PsoriasisNCT03483311
Resolvin D1 in Psoriasis Before and After Narrowband UVB Phototherapy
A study testing skin biopsy before and after NB-UVB phototherapy in people with Psoriasis, run by Cairo University at 1 site in Egypt.
Trial summary
Assessment of tissue level of resolvin D1 in psoriasis in comparison to its level in healthy controls in order to verify its role in the pathogenesis of psoriasis. Read more about this study
- Who is it for?
- Ages 12 years and olderHealthy volunteers can take part
- Conditions the study is for
- Psoriasis
- What is being tested?
- skin biopsy before and after NB-UVB phototherapy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Mar 2018to Sep 2018
- 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 12 years and older
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Patients with psoriasis (adults and children above 12years)
- Both sexes.
- New cases or cases not receiving any treatment for at least 3 months ago.
Who cannot join
- Any contraindication to phototherapy treatment (e.g. Photosensitizing creams or medications, past skin cancer, especially melanoma, etc...)
- Erythrodermic and pustular psoriasis.
- History of autoimmune diseases or other systemic diseases (e.g. Alzheimer's disease, fibromyalgia, cystic fibrosis)
Trial locations and contacts
1 site in 1 country.
Egypt1 site, 1 recruiting
- Recruiting
Maha Fathy Elmasry
Cairo, 11562
Maha Fathy Elmasry, MD, 01222633740, mahafathy1214@gmail.com
About this study
Official title: Estimation of Tissue Level of Resolvin D1 in Psoriasis Before and After Narrowband UVB Phototherapy: a Case-control Study.
- Assessment of tissue level of resolvin D1 in psoriasis in comparison to its level in healthy controls in order to verify its role in the pathogenesis of psoriasis.
- Conditions
- Psoriasis
- Being tested
- skin biopsy before and after NB-UVB phototherapy
- Medical subject headings
- Psoriasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
skin biopsy before and after NB-UVB phototherapyOther
skin biopsy before and after NB-UVB phototherapy to measure tissue resolvin D1
| Study group | Role | What they receive |
|---|---|---|
| psoriasis patients | Experimental | Tissue levels of resolvin D1 in psoriatic patients before and after NB-UVB. Receives: Other: skin biopsy before and after NB-UVB phototherapy |
| controls | Experimental | Tissue levels of resolvin D1 in controls Receives: Other: skin biopsy before and after NB-UVB phototherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Tissue levels of resolvin D1 in psoriatic patients before and after NB-UVB.
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 posted30 Mar 2018
- Study start1 Mar 2018
- Primary completionSep 2018 (estimated)
- Study completionSep 2018 (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 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
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Maha Fathy Elmasry, Cairo University
- Investigators
- Maha Elmasry, Principal investigator, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03483311
- Sponsor's protocol ID
- Dermatology7
- Status last verified
- Mar 2018
- First submitted
- 23 Mar 2018
- Last updated
- 30 Mar 2018
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Elmasry MF, Hassan E, Rashed LA, Abdel Halim DM. Role of resolvin D1 in psoriasis before and after narrowband ultraviolet B phototherapy: A case-control study. Dermatol Ther. 2021 Mar;34(2):e14879. doi: 10.1111/dth.14879. Epub 2021 Feb 21.
PubMed 33586174
Study at a glance
From the registry record, last updated by the sponsor on 30 Mar 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Estimation of Tissue Level of Resolvin D1 in Psoriasis Before and After Narrowband UVB Phototherapy: a Case-control Study.
- ClinicalTrials.gov ID
- NCT03483311
- Acronym / sponsor ID
- Dermatology7
- Conditions
- Psoriasis
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 1 Mar 2018 (actual)
- Primary completion
- Sep 2018 (estimated)
- Study completion
- Sep 2018 (estimated)
- First posted
- 30 Mar 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.
- Assessment of tissue level of resolvin D1 in psoriasis in comparison to its level in healthy controls in order to verify its role in the pathogenesis of psoriasis.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| psoriasis patients | Experimental | Other: skin biopsy before and after NB-UVB phototherapyTissue levels of resolvin D1 in psoriatic patients before and after NB-UVB. |
| controls | Experimental | Other: skin biopsy before and after NB-UVB phototherapyTissue levels of resolvin D1 in controls |
Who may qualify
- Ages
- 12 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- Patients with psoriasis (adults and children above 12years)
- Both sexes.
- New cases or cases not receiving any treatment for at least 3 months ago.
Key exclusion criteria (3 listed)
- Any contraindication to phototherapy treatment (e.g. Photosensitizing creams or medications, past skin cancer, especially melanoma, etc...)
- Erythrodermic and pustular psoriasis.
- History of autoimmune diseases or other systemic diseases (e.g. Alzheimer's disease, fibromyalgia, cystic fibrosis)
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 |
|---|---|---|
| skin biopsy before and after NB-UVB phototherapyskin biopsy before and after NB-UVB phototherapy to measure tissue resolvin D1 | Other | controls, psoriasis patients |
Primary outcome
Tissue levels of resolvin D1 in psoriatic patients before and after NB-UVB.
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 30 Mar 2018.
- Derived from this study: PubMed 33586174Elmasry MF, Hassan E, Rashed LA, Abdel Halim DM. Role of resolvin D1 in psoriasis before and after narrowband ultraviolet B phototherapy: A case-control study. Dermatol Ther. 2021 Mar;34(2):e14879. doi: 10.1111/dth.14879. Epub 2021 Feb 21.
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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.
Maha Elmasry principal investigator
Cairo University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing skin biopsy before and after NB-UVB phototherapy in people with Psoriasis, run by Cairo University 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 3 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 30 Mar 2018. 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.
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 Maha Fathy Elmasry, MD (01222633740, mahafathy1214@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Tissue levels of resolvin D1 in psoriatic patients before and after 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?
On the ClinicalTrials.gov record for NCT03483311, 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 30 Mar 2018.