therapy (other than topical therapy) according to criteria clinical and routine clinical practice. Therefore, the treatments included will be: phototherapy, cyclosporine, methotrexate, azathioprine, mycophenolate, dupilumab, baricitinib, upadacitinib and tralokilumab.
- Patients who grant informed consent.
Who cannot join
- Patients who do not have the necessary comprehension capacity to understand and sign the informed consent.
- Patients who, according to routine clinical practice, require only topical treatment.
Trial locations and contacts
7 sites in 1 country.
7 sites in 1 country
Spain7 sites, 7 recruiting
- Recruiting
Hospital General Universitario de Alicante
Alicante, 03010
Juan Francisco Silvestre Salvador, 965 93 30 00
Juan Francisco Silvestre Salvador
- Recruiting
Hospital Sant Pau
Barcelona, 08041
Esther Serra-Baldrich, 93 291 90 00
Esther Serra-Baldrich
- Recruiting
Hospital General de Granollers
Granollers, Barcelona, 08402
Antonio Guilabert Vidal, 938 42 50 00
Antonio Guilabert Vidal
- Recruiting
Hospital Universitario Puerta de Hierro
Majadahonda, Madrid, 28222
Marta Elosua González, 911 91 60 00
Ángel Rosell Díaz
- Recruiting
Hospital Universitario Puerta Real
Puerto Real, Cádiz, 11510
José Carlos Armario Hita, 956 00 50 00
José Carlos Armario Hita
- Recruiting
Hospital Universitario Virgen del Rocío
Seville, 41013
José Juan Pereyra Rodríguez, 955 01 20 00, josej.pereyra.sspa@juntadeandalucia.es
José Juan Pereyra Rodríguez
- Recruiting
Hospital Arnau de Vilanova
Valencia, 46015
Francisco Javier Miquel Miquel, 961 97 60 00
Francisco Javier Miquel Miquel
About this study
Official title: Results in Real Clinical Practice of Treatment With Patients With Moderate-severe Atopic Dermatitis
The purpose of this study is to determine the efficacy results in terms of percentage improvement of the Eczema Area and Severity Index (EASI) as well as on the scale Patient Global Assessment (PGA) throughout the follow-up of patients undergoing subjected to systemic and/or biological treatments in conditions of usual clinical practice. Likewise, collect safety data, recording adverse events related to medication.
Read the detailed description
This is an observacional follow-up study, open-label (all people know the identity of the intervention), prospective (study following participants forward in time), multi-center study in adult participants with moderate to severe atopic dermatitis. A registration can also be made retrospective data from the patient's medical history.
Participants will be treated with one of this therapy (phototherapy, cyclosporine, methotrexate, azathioprine, mycophenolate, dupilumab, baricitinib, upadacitinib or tralokilumab).
A series of variables will be measured (basal surface area affected (BSA), Eczema Area and Severity Index (EASI), numbers of shoots, analytical determinations and current treatment and adverse effects occurred) in order to observe the changes in the improvement of the disease. Questionnaires will also be carried out to analyze whether the drug acts favorably in improving the disease. Questionnaires like Dermatology Life Quality Index (DLQI), Patient Global Assesment (PGA) and Patient Oriented SCOring Atopic Dermatitis (PO-SCORAD).
- Conditions
- Dermatitis, Atopic
- Medical subject headings
- Dermatitis, Atopic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Cases | Patients treated as monotherapy with phototherapy, cyclosporine, methotrexate, azathioprine, mycophenolate, dupilumab, baricitinib, upadacitinib, or tralokilumab for the treatment of moderate to severe atopic dermatitis. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of participants who showed a change in disease severity.
Percentage improvement in Eczema Area and Severity Index (EASI) throughout the follow-up of patients undergoing systemic treatments and/or biological.
Measured: Up to 30 weeks
Secondary outcomes (2)
Medication-related adverse effect rate.
Number of adverse effects.
Measured: Up to 30 weeks
Evaluation of quality of life parameters.
Completion of the self-administered dermatology quality of life index questionnaire, which measures the quality of life of the patient.
Numerical variable (range 0-30) obtained from a self-administered questionnaire already validated in Spanish, which measures the quality of life of surveyed, consisting of 10 questions.
Measured: Up to 30 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Oct 2021
- Study start1 Aug 2021
- Primary completion1 Jun 2024 (estimated)
- Study completion1 Nov 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Dermatitis, AtopicStudies 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
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fundación Pública Andaluza para la gestión de la Investigación en Sevilla
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- José Juan Pereyra Rodríguez, Principal investigator, Hospitales Universitarios Virgen del Rocío
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05078294
- Sponsor's protocol ID
- FIS-DER-2021-01
- Acronym
- Dermatitis
- Status last verified
- Sep 2021
- First submitted
- 9 Sep 2021
- Last updated
- 17 Nov 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Nov 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Results in Real Clinical Practice of Treatment With Patients With Moderate-severe Atopic Dermatitis
- ClinicalTrials.gov ID
- NCT05078294
- Acronym / sponsor ID
- Dermatitis / FIS-DER-2021-01
- Conditions
- Dermatitis, Atopic
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- Fundación Pública Andaluza para la gestión de la Investigación en SevillaUniversity, hospital or other
- Study start
- 1 Aug 2021 (actual)
- Primary completion
- 1 Jun 2024 (estimated)
- Study completion
- 1 Nov 2024 (estimated)
- First posted
- 14 Oct 2021 (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.
The purpose of this study is to determine the efficacy results in terms of percentage improvement of the Eczema Area and Severity Index (EASI) as well as on the scale Patient Global Assessment (PGA) throughout the follow-up of patients undergoing subjected to systemic and/or biological treatments in conditions of usual clinical practice. Likewise, collect safety data, recording adverse events related to medication.
Detailed description
This is an observacional follow-up study, open-label (all people know the identity of the intervention), prospective (study following participants forward in time), multi-center study in adult participants with moderate to severe atopic dermatitis. A registration can also be made retrospective data from the patient's medical history.
Participants will be treated with one of this therapy (phototherapy, cyclosporine, methotrexate, azathioprine, mycophenolate, dupilumab, baricitinib, upadacitinib or tralokilumab).
A series of variables will be measured (basal surface area affected (BSA), Eczema Area and Severity Index (EASI), numbers of shoots, analytical determinations and current treatment and adverse effects occurred) in order to observe the changes in the improvement of the disease. Questionnaires will also be carried out to analyze whether the drug acts favorably in improving the disease. Questionnaires like Dermatology Life Quality Index (DLQI), Patient Global Assesment (PGA) and Patient Oriented SCOring Atopic Dermatitis (PO-SCORAD).
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Cases | – | –Patients treated as monotherapy with phototherapy, cyclosporine, methotrexate, azathioprine, mycophenolate, dupilumab, baricitinib, upadacitinib, or tralokilumab for the treatment of moderate to severe atopic dermatitis. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The study population would be patients older than 18 years who suffer from the disease and are being treated with a systemic therapy.
Key inclusion criteria (3 listed)
- Over 18 years.
- Patients treated with any systemic therapy (other than topical therapy) according to criteria clinical and routine clinical practice. Therefore, the treatments included will be: phototherapy, cyclosporine, methotrexate, azathioprine, mycophenolate, dupilumab, baricitinib, upadacitinib and tralokilumab.
- Patients who grant informed consent.
Key exclusion criteria (2 listed)
- Patients who do not have the necessary comprehension capacity to understand and sign the informed consent.
- Patients who, according to routine clinical practice, require only topical treatment.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Number of participants who showed a change in disease severity.
Time frame: Up to 30 weeks
Percentage improvement in Eczema Area and Severity Index (EASI) throughout the follow-up of patients undergoing systemic treatments and/or biological.
2 secondary outcomes
Medication-related adverse effect rate.
Time frame: Up to 30 weeks
Evaluation of quality of life parameters.
Time frame: Up to 30 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Nov 2021.
Related trials for Dermatitis, Atopic
Not yet recruitingPhase 1
A Phase I Study of GLR2053 Tablets in Chinese Healthy Adult Participants
Atopic Dermatitis
RecruitingObservational study
Blood, Urine, and Tissue Collection for Cutaneous Lymphoma, Eczema, and Atopic Dermatitis Research
Cutaneous T-cell Lymphoma, Sezary Syndrome
RecruitingPhase 1
First-in-Human Trial to Assess REGN20423 in Healthy Adult Participants and Adult Participants With Atopic Dermatitis
Healthy Volunteer, Atopic Dermatitis
Not yet recruitingPhase 1
A Study of HSK60002 Tablets in Participants With Moderate-to-Severe Atopic Dermatitis
Dermatitis Atopic
RecruitingPhase 3
A Study to Learn About the Study Medicine Called Tilrekimig in People With Moderate-to Severe Eczema
Atopic Dermatitis
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.
José Juan Pereyra Rodríguez principal investigator
Hospitales Universitarios Virgen del Rocío
7 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Dermatitis, Atopic, run by Fundación Pública Andaluza para la gestión de la Investigación en Sevilla at 7 sites 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 3 inclusion and 2 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 17 Nov 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites 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.
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 José Juan Pereyra Rodríguez (955 01 20 00, josej.pereyra.sspa@juntadeandalucia.es), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of participants who showed a change in disease severity. (time frame: Up to 30 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 17 Nov 2021.