PsoriasisNCT03526705
The Effect of NB-UVB on Interleukin-36 Levels in Psoriasis
A study testing NB-UVB in people with Psoriasis, run by Cairo University.
Trial summary
Psoriasis is an immune-mediated skin disease that affects 1-2 % of the population. Several cytokines have been found to be involved in the complex pathogenesis of this disease. Il- 36 is one of the cytokines sharing in psoriasis pathogenesis, as its levels are elevated in psoriatic plaques. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Psoriasis
- What is being tested?
- NB-UVB
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 25 participants
- Where
- No sites listed yet
- Study dates
- 15 Jul 2019to 15 Jan 2020
- Phase
- Interventional
- 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 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Patients with psoriasis vulgaris of both sexes
- Age between 18 and 60 years old.
Who cannot join
- Pregnant females
- Patients receiving systemic treatment or topical treatment for psoriasis within the past two months.
- Patients having other dermatological diseases.
About this study
Official title: The Effect of NB-UVB on Interleukin-36 Levels in Psoriasis Lesional Skin
Psoriasis is an immune-mediated skin disease that affects 1-2 % of the population. Several cytokines have been found to be involved in the complex pathogenesis of this disease. Il- 36 is one of the cytokines sharing in psoriasis pathogenesis, as its levels are elevated in psoriatic plaques. Cathepsin G is known to activate Il- 36 and promote inflammation in psoriasis.NB-UVB is one of the important treatment modalities for psoriasis.
The aim of this study is to detect the effect of NB-UVB on the lesional levels of IL-36 in psoriasis.
Read the detailed description
25 psoriasis patients will receive 26 sessions of phototherapy (NB-UVB). Patients will receive 3 sessions per week. Tissue levels of IL-36 and Cathepsin G will be assessed in skin lesions before starting treatment and after completing the 26 sessions.
- Conditions
- Psoriasis
- Being tested
- NB-UVB
- Medical subject headings
- Psoriasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NB-UVBDevice
Phototherapy
| Study group | Role | What they receive |
|---|---|---|
| nb-uvb | Experimental | psoriasis patients will receive 26 sessions of nb-uvb phototherapy Receives: Device: NB-UVB |
What is being measured
The primary outcome is the main question the study is designed to answer.
changes in Il-36 levels in 25 psoriasis patients after 26 sessions of NB-UVB
primary
Measured: 6 months
Secondary outcomes (1)
changes in cathepsin G levels in 25 psoriasis patients after 26 sessions of NB-UVB psoriasis
secondary
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 May 2018
- Study start15 Jul 2019 (estimated)
- Primary completion15 Jan 2020 (estimated)
- Study completion15 Jan 2020 (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.
- More trials run by Cairo UniversityThe 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
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 25 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dina Saadi, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03526705
- Sponsor's protocol ID
- Kapu1
- Status last verified
- Jul 2019
- First submitted
- 4 May 2018
- Last updated
- 23 Jul 2019
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Jul 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of NB-UVB on Interleukin-36 Levels in Psoriasis Lesional Skin
- ClinicalTrials.gov ID
- NCT03526705
- Acronym / sponsor ID
- Kapu1
- Conditions
- Psoriasis
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 25 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 15 Jul 2019 (estimated)
- Primary completion
- 15 Jan 2020 (estimated)
- Study completion
- 15 Jan 2020 (estimated)
- First posted
- 16 May 2018 (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.
Psoriasis is an immune-mediated skin disease that affects 1-2 % of the population. Several cytokines have been found to be involved in the complex pathogenesis of this disease. Il- 36 is one of the cytokines sharing in psoriasis pathogenesis, as its levels are elevated in psoriatic plaques. Cathepsin G is known to activate Il- 36 and promote inflammation in psoriasis.NB-UVB is one of the important treatment modalities for psoriasis.
The aim of this study is to detect the effect of NB-UVB on the lesional levels of IL-36 in psoriasis.
Detailed description
25 psoriasis patients will receive 26 sessions of phototherapy (NB-UVB). Patients will receive 3 sessions per week. Tissue levels of IL-36 and Cathepsin G will be assessed in skin lesions before starting treatment and after completing the 26 sessions.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| nb-uvb | Experimental | Device: NB-UVBpsoriasis patients will receive 26 sessions of nb-uvb phototherapy |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Patients with psoriasis vulgaris of both sexes
- Age between 18 and 60 years old.
Key exclusion criteria (3 listed)
- Pregnant females
- Patients receiving systemic treatment or topical treatment for psoriasis within the past two months.
- Patients having other dermatological diseases.
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 |
|---|---|---|
| NB-UVBPhototherapy | Device | nb-uvb |
Primary outcome
changes in Il-36 levels in 25 psoriasis patients after 26 sessions of NB-UVB
Time frame: 6 months
primary
1 secondary outcome
changes in cathepsin G levels in 25 psoriasis patients after 26 sessions of NB-UVB psoriasis
Time frame: 6 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jul 2019.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing NB-UVB in people with Psoriasis, run by Cairo University.
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 2 inclusion and 3 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 Jul 2019. Status can change between updates, so confirm with the study contact before making plans.
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?
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?
changes in Il-36 levels in 25 psoriasis patients after 26 sessions of NB-UVB (time frame: 6 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 Jul 2019.