Psoriatic ConditionsNCT06712238
Evaluation The Effect of NB-UVB and Methotrexate on The Level of Serum Gelsolin in Psoriatic Patients
A study testing NB-UVB in people with Psoriatic Conditions, run by Aswan University at 1 site in Egypt.
Trial summary
Psoriasis is a common chronic, immune-mediated, skin disease with a significantly negative impact on patients' quality of life. It is one of papulosquamous diseases defined by erythematous plaques with silvery scales. Read more about this study
- Who is it for?
- Ages 15 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Psoriatic Conditions
- What is being tested?
- NB-UVB
- Type of treatment
- Pill or oral medicine, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 48 participants
- Where
- 1 siteEgypt
- Study dates
- 10 Jun 2024to 10 Jun 2025
- 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 15 to 65 years
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Patients with moderate to severe plaque psoriasis.
- No restriction of age, race nor occupation.
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 diseases, chronic renal failure or cancer.
Trial locations and contacts
1 site in 1 country.
Egypt1 site, 1 recruiting
- Recruiting
Aswan University Hospital
Aswān
Nourhan Salah Mohamed, Resident, +201124152433, dr.nourhan505@gmail.com
Mohamed Amer Ahmed Abdellatif, +201060394083, mohammed.abdellatif@aswu.edu.eg
About this study
Psoriasis is a common chronic, immune-mediated, skin disease with a significantly negative impact on patients' quality of life. It is one of papulosquamous diseases defined by erythematous plaques with silvery scales.
The interplay among cytokines released by dendritic, Th1, Th2, and Th17 cells leads to the clinical manifestations seen in psoriasis. Although discovering novel biomarkers for psoriasis is challenging step., it may play an essential role in diagnosis, severity assessment and prediction of treatment outcome and prognosis of the disease
Read the detailed description
The protein expression of gelsolin- which is an actin scavenger controlling cytoskeletal remodeling, cell morphology, differentiation, movement, and apoptosis- has been found to be significantly decreased in several pathological conditions including neurodegenerative diseases, inflammatory disorders, and cancers.
Gelsolin (GSN) is a member of the GSN protein family, the main function of it is to cut and seal actin filaments to regulate the cytoskeleton and participate in a variety of biological functions.
Low serum gelsolin levels are linked to the severity of psoriasis, suggesting that gelsolin may help in assessing the severity of the disease and how it responds to treatment.
Methotrexate (MTX) is the first-choice drug when phototherapy or retinoid treatment are not effective in psoriatic patients.
It is a cytotoxic drug with powerful anti-proliferative and anti-inflammatory effects that has gained prominence in treating inflammatory diseases one of them is psoriasis.
Narrowband (NB) UVB phototherapy is a common line of treatment in psoriasis. It was proven to be more effective than broadband UVB and safer and/or more practicable than psoralen_UVA in treatment of psoriasis
- Conditions
- Psoriatic Conditions
- Being tested
- NB-UVB
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NB-UVBProcedure or surgery
Also called Methotrexate
Comparison between serum Level of Gelsolin (GSN) in Psoriatic Patients and controls and correlate its level with PASI.
| Study group | Role | What they receive |
|---|---|---|
| Group A: (Narrow Band Ultraviolet B) | Active comparator | About 12 patients will expose to 24 sessions of Narrow Band Ultraviolet B (NB-UVB) radiation (initial dose of 130 - 400 mJ / cm2 ) selected according to skin for 3 month. Receives: Procedure: NB-UVB |
| Group B: (Methotrexate ) | Active comparator | About 12 patients will receive Methotrexate tablets (MTX) in dose of (0.3 mg/kg/week) along with folic acid (5 mg/day) for 3 month. Receives: Procedure: NB-UVB |
| Group C: (Methotrexate and Narrow Band Ultraviolet B) | Active comparator | About 12 patients will undergo the treatment by both Methotrexate tablets (MTX) and Narrow Band Ultraviolet B( NB-UVB) radiation.for 3 month. Receives: Procedure: NB-UVB |
| Group D (Control Group) | Active comparator | About 12 patients apparently healthy individuals as control group.and will not take any medication Receives: Procedure: NB-UVB |
What is being measured
The primary outcome is the main question the study is designed to answer.
Treatment of the Psoriasis
About 36 patients suffering from Psoriasis and will be treated by exposing to Narrow band ultraviolet B radiation (initial dose of 130 - 400 mJ / cm2 selected according to skin phototype and gradual increase after each session ), and taking Methotrexate tablets in dose of (0.3 mg/kg/week) along with folic acid (5 mg/day) .
Measured: 3 months
Serum Gelsolin Evaluation
Evaluation the Serum Gelsolin level in Psoriatic Patients after treatment by Narrow band ultraviolet B and taking Methotrexate tablets.
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 posted2 Dec 2024
- Study start10 Jun 2024
- Primary completion1 Jun 2025 (estimated)
- Study completion10 Jun 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Psoriatic ConditionsStudies 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 48 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Aswan University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Nourhan Salah Mohamed, Aswan University
- Investigators
- Moustafa Adam Ali El Taieb, Professor, Study chair, Dermatology, Venereology and Andrology.Faculty of Medicine, Aswan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06712238
- Sponsor's protocol ID
- Nourhan Salah
- Status last verified
- Jun 2024
- First submitted
- 20 Nov 2024
- Last updated
- 2 Dec 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 2 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation The Effect of NB-UVB and Methotrexate on The Level of Serum Gelsolin in Psoriatic Patients
- ClinicalTrials.gov ID
- NCT06712238
- Acronym / sponsor ID
- Nourhan Salah
- Conditions
- Psoriatic Conditions
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 48 participants (estimated)
- Lead sponsor
- Aswan UniversityUniversity, hospital or other
- Study start
- 10 Jun 2024 (actual)
- Primary completion
- 1 Jun 2025 (estimated)
- Study completion
- 10 Jun 2025 (estimated)
- First posted
- 2 Dec 2024 (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 a common chronic, immune-mediated, skin disease with a significantly negative impact on patients' quality of life. It is one of papulosquamous diseases defined by erythematous plaques with silvery scales.
The interplay among cytokines released by dendritic, Th1, Th2, and Th17 cells leads to the clinical manifestations seen in psoriasis. Although discovering novel biomarkers for psoriasis is challenging step., it may play an essential role in diagnosis, severity assessment and prediction of treatment outcome and prognosis of the disease
Detailed description
The protein expression of gelsolin- which is an actin scavenger controlling cytoskeletal remodeling, cell morphology, differentiation, movement, and apoptosis- has been found to be significantly decreased in several pathological conditions including neurodegenerative diseases, inflammatory disorders, and cancers.
Gelsolin (GSN) is a member of the GSN protein family, the main function of it is to cut and seal actin filaments to regulate the cytoskeleton and participate in a variety of biological functions.
Low serum gelsolin levels are linked to the severity of psoriasis, suggesting that gelsolin may help in assessing the severity of the disease and how it responds to treatment.
Methotrexate (MTX) is the first-choice drug when phototherapy or retinoid treatment are not effective in psoriatic patients.
It is a cytotoxic drug with powerful anti-proliferative and anti-inflammatory effects that has gained prominence in treating inflammatory diseases one of them is psoriasis.
Narrowband (NB) UVB phototherapy is a common line of treatment in psoriasis. It was proven to be more effective than broadband UVB and safer and/or more practicable than psoralen_UVA in treatment of psoriasis
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Group A: (Narrow Band Ultraviolet B) | Active comparator | Procedure: NB-UVBAbout 12 patients will expose to 24 sessions of Narrow Band Ultraviolet B (NB-UVB) radiation (initial dose of 130 - 400 mJ / cm2 ) selected according to skin for 3 month. |
| Group B: (Methotrexate ) | Active comparator | Procedure: NB-UVBAbout 12 patients will receive Methotrexate tablets (MTX) in dose of (0.3 mg/kg/week) along with folic acid (5 mg/day) for 3 month. |
| Group C: (Methotrexate and Narrow Band Ultraviolet B) | Active comparator | Procedure: NB-UVBAbout 12 patients will undergo the treatment by both Methotrexate tablets (MTX) and Narrow Band Ultraviolet B( NB-UVB) radiation.for 3 month. |
| Group D (Control Group) | Active comparator | Procedure: NB-UVBAbout 12 patients apparently healthy individuals as control group.and will not take any medication |
Who may qualify
- Ages
- 15 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- Patients with moderate to severe plaque psoriasis.
- No restriction of age, race nor occupation.
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 diseases, 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 |
|---|---|---|
| NB-UVBAlso: MethotrexateComparison between serum Level of Gelsolin (GSN) in Psoriatic Patients and controls and correlate its level with PASI. | Procedure or surgery | Group A: (Narrow Band Ultraviolet B), Group B: (Methotrexate ), Group C: (Methotrexate and Narrow Band Ultraviolet B), Group D (Control Group) |
Primary outcome
Treatment of the Psoriasis
Time frame: 3 months
About 36 patients suffering from Psoriasis and will be treated by exposing to Narrow band ultraviolet B radiation (initial dose of 130 - 400 mJ / cm2 selected according to skin phototype and gradual increase after each session ), and taking Methotrexate tablets in dose of (0.3 mg/kg/week) along with folic acid (5 mg/day) .
Serum Gelsolin Evaluation
Time frame: 3 Months
Evaluation the Serum Gelsolin level in Psoriatic Patients after treatment by Narrow band ultraviolet B and taking Methotrexate tablets.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Dec 2024.
- Individual participant dataSharing planned: Undecided
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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 Adam Ali El Taieb, Professor study chair
Dermatology, Venereology and Andrology.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 study testing NB-UVB in people with Psoriatic Conditions, run by Aswan 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 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 2 Dec 2024. 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 Nourhan Salah Mohamed, Resident (+201124152433, dr.nourhan505@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Treatment of the Psoriasis (time frame: 3 months). The study lists 2 primary outcomes in all. 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 2 Dec 2024.