PsoriasisPhase 4NCT04811911
Evaluation of the Effect of Narrowband UVB Versus Methotrexate on Serum TWEAK Level in Psoriasis
A Phase 4 study testing Narrowband ultraviolet B and Methotrexate in people with Psoriasis, run by Aswan University Hospital at 1 site in Egypt.
Trial summary
The aim of the study is to evaluate the effect of NB-UVB versus MTX on serum TWEAK level in psoriatic patients. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Psoriasis
- What is being tested?
- Narrowband ultraviolet B and Methotrexate
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteEgypt
- Study dates
- 13 Dec 2020to 15 Dec 2021
- 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
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Patients with moderate to severe plaque psoriasis of any age and gender.
Who cannot join
- History of psoriasis treatment with systemic and biological agents prior to the study for at least 3 months.
- Pregnancy and lactation.
- Infections
- Patients with chronic diseases: hepatic disorders, hematologic disease, chronic renal failure or cancer
Trial locations and contacts
1 site in 1 country.
Egypt1 site
Aswan University - Faculty of Medicine
Aswān, Aswan Governorate, 81528
About this study
Official title: Evaluation of the Effect of Narrowband Ultraviolet B Versus Methotrexate on Serum TWEAK Level in Psoriasis
The aim of the study is to evaluate the effect of NB-UVB versus MTX on serum TWEAK level in psoriatic patients.
- Conditions
- Psoriasis
- Being tested
- Narrowband ultraviolet B, Methotrexate
- Medical subject headings
- Psoriasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Narrowband ultraviolet BRadiation
Also called NB-UVB
Patients will receive 8 sessions of NB-UVB per month for 3 successive months
MethotrexateDrug
Also called MTX
Patients will receive 25 mg/1ml of methotrexate vial per week for 3 successive months
| Study group | Role | What they receive |
|---|---|---|
| Narrowband ultraviolet B | Active comparator | Patients will receive 8 sessions of NB-UVB per month for 3 successive months Receives: Radiation: Narrowband ultraviolet B |
| Methotrexate group | Active comparator | Patients will receive 25 mg/1ml of methotrexate vial per week for 3 successive months Receives: Drug: Methotrexate |
| healthy individuals as control group | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Serum TWEAK in psoriasis
Measurement of tumor necrosis factor weak inducer of apoptosis (TWEAK) "pg/ml"; in psoriatic patients before and after treatment with NB-UVB versus MTX in comparison with healthy individuals, using ELISA (enzyme-linked immunosorbent assay).
Measured: 3 months
Secondary outcomes (1)
Treatment of psoriasis
Clinical evaluation: Assessment of disease severity will be performed by using psoriasis area severity index (PASI score) before and after treatment with NB-UVB in comparison with MTX. Patients will be photographed at baseline and after 3 months of regular treatment by using high resolution digital camera canon EOS 1300D 18 megapixels (made in taiwan), photography will be done in standard light and distance.
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Mar 2021
- Study start13 Dec 2020
- Primary completion15 Sep 2021 (estimated)
- Study completion15 Dec 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PsoriasisStudies 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
- Randomised
- Intervention model
- Factorial
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Aswan University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, El Hassan Mohsen Mansour Mahmoud, Aswan University Hospital
- Investigators
- Moustafa A El Taieb, Professor, Study chair, Faculty of medicine aswan university
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04811911
- Sponsor's protocol ID
- 498/12/20
- Status last verified
- Mar 2021
- First submitted
- 5 Mar 2021
- Last updated
- 23 Mar 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Effect of Narrowband Ultraviolet B Versus Methotrexate on Serum TWEAK Level in Psoriasis
- ClinicalTrials.gov ID
- NCT04811911
- Acronym / sponsor ID
- 498/12/20
- Conditions
- Psoriasis
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Aswan University HospitalUniversity, hospital or other
- Study start
- 13 Dec 2020 (actual)
- Primary completion
- 15 Sep 2021 (estimated)
- Study completion
- 15 Dec 2021 (estimated)
- First posted
- 23 Mar 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 aim of the study is to evaluate the effect of NB-UVB versus MTX on serum TWEAK level in psoriatic patients.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Narrowband ultraviolet B | Active comparator | Radiation: Narrowband ultraviolet BPatients will receive 8 sessions of NB-UVB per month for 3 successive months |
| Methotrexate group | Active comparator | Drug: MethotrexatePatients will receive 25 mg/1ml of methotrexate vial per week for 3 successive months |
| healthy individuals as control group | No intervention | – |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- Patients with moderate to severe plaque psoriasis of any age and gender.
Key exclusion criteria (4 listed)
- History of psoriasis treatment with systemic and biological agents prior to the study for at least 3 months.
- Pregnancy and lactation.
- Infections
- Patients with chronic diseases: hepatic disorders, hematologic disease, chronic renal failure or cancer
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 |
|---|---|---|
| Narrowband ultraviolet BAlso: NB-UVBPatients will receive 8 sessions of NB-UVB per month for 3 successive months | Radiation | Narrowband ultraviolet B |
| MethotrexateAlso: MTXPatients will receive 25 mg/1ml of methotrexate vial per week for 3 successive months | Drug | Methotrexate group |
Primary outcome
Serum TWEAK in psoriasis
Time frame: 3 months
Measurement of tumor necrosis factor weak inducer of apoptosis (TWEAK) "pg/ml"; in psoriatic patients before and after treatment with NB-UVB versus MTX in comparison with healthy individuals, using ELISA (enzyme-linked immunosorbent assay).
1 secondary outcome
Treatment of psoriasis
Time frame: 3 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Mar 2021.
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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.
Moustafa A El Taieb, Professor study chair
Faculty of medicine aswan university
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 Narrowband ultraviolet B and Methotrexate in people with Psoriasis, run by Aswan University Hospital at 1 site in Egypt.
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 1 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 23 Mar 2021. 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 Egypt. 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?
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?
Serum TWEAK in psoriasis (time frame: 3 months). 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 23 Mar 2021.