Psoriasis VulgarisPhase 1NCT05184348
Plexin B2 Gene Expression and Polymorphisms in Psoriasis
A Phase 1 study testing Narrow band Ultraviolet B phototherapy group, Acitretin group and Acitretin plus Narrow band Ultraviolet B phototherapy group in people with Psoriasis Vulgaris, run by South Valley University at 1 site in Egypt.
Trial summary
Patients will be randomly assigned (1:1:1 ) either to ; NB-UVB photo-therapy alone , Acitretin therapy alone or NB-UVB photo-therapy combined with Acitretin therapy randomization will be done by closed envelopes . Read more about this study
- Who is it for?
- Ages 24 to 64 yearsHealthy volunteers can take part
- Conditions the study is for
- Psoriasis Vulgaris
- What is being tested?
- Narrow band Ultraviolet B phototherapy group, Acitretin group and Acitretin plus Narrow band Ultraviolet B phototherapy group
- Type of treatment
- Pill or oral medicine, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Sep 2021to 30 Mar 2023
- Phase
- 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 24 to 64 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Patients of both sexes. Diagnosed clinically with moderate to severe Psoriasis Vulgaris.
- patients able to swallow tablet and receive Narrow band Ultraviolet B phototherapy without any contraindication
Who cannot join
- Pregnancy , lactation \& women intent to become pregnant within 3 year after discontinuation of acitretin Patients with Hyperlipidemia Patients with mental problems and depression Patients with a history of malignancies, renal \& liver diseases. Patients with a history of any inflammatory diseases as atopic dermatitis , asthma ulcerative colitis ) and Crohn's disease Patients received NB-UVB phototherapy in the last 6 months. Patients treated with methotrexate or biologic agents and any systemic treatment of psoriasis.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Plexin B2 Gene Expression and Polymorphisms in Psoriasis : Relation to NB-UVB, Acitretin and Combined Therapy
Patients will be randomly assigned (1:1:1 ) either to ; NB-UVB photo-therapy alone , Acitretin therapy alone or NB-UVB photo-therapy combined with Acitretin therapy randomization will be done by closed envelopes . investigator will be blinded to study drug assignment , while patients and data interpreter will not be masked to study drug assignment.
Read the detailed description
Study Setting: Qena University Hospital, Department of Dermatology ,Venereology\& Andrology.
Study subjects: the study will include psoriasis Vulgaris patients who Come to the out patients dermatologic clinic and matching inclusion \& exclusion criteria as follow, from 9/2021 up to 3/2023 and then patients will be divided to each group equally as follow:
Group 1: Patients will be treated with NB-UVB phototherapy 3 sessions weekly for 3 months with maximum dose of 1400 mJ/cm2.
Group 2: Patients will be treated with Acitretin in dose of 0.5-1 mg per kg per day orally for 3 months Group 3: Patients will be treated with Acitretin in dose of 0.5-1 mg per kg per day orally plus NB-UVB phototherapy 3 sessions weekly for 3 months with maximum dose 1400 mJ/cm2.
Group 4: 30 healthy individuals un related , age, sex , BMI matched with volunteers.
- Conditions
- Psoriasis Vulgaris
- Being tested
- Narrow band Ultraviolet B phototherapy group, Acitretin group, Acitretin plus Narrow band Ultraviolet B phototherapy group
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Narrow band Ultraviolet B phototherapy groupRadiation
Also called NB-UVB
3 sessions weekly for 3 months with maximum dose 1400 mJ/cm2.
Acitretin groupDrug
dose of 0.5-1 mg per kg per day orally for 3 month.
Acitretin plus Narrow band Ultraviolet B phototherapy groupCombination product
Acitretin in dose of 0.5-1 mg per kg per day orally plus Narrow band Ultraviolet B phototherapy 3 sessions weekly for 3 months with maximum dose 1400 mJ/cm2.
| Study group | Role | What they receive |
|---|---|---|
| Narrow band Ultraviolet B phototherapy group | Active comparator | Patients will be treated with Narrow band Ultraviolet B phototherapy 3 sessions weekly for 3 months with maximum dose of 1400 mJ/cm2. Receives: Radiation: Narrow band Ultraviolet B phototherapy group |
| Acitretin group | Active comparator | Patients will be treated with Acitretin in dose of 0.5-1 mg per kg per day orally for 3 months Receives: Drug: Acitretin group |
| Acitretin plus Narrow band Ultraviolet B phototherapy group | Active comparator | Patients will be treated with Acitretin in dose of 0.5-1 mg per kg per day orally plus NB-UVB phototherapy 3 sessions weekly for 3 months with maximum dose 1400 mJ/cm2. Receives: Combination Product: Acitretin plus Narrow band Ultraviolet B phototherapy group |
| Control group | No intervention | 30 healthy individuals un related , age, sex , BMI matched with volunteers. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Improve the prognosis of patients with psoriasis Vulgaris
detect the effect of Acitretin alone and Narrow band Ultraviolet B phototherapy alone versus combined therapy on genetic mutation and level of plexin b2 in patients with psoriasis Vulgaris
Measured: 3 month
Secondary outcomes (1)
Improve the clinical out comes of patients with psoriasis Vulgaris
detect the effect of Acitretin alone and Narrow band Ultraviolet B phototherapy alone versus combined therapy on clinical out comes and PASI score of patients with psoriasis Vulgaris
Measured: 12 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jan 2022
- Study start1 Sep 2021
- Primary completion30 Jan 2023
- Study completion30 Mar 2023
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.
- 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 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 200 participants (actual)
Sponsor and investigators
- Lead sponsor
- South Valley University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ebtehal alaa el Dean kotop Mohamed, MD, South Valley University
- Investigators
- Eisa Hegazy, Prof., Study chair, Faculty of Medicine, South Valley University, Egypt
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05184348
- Sponsor's protocol ID
- Ebtehal Mohamed
- Status last verified
- Sep 2023
- First submitted
- 23 Nov 2021
- Last updated
- 21 Sep 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Plexin B2 Gene Expression and Polymorphisms in Psoriasis : Relation to NB-UVB, Acitretin and Combined Therapy
- ClinicalTrials.gov ID
- NCT05184348
- Acronym / sponsor ID
- Ebtehal Mohamed
- Conditions
- Psoriasis Vulgaris
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 200 participants (actual)
- Lead sponsor
- South Valley UniversityUniversity, hospital or other
- Study start
- 1 Sep 2021 (actual)
- Primary completion
- 30 Jan 2023 (actual)
- Study completion
- 30 Mar 2023 (actual)
- First posted
- 11 Jan 2022 (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.
Patients will be randomly assigned (1:1:1 ) either to ; NB-UVB photo-therapy alone , Acitretin therapy alone or NB-UVB photo-therapy combined with Acitretin therapy randomization will be done by closed envelopes . investigator will be blinded to study drug assignment , while patients and data interpreter will not be masked to study drug assignment.
Detailed description
Study Setting: Qena University Hospital, Department of Dermatology ,Venereology\& Andrology.
Study subjects: the study will include psoriasis Vulgaris patients who Come to the out patients dermatologic clinic and matching inclusion \& exclusion criteria as follow, from 9/2021 up to 3/2023 and then patients will be divided to each group equally as follow:
Group 1: Patients will be treated with NB-UVB phototherapy 3 sessions weekly for 3 months with maximum dose of 1400 mJ/cm2.
Group 2: Patients will be treated with Acitretin in dose of 0.5-1 mg per kg per day orally for 3 months Group 3: Patients will be treated with Acitretin in dose of 0.5-1 mg per kg per day orally plus NB-UVB phototherapy 3 sessions weekly for 3 months with maximum dose 1400 mJ/cm2.
Group 4: 30 healthy individuals un related , age, sex , BMI matched with volunteers.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Narrow band Ultraviolet B phototherapy group | Active comparator | Radiation: Narrow band Ultraviolet B phototherapy groupPatients will be treated with Narrow band Ultraviolet B phototherapy 3 sessions weekly for 3 months with maximum dose of 1400 mJ/cm2. |
| Acitretin group | Active comparator | Drug: Acitretin groupPatients will be treated with Acitretin in dose of 0.5-1 mg per kg per day orally for 3 months |
| Acitretin plus Narrow band Ultraviolet B phototherapy group | Active comparator | Combination Product: Acitretin plus Narrow band Ultraviolet B phototherapy groupPatients will be treated with Acitretin in dose of 0.5-1 mg per kg per day orally plus NB-UVB phototherapy 3 sessions weekly for 3 months with maximum dose 1400 mJ/cm2. |
| Control group | No intervention | –30 healthy individuals un related , age, sex , BMI matched with volunteers. |
Who may qualify
- Ages
- 24 to 64 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Patients of both sexes. Diagnosed clinically with moderate to severe Psoriasis Vulgaris.
- patients able to swallow tablet and receive Narrow band Ultraviolet B phototherapy without any contraindication
Key exclusion criteria (1 listed)
- Pregnancy , lactation \& women intent to become pregnant within 3 year after discontinuation of acitretin Patients with Hyperlipidemia Patients with mental problems and depression Patients with a history of malignancies, renal \& liver diseases. Patients with a history of any inflammatory diseases as atopic dermatitis , asthma ulcerative colitis ) and Crohn's disease Patients received NB-UVB phototherapy in the last 6 months. Patients treated with methotrexate or biologic agents and any systemic treatment of psoriasis.
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 |
|---|---|---|
| Narrow band Ultraviolet B phototherapy groupAlso: NB-UVB3 sessions weekly for 3 months with maximum dose 1400 mJ/cm2. | Radiation | Narrow band Ultraviolet B phototherapy group |
| Acitretin groupdose of 0.5-1 mg per kg per day orally for 3 month. | Drug | Acitretin group |
| Acitretin plus Narrow band Ultraviolet B phototherapy groupAcitretin in dose of 0.5-1 mg per kg per day orally plus Narrow band Ultraviolet B phototherapy 3 sessions weekly for 3 months with maximum dose 1400 mJ/cm2. | Combination product | Acitretin plus Narrow band Ultraviolet B phototherapy group |
Primary outcome
Improve the prognosis of patients with psoriasis Vulgaris
Time frame: 3 month
detect the effect of Acitretin alone and Narrow band Ultraviolet B phototherapy alone versus combined therapy on genetic mutation and level of plexin b2 in patients with psoriasis Vulgaris
1 secondary outcome
Improve the clinical out comes of patients with psoriasis Vulgaris
Time frame: 12 month
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Sep 2023.
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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.
Eisa Hegazy, Prof. study chair
Faculty of Medicine, South Valley University, Egypt
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Narrow band Ultraviolet B phototherapy group, Acitretin group and Acitretin plus Narrow band Ultraviolet B phototherapy group in people with Psoriasis Vulgaris, run by South Valley 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 2 inclusion and 1 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: finished, as of the sponsor's last update on 21 Sep 2023. 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Improve the prognosis of patients with psoriasis Vulgaris (time frame: 3 month). 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 21 Sep 2023.