Psoriasis VulgarisNCT04220554
Improvement of Psoriasis Patients' Adherence to Topical Drugs
A study testing Improved support by health-care professionals in people with Psoriasis Vulgaris, run by Odense University Hospital at 1 site in Denmark.
Trial summary
Psoriasis affects 2-4% of the Western adult population and is a socio-economic burden for patients and society. Topical drugs are recommended as first-line treatment for mild-to-moderate psoriasis, but low adherence is a barrier for treatment success. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Psoriasis Vulgaris
- What is being tested?
- Improved support by health-care professionals
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 103 participants
- Where
- 1 siteDenmark
- Study dates
- 19 Jun 2020to 1 Jun 2022
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Inclusion Criteria: Legally competent patients with milder-to-moderate psoriasis
Exclusion Criteria: Incapable patients not diagnosed with psoriasis
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Long-term Improvement of Psoriasis Patients' Adherence to Topical Drugs: Testing a Patient-supporting Intervention Delivered by Healthcare Professionals
Psoriasis affects 2-4% of the Western adult population and is a socio-economic burden for patients and society. Topical drugs are recommended as first-line treatment for mild-to-moderate psoriasis, but low adherence is a barrier for treatment success. There is a need for improved patient support for psoriasis patients, which is suggested to improve long-term use of topical drugs.
The project aims to test whether a patient-supporting intervention delivered by healthcare professionals can improve the use of topical drugs. The intervention design is based on experiences with previous adherence-improving studies consisting of digital support by conducting a systematic literature search and holding focus groups with patients as well as healthcare professionals. The intervention consists of shared decision-making with patients, nurses and doctors, frequent consultations, easy access to healthcare professionals through video or in-office consultations and holding patients accountable for taking the medication.
Read more
The intervention will be tested in a randomized controlled trial: during a 48 week period, a group of patients (18-85 years of age) diagnosed with mild-to-moderate psoriasis and treated with topical drugs will be randomized to an intervention (n=40) or non-intervention group (n=40). The primary outcome will be severity of psoriasis and secondary outcomes primary adherence (i.e., rate of filled prescriptions) and quality of life.
If the intervention can reduce the severity of psoriasis in a significant manner, there is a potential for a national implementation of the intervention.
Read the detailed description
Background Psoriasis is a chronic inflammatory skin disease affecting 2-4% of the Western adult population. It is associated with many comorbidities, negatively affects quality of life and is a socioeconomic burden for patients and society. Topical drugs are the recommended first-line treatment for mild-to-moderate psoriasis, but adherence rates are low, which is a barrier for treatment success, resulting in a need for systemic or biological treatments, which are associated with more severe adverse events and are more expensive than topical drugs. However, improved adherence to topical drugs is associated with improved efficacy. That is why there is a need for improving psoriasis patients' adherence to topical drugs.
As a supplement to the introduction of new and advanced technology, there is a need for more studies on how to optimize the available healthcare professionals in dermatology clinics. Since dermatologists are a limited resource, there is a need to study how other healthcare professionals, e.g., hospital nurses and pharmaconomists at the pharmacies, can support psoriasis patients in their use of topical drugs.
Hypothesis
A patient-supporting intervention delivered by dermatologists, dermatology nurses and pharmaconomists significantly reduces psoriasis patients' severity of psoriasis compared to standard patient support.
Aims
The aim of the project is to test whether an individualized patient-supporting intervention delivered to psoriasis patients by dermatologists, nurses and pharmaconomists at a dermatology hospital clinic can: 1) reduce the severity of psoriasis, 2) improve quality of life, and 3) improve adherence to prescribed topical drugs.
Ethical considerations
All participants will be fully informed of the purpose of the study, and the study will be performed in accordance with the ethical principles in the Belmont report.
Materials and methods
The study is an investigator-initiated, single-centre, assessor-blinded, parallel group superiority randomized clinical study. Before inclusion of study participants, the study will be approved by the local regional ethics committee.
We will include patients (18-85 years of age) with milder-to-moderate psoriasis.
Outcomes
Outcome measurements will be either patient-reported or assessor-blinded.
Adherence measurements
Primary adherence: Proportion of filled topical prescriptions.
Secondary adherence:
Amount of medication used according to weight of the remains in the used medication packages. Data will be assessed week 48.
Disease severity measurements
Disease severity will be measured by Lattice-System Physician's Global Assessment (LS-PGA) (15), and the quality of life will be measured by the Dermatology Life Quality Index (DLQI). This data will be assessed at baseline, weeks 12, 24, 36 and 48.
Recruitment
Psoriasis patients who use topical treatments and are referred to the Department of Dermatology at Odense University Hospital will be recruited to the project until there is a sufficient number of participants included (n=100).
Hypothesis and expected number of participants
Our null hypothesis is that there is no difference in reduction of psoriasis between the intervention and non-intervention groups.
The sample size was calculated based on data from a previous project with consumption data for the use of prescribed calcipotriol betamethasone dipropionate cutaneous foam over 4 weeks. We expect an 20% difference in the LS-PGA, power 80%, two-sided significance of 95%, allocation of 1: 1 and an expected dropout rate of 25%. When using an unpaired t-test, the calculation resulted in the inclusion of a sample size consisting of 80 participants.
Blinding and randomization
Blinding of the data assessors: When the data assessor obtains baseline data from the study participants, it will be entered by an electronic data collection tool.
Participants will be allocated 1: 1 to an intervention or non-intervention arm via a computer-generated block randomization. The data assessor will be blinded to the allocation.
Statistics
Analysis of the primary outcome: changes in LS-PGA
Changes in LS-PGA measurements from baseline to weeks 12 and from baseline to weeks 24, 36 and 48 will be compared between the two groups by linear mixed model for longitudinal data. LS-PGA will be presented in box plots. As a sensitivity analysis on LS-PGA, the analysis will be carried out excluding missing data and after 100 times multiple imputations by multivariate normal regression on LS-PGA data, without included covariates in addition to with an imputation including treatment, age, sex and smoking as covariates.
Analysis of secondary outcomes: Changes in DLQI and adherence
Changes in DLQI measurements from baseline to weeks 12, 24, 36 and 48 will be compared between the two groups by linear mixed model for longitudinal data. DLQI will be presented in box plots.
For the analysis of adherence (by filled prescriptions, weight and patient reported), we will dichotomize adherence rate with a selected cut-off of 80%, with adherence rates above 80% considered adherent (a cut-off typically used when studying adherence in chronic diseases) [7, 42]. We will compare the dichotomized adherences by using logistic regression.
The statistical analysis will be conducted by an experienced statistician blinded to the intervention. An interim analysis is not planned.
Discussion
This study will demonstrate whether an individualized, optimized patient support delivered by doctors, nurses and pharmaconomists to dermatological patients can optimize the use of topical treatment, reduce the severity of psoriasis and have socioeconomic benefits compared to standard treatment. If the study shows that individualized and optimized patient support is effective, it is intended for the intervention to be implemented in the clinic. In addition, we will work on implementing the intervention nationally by a translational process.
Results from the study may also be referred to other chronic dermatological disorders. The study may be used methodically as a model for additional research projects investigating medical adherence in other chronic skin diseases.
- Conditions
- Psoriasis Vulgaris
- Being tested
- Improved support by health-care professionals
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Improved support by health-care professionalsOther
Improved support to patients prescribed topical antipsoriatic drugs
| Study group | Role | What they receive |
|---|---|---|
| Intervention group | Experimental | Intervention group:
All participants will be instructed how to use of the medication according to "the fingertip unit for topical steroids". All participants will be prescribed topical drugs based on shared decision between the prescriber and patient. The topical drugs will be either moderate corticosteroids (clobetasone-17-butyrate or hydrocortisone-17-butyrate), potent corticosteroids (betamethasone-17-valerate and betamethasone, mometasone furoate, fluocinolone acetonide or fluocinonide), very potent corticosteroids (clobetasol propionate), corticosteroids with antimicrobials (betamethasone and clioquinol, betamethasone and fusidic acid or fluocinolone acetonide and clioquinol), corticosteroid with calcipotriol or calcipotriol cream.
During the study period, a nurse or pharmaconomist will deliver;
* Improved support and instructions to the patients
* Patients will receive a diary and access to more consultations. Receives: Other: Improved support by health-care professionals |
| Non-intervention group | No intervention | All participants will be instructed how to use of the medication according to "the fingertip unit for topical steroids". All participants will be prescribed topical drugs based on shared decision between the prescriber and patient. The topical drugs will be either moderate corticosteroids (clobetasone-17-butyrate or hydrocortisone-17-butyrate), potent corticosteroids (betamethasone-17-valerate and betamethasone, mometasone furoate, fluocinolone acetonide or fluocinonide), very potent corticosteroids (clobetasol propionate), corticosteroids with antimicrobials (betamethasone and clioquinol, betamethasone and fusidic acid or fluocinolone acetonide and clioquinol), corticosteroid with calcipotriol or calcipotriol cream. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Severity of Psoriasis
Lattice-System Physician's Global Assessment (LS-PGA) (interval scale). From value 1 (no visible psoriasis) to 8 (severely affected by psoriasis).
Measured: Change from baseline at week 48
Secondary outcomes (2)
Secondary Adherence
Proportion of expected consumed amount of topical drugs.
Secondary adherence was calculated by combining measured amount of medication used (determined by the weight of the remains in the used medication packages) per body surface area unit affected.
Estimated recommended consumption of medication was 0.5 g per day multiplied by the estimated mean body surface area (BSA) during the whole study period, calculated from BSA measures at baseline and at weeks 12, 24, 36, and 48.
Measured: Week 48
Quality of Life (QOL)
Dermatology Life Quality Index (DLQI) (interval scale). From value 0 (no impact on quality of life) to 30 (severe impact on quality of life).
Measured: Change from baseline to week 48
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jan 2020
- Study start19 Jun 2020
- Primary completion16 Sep 2021
- Study completion1 Jun 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Psoriasis VulgarisStudies of the same condition, open and under way.
- More trials run by Odense University HospitalThe sponsor's other registered studies.
- 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 N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 103 participants (actual)
Sponsor and investigators
- Lead sponsor
- Odense University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mathias Tiedemann Svendsen, Odense University Hospital
- Investigators
- Mathias T Svendsen, MD, PhD, Principal investigator, Odense University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04220554
- Sponsor's protocol ID
- LF-OC-000048
- Status last verified
- Jan 2024
- First submitted
- 6 Dec 2019
- Last updated
- 30 Jan 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Svendsen MT, Feldman SR, Moller S, Kongstad LP, Andersen KE. Long-term improvement of psoriasis patients' adherence to topical drugs: testing a patient-supporting intervention delivered by healthcare professionals. Trials. 2021 Oct 25;22(1):742. doi: 10.1186/s13063-021-05707-6.
PubMed 34696820Svendsen MT, Feldman SR, Mejldal A, Moller S, Kongstad LP, Andersen KE. Regular support provided by dermatological nurses improves outcomes in patients with psoriasis treated with topical drugs: a randomized controlled trial. Clin Exp Dermatol. 2022 Dec;47(12):2208-2221. doi: 10.1111/ced.15370. Epub 2022 Oct 25.
PubMed 35973788Svendsen MT, Andersen KE, Feldman SR, Mejldal A, Moller S, Kongstad LP. An effective patient-supporting intervention for topical treatment of psoriasis is also cost-effective. Clin Exp Dermatol. 2023 Oct 25;48(11):1247-1254. doi: 10.1093/ced/llad272.
PubMed 37585448
Study at a glance
From the registry record, last updated by the sponsor on 30 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Long-term Improvement of Psoriasis Patients' Adherence to Topical Drugs: Testing a Patient-supporting Intervention Delivered by Healthcare Professionals
- ClinicalTrials.gov ID
- NCT04220554
- Acronym / sponsor ID
- LF-OC-000048
- Conditions
- Psoriasis Vulgaris
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 103 participants (actual)
- Lead sponsor
- Odense University HospitalUniversity, hospital or other
- Study start
- 19 Jun 2020 (actual)
- Primary completion
- 16 Sep 2021 (actual)
- Study completion
- 1 Jun 2022 (actual)
- First posted
- 7 Jan 2020 (actual)
- Results
- Posted 30 Jan 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Psoriasis affects 2-4% of the Western adult population and is a socio-economic burden for patients and society. Topical drugs are recommended as first-line treatment for mild-to-moderate psoriasis, but low adherence is a barrier for treatment success. There is a need for improved patient support for psoriasis patients, which is suggested to improve long-term use of topical drugs.
The project aims to test whether a patient-supporting intervention delivered by healthcare professionals can improve the use of topical drugs. The intervention design is based on experiences with previous adherence-improving studies consisting of digital support by conducting a systematic literature search and holding focus groups with patients as well as healthcare professionals. The intervention consists of shared decision-making with patients, nurses and doctors, frequent consultations, easy access to healthcare professionals through video or in-office consultations and holding patients accountable for taking the medication.
The intervention will be tested in a randomized controlled trial: during a 48 week period, a group of patients (18-85 years of age) diagnosed with mild-to-moderate psoriasis and treated with topical drugs will be randomized to an intervention (n=40) or non-intervention group (n=40). The primary outcome will be severity of psoriasis and secondary outcomes primary adherence (i.e., rate of filled prescriptions) and quality of life.
If the intervention can reduce the severity of psoriasis in a significant manner, there is a potential for a national implementation of the intervention.
Detailed description
Background Psoriasis is a chronic inflammatory skin disease affecting 2-4% of the Western adult population. It is associated with many comorbidities, negatively affects quality of life and is a socioeconomic burden for patients and society. Topical drugs are the recommended first-line treatment for mild-to-moderate psoriasis, but adherence rates are low, which is a barrier for treatment success, resulting in a need for systemic or biological treatments, which are associated with more severe adverse events and are more expensive than topical drugs. However, improved adherence to topical drugs is associated with improved efficacy. That is why there is a need for improving psoriasis patients' adherence to topical drugs.
As a supplement to the introduction of new and advanced technology, there is a need for more studies on how to optimize the available healthcare professionals in dermatology clinics. Since dermatologists are a limited resource, there is a need to study how other healthcare professionals, e.g., hospital nurses and pharmaconomists at the pharmacies, can support psoriasis patients in their use of topical drugs.
Hypothesis
A patient-supporting intervention delivered by dermatologists, dermatology nurses and pharmaconomists significantly reduces psoriasis patients' severity of psoriasis compared to standard patient support.
Aims
The aim of the project is to test whether an individualized patient-supporting intervention delivered to psoriasis patients by dermatologists, nurses and pharmaconomists at a dermatology hospital clinic can: 1) reduce the severity of psoriasis, 2) improve quality of life, and 3) improve adherence to prescribed topical drugs.
Ethical considerations
All participants will be fully informed of the purpose of the study, and the study will be performed in accordance with the ethical principles in the Belmont report.
Materials and methods
The study is an investigator-initiated, single-centre, assessor-blinded, parallel group superiority randomized clinical study. Before inclusion of study participants, the study will be approved by the local regional ethics committee.
We will include patients (18-85 years of age) with milder-to-moderate psoriasis.
Outcomes
Outcome measurements will be either patient-reported or assessor-blinded.
Adherence measurements
Primary adherence: Proportion of filled topical prescriptions.
Secondary adherence:
Amount of medication used according to weight of the remains in the used medication packages. Data will be assessed week 48.
Disease severity measurements
Disease severity will be measured by Lattice-System Physician's Global Assessment (LS-PGA) (15), and the quality of life will be measured by the Dermatology Life Quality Index (DLQI). This data will be assessed at baseline, weeks 12, 24, 36 and 48.
Recruitment
Psoriasis patients who use topical treatments and are referred to the Department of Dermatology at Odense University Hospital will be recruited to the project until there is a sufficient number of participants included (n=100).
Hypothesis and expected number of participants
Our null hypothesis is that there is no difference in reduction of psoriasis between the intervention and non-intervention groups.
The sample size was calculated based on data from a previous project with consumption data for the use of prescribed calcipotriol betamethasone dipropionate cutaneous foam over 4 weeks. We expect an 20% difference in the LS-PGA, power 80%, two-sided significance of 95%, allocation of 1: 1 and an expected dropout rate of 25%. When using an unpaired t-test, the calculation resulted in the inclusion of a sample size consisting of 80 participants.
Blinding and randomization
Blinding of the data assessors: When the data assessor obtains baseline data from the study participants, it will be entered by an electronic data collection tool.
Participants will be allocated 1: 1 to an intervention or non-intervention arm via a computer-generated block randomization. The data assessor will be blinded to the allocation.
Statistics
Analysis of the primary outcome: changes in LS-PGA
Changes in LS-PGA measurements from baseline to weeks 12 and from baseline to weeks 24, 36 and 48 will be compared between the two groups by linear mixed model for longitudinal data. LS-PGA will be presented in box plots. As a sensitivity analysis on LS-PGA, the analysis will be carried out excluding missing data and after 100 times multiple imputations by multivariate normal regression on LS-PGA data, without included covariates in addition to with an imputation including treatment, age, sex and smoking as covariates.
Analysis of secondary outcomes: Changes in DLQI and adherence
Changes in DLQI measurements from baseline to weeks 12, 24, 36 and 48 will be compared between the two groups by linear mixed model for longitudinal data. DLQI will be presented in box plots.
For the analysis of adherence (by filled prescriptions, weight and patient reported), we will dichotomize adherence rate with a selected cut-off of 80%, with adherence rates above 80% considered adherent (a cut-off typically used when studying adherence in chronic diseases) [7, 42]. We will compare the dichotomized adherences by using logistic regression.
The statistical analysis will be conducted by an experienced statistician blinded to the intervention. An interim analysis is not planned.
Discussion
This study will demonstrate whether an individualized, optimized patient support delivered by doctors, nurses and pharmaconomists to dermatological patients can optimize the use of topical treatment, reduce the severity of psoriasis and have socioeconomic benefits compared to standard treatment. If the study shows that individualized and optimized patient support is effective, it is intended for the intervention to be implemented in the clinic. In addition, we will work on implementing the intervention nationally by a translational process.
Results from the study may also be referred to other chronic dermatological disorders. The study may be used methodically as a model for additional research projects investigating medical adherence in other chronic skin diseases.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention group | Experimental | Other: Improved support by health-care professionalsIntervention group: All participants will be instructed how to use of the medication according to "the fingertip unit for topical steroids". All participants will be prescribed topical drugs based on shared decision between the prescriber and patient. The topical drugs will be either moderate corticosteroids (clobetasone-17-butyrate or hydrocortisone-17-butyrate), potent corticosteroids (betamethasone-17-valerate and betamethasone, mometasone furoate, fluocinolone acetonide or fluocinonide), very potent corticosteroids (clobetasol propionate), corticosteroids with antimicrobials (betamethasone and clioquinol, betamethasone and fusidic acid or fluocinolone acetonide and clioquinol), corticosteroid with calcipotriol or calcipotriol cream. During the study period, a nurse or pharmaconomist will deliver; * Improved support and instructions to the patients * Patients will receive a diary and access to more consultations. |
| Non-intervention group | No intervention | –All participants will be instructed how to use of the medication according to "the fingertip unit for topical steroids". All participants will be prescribed topical drugs based on shared decision between the prescriber and patient. The topical drugs will be either moderate corticosteroids (clobetasone-17-butyrate or hydrocortisone-17-butyrate), potent corticosteroids (betamethasone-17-valerate and betamethasone, mometasone furoate, fluocinolone acetonide or fluocinonide), very potent corticosteroids (clobetasol propionate), corticosteroids with antimicrobials (betamethasone and clioquinol, betamethasone and fusidic acid or fluocinolone acetonide and clioquinol), corticosteroid with calcipotriol or calcipotriol cream. |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
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 |
|---|---|---|
| Improved support by health-care professionalsImproved support to patients prescribed topical antipsoriatic drugs | Other | Intervention group |
Primary outcome
Severity of Psoriasis
Time frame: Change from baseline at week 48
Lattice-System Physician's Global Assessment (LS-PGA) (interval scale). From value 1 (no visible psoriasis) to 8 (severely affected by psoriasis).
2 secondary outcomes
Secondary Adherence
Time frame: Week 48
Quality of Life (QOL)
Time frame: Change from baseline to week 48
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jan 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 34696820Svendsen MT, Feldman SR, Moller S, Kongstad LP, Andersen KE. Long-term improvement of psoriasis patients' adherence to topical drugs: testing a patient-supporting intervention delivered by healthcare professionals. Trials. 2021 Oct 25;22(1):742. doi: 10.1186/s13063-021-05707-6.
- Results publication: PubMed 35973788Svendsen MT, Feldman SR, Mejldal A, Moller S, Kongstad LP, Andersen KE. Regular support provided by dermatological nurses improves outcomes in patients with psoriasis treated with topical drugs: a randomized controlled trial. Clin Exp Dermatol. 2022 Dec;47(12):2208-2221. doi: 10.1111/ced.15370. Epub 2022 Oct 25.
- Results publication: PubMed 37585448Svendsen MT, Andersen KE, Feldman SR, Mejldal A, Moller S, Kongstad LP. An effective patient-supporting intervention for topical treatment of psoriasis is also cost-effective. Clin Exp Dermatol. 2023 Oct 25;48(11):1247-1254. doi: 10.1093/ced/llad272.
- Individual participant dataSharing planned: No
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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.
Mathias T Svendsen, MD, PhD principal investigator
Odense University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Improved support by health-care professionals in people with Psoriasis Vulgaris, run by Odense University Hospital at 1 site in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
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: finished, as of the sponsor's last update on 30 Jan 2024. 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 Denmark. 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?
Yes. Results are posted in the registry (first posted 30 Jan 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Severity of Psoriasis (time frame: Change from baseline at week 48). 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 NCT04220554, which also lists 3 linked publications.
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 30 Jan 2024.