Psoriasis VulgarisEarly Phase 1NCT03874975
Combined Oral Vitamin D and UVB Versus UVB Alone in Treatment of Psoriasis Vulgaris
A Early Phase 1 study testing oral vitamin D in people with Psoriasis Vulgaris, run by Assiut University.
Trial summary
To compare the results of vitamin D plus UVB in treatment of psoriasis vulgaris with the results of UVB alone to study the relation between serum vitamin D and PASI score before and after treatment. Read more about this study
- Who is it for?
- Ages 10 to 60 years
- Conditions the study is for
- Psoriasis Vulgaris
- What is being tested?
- oral vitamin D
- Type of treatment
- Pill or oral medicine
- How many people
- 40 participants
- Where
- No sites listed yet
- Study dates
- 1 Apr 2019to 1 Apr 2020
- Phase
- Early Phase 1
- 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 10 to 60 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- : patients from 10 to 60 diagnosed to have psoriasis vulgaris
Who cannot join
- concomitant chronic inflammatory disease or malignancy.
- pregnant and lactating women.
- renal dysfunction.
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Combined Oral Vitamin D and UVB Versus Alone in Treatment of Psoroasis Vulgaris
To compare the results of vitamin D plus UVB in treatment of psoriasis vulgaris with the results of UVB alone to study the relation between serum vitamin D and PASI score before and after treatment.
Read the detailed description
Psoriasis is a chronic immune-mediated inflammatory skin disease, with a prevalence of about 2%-3% in the general population. The primary manifestation of psoriasis most commonly manifests on the skin, although inflammatory processes can occur also in other organs .
Vitamin D, also known as the sunshine vitamin, has long been known to be a hormone that regulates calcium-phosphorous homeostasis and safeguards the integrity of the skeletal system . The epidermis is the natural source of vitamin D synthesis by the action of ultraviolet light (UV) B of the sun or other UVB source . On the other hand, evidence is accumulating that vitamin D might represent a key modulator of immune and inflammation mechanisms . Recently, a role for vitamin D in the pathogenesis of different skin diseases, including psoriasis, has been reported.
Psoriasis lesions are characterized by hyper-proliferation with incomplete differentiation of epidermal keratinocytes and decreased keratinocyte apoptosis, associated with inflammatory cellular infiltrate in both dermis and epidermis . Psoriasis Area and Severity Index (PASI) score is currently the preferred method for the assessment of the disease severity and extent .
Physiologically, the active form of vitamin D and its receptor regulate the differentiation and proliferation of keratinocytes, the balance of the cutaneous immune system and the process of apoptosis.
Several studies identified an association between polymorphisms of vitamin D receptor (VDR) and psoriasis susceptibility .The 1,25(OH)D has been shown to exert anti-proliferative effects on keratinocytes .
The exact mechanism of action of NBUVB is not known. It is proposed that it acts in the following ways: (1) Cellular DNA is converted to pyrimidine dimers which interfere with cell cycle progression, (2) alteration in cytokine production, NBUVB phototherapy as the second-line treatment for psoriasis, recommended when the topical therapy fails, is contraindicated or impractical. UVB radia- tions of wavelength 311 nm may result in the clearance of disease symptoms after just 5-8 weeks.
- Conditions
- Psoriasis Vulgaris
- Being tested
- oral vitamin D
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
oral vitamin DDrug
Also called narrow band UVB
vitamin D and UVB versus UVB alone in psoriatic patients and evaluate patients by PASI score before and after treatment and measure serum vitamin D before and after treatment
What is being measured
The primary outcome is the main question the study is designed to answer.
measure serum vitamin D before and after treatment in psoriatic patients
A 3ml blood sample will be collected from the patients, then allowed to clot for 10 minutes and then centrifuged .
Group 1: 20 patients under oral vitamin D therapy ( oral alpha one for 3 months o.25 microgram / day ) in combination with narrow band UVB settings (twice/week) Group 2 : 20 patients under narrow band UVB therapy only . c) We evaluate psoriatic patient by PASI score before and after treatment :
) measurment vitamin D level before and after treatment.
Measured: 1 year
Secondary outcomes (1)
We evaluate psoriatic patient by PASI score before and after treatment :
The body is divided into four sections (head (H) (10% of a person's skin); arms (A) (20%); trunk (T) (30%); legs (L) (40%)).
Each of these areas is scored by itself, and then the four scores are combined into the final PASI. For each section, the percent of area of skin involved, is estimated and then transformed into a grade from 0 to 6:
0.0% of involved area
1.< 10% of involved area 2.10-29% of involved area 3.30-49% of involved area 4.50-69% of involved area 5.70-89% of involved area 6.90-100% of involved area
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Mar 2019
- Study start1 Apr 2019 (estimated)
- Primary completion1 Apr 2019 (estimated)
- Study completion1 Apr 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Psoriasis VulgarisStudies of the same condition, open and under way.
- More trials run by Assiut 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
- Early Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Model description
- 40 patients divided into two groups : group 1 :20 patients underoral vitamin D and UVB group 2 : 20 patients under uvb alone in psoriatic patients
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Meryhan Ashraf Abdelazeem, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03874975
- Sponsor's protocol ID
- vit D and UVB in psoriasis
- Status last verified
- Mar 2019
- First submitted
- 6 Mar 2019
- Last updated
- 14 Mar 2019
- 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 14 Mar 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Combined Oral Vitamin D and UVB Versus Alone in Treatment of Psoroasis Vulgaris
- ClinicalTrials.gov ID
- NCT03874975
- Acronym / sponsor ID
- vit D and UVB in psoriasis
- Conditions
- Psoriasis Vulgaris
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 1 Apr 2019 (estimated)
- Primary completion
- 1 Apr 2019 (estimated)
- Study completion
- 1 Apr 2020 (estimated)
- First posted
- 14 Mar 2019 (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.
To compare the results of vitamin D plus UVB in treatment of psoriasis vulgaris with the results of UVB alone to study the relation between serum vitamin D and PASI score before and after treatment.
Detailed description
Psoriasis is a chronic immune-mediated inflammatory skin disease, with a prevalence of about 2%-3% in the general population. The primary manifestation of psoriasis most commonly manifests on the skin, although inflammatory processes can occur also in other organs .
Vitamin D, also known as the sunshine vitamin, has long been known to be a hormone that regulates calcium-phosphorous homeostasis and safeguards the integrity of the skeletal system . The epidermis is the natural source of vitamin D synthesis by the action of ultraviolet light (UV) B of the sun or other UVB source . On the other hand, evidence is accumulating that vitamin D might represent a key modulator of immune and inflammation mechanisms . Recently, a role for vitamin D in the pathogenesis of different skin diseases, including psoriasis, has been reported.
Psoriasis lesions are characterized by hyper-proliferation with incomplete differentiation of epidermal keratinocytes and decreased keratinocyte apoptosis, associated with inflammatory cellular infiltrate in both dermis and epidermis . Psoriasis Area and Severity Index (PASI) score is currently the preferred method for the assessment of the disease severity and extent .
Physiologically, the active form of vitamin D and its receptor regulate the differentiation and proliferation of keratinocytes, the balance of the cutaneous immune system and the process of apoptosis.
Several studies identified an association between polymorphisms of vitamin D receptor (VDR) and psoriasis susceptibility .The 1,25(OH)D has been shown to exert anti-proliferative effects on keratinocytes .
The exact mechanism of action of NBUVB is not known. It is proposed that it acts in the following ways: (1) Cellular DNA is converted to pyrimidine dimers which interfere with cell cycle progression, (2) alteration in cytokine production, NBUVB phototherapy as the second-line treatment for psoriasis, recommended when the topical therapy fails, is contraindicated or impractical. UVB radia- tions of wavelength 311 nm may result in the clearance of disease symptoms after just 5-8 weeks.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Single blind (participant)
- Model description
- 40 patients divided into two groups : group 1 :20 patients underoral vitamin D and UVB group 2 : 20 patients under uvb alone in psoriatic patients
Who may qualify
- Ages
- 10 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (1 listed)
- : patients from 10 to 60 diagnosed to have psoriasis vulgaris
Key exclusion criteria (3 listed)
- concomitant chronic inflammatory disease or malignancy.
- pregnant and lactating women.
- renal dysfunction.
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 |
|---|---|---|
| oral vitamin DAlso: narrow band UVBvitamin D and UVB versus UVB alone in psoriatic patients and evaluate patients by PASI score before and after treatment and measure serum vitamin D before and after treatment | Drug | – |
Primary outcome
measure serum vitamin D before and after treatment in psoriatic patients
Time frame: 1 year
A 3ml blood sample will be collected from the patients, then allowed to clot for 10 minutes and then centrifuged . Group 1: 20 patients under oral vitamin D therapy ( oral alpha one for 3 months o.25 microgram / day ) in combination with narrow band UVB settings (twice/week) Group 2 : 20 patients under narrow band UVB therapy only . c) We evaluate psoriatic patient by PASI score before and after treatment : ) measurment vitamin D level before and after treatment.
1 secondary outcome
We evaluate psoriatic patient by PASI score before and after treatment :
Time frame: 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Mar 2019.
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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.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing oral vitamin D in people with Psoriasis Vulgaris, run by Assiut 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 1 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 14 Mar 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.
What does this phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
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?
Contact meryhan abdelazeem, master (01204425625, ashrafmeryhan7@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
measure serum vitamin D before and after treatment in psoriatic patients (time frame: 1 year). 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 14 Mar 2019.