PsoriasisPhase 4NCT05401006
Effect of Acitretin Versus Narrowband Ultraviolet B on Neopterin Level in Psoriatic Patients .
A Phase 4 study testing Acitretin 25Mg Cap and Narrowband ultraviolet B in people with Psoriasis, run by South Valley University at 1 site in Egypt.
Trial summary
To evaluate effect of acitretin versus Narrowband UVB on serum level of neopterin in psoriatic patients. Read more about this study
- Who is it for?
- Ages 15 to 60 years
- Conditions the study is for
- Psoriasis
- What is being tested?
- Acitretin 25Mg Cap and Narrowband ultraviolet B
- Type of treatment
- Pill or oral medicine, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteEgypt
- Study dates
- 5 Jun 2021to 5 Jun 2023
- Phase
- Phase 4
- 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 60 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Patients with psoriasis diagnosed clinically Aged (15-60).
Who cannot join
- Patient with history of skin cancer.
- Patient with history of photosensitivity.
- Pregnancy and lactation.
- Liver failure.
- Renal failure.
- Patient with psoriatic artheritis.
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- Patient with allergy to product or any of its components.
- Patient with poorly controlled dyslipidemia.
- Patient receiving tetracyclines.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evaluation of the Effect of Acitretin Versus Narrowband Ultraviolet B on Serum Neopterin Level in Psoriatic Patients .
To evaluate effect of acitretin versus Narrowband UVB on serum level of neopterin in psoriatic patients.
- Conditions
- Psoriasis
- Being tested
- Acitretin 25Mg Cap, Narrowband ultraviolet B
- Medical subject headings
- Psoriasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Acitretin 25Mg CapDrug
Acitretin is an oral retinoid (a derivative of vitamin A) given in a dose 0.25-1 mg /kg/day for 3months in psoriatic patients
Narrowband ultraviolet BRadiation
Also called Narrowband UVB
Narrowband UVB is the most common form of phototherapy used to treat psoriasis, given 2-3 sessions per week for 3 successive months
| Study group | Role | What they receive |
|---|---|---|
| Acitretin | Active comparator | Patients will Receive Acitretin (0.25-1 mg /kg/day )for 3months . Receives: Drug: Acitretin 25Mg Cap |
| Narrowband ultraviolet B | Active comparator | Patients will receive Narrowband UVB( 3session /week ) for 3months. Receives: Radiation: Narrowband ultraviolet B |
| Combination of Narrowband ultraviolet B and Acitretin | Active comparator | Patients will receive Acitretin (0.25-1 mg /kg/day ) and Narrowband UVB( 3session /week ) for 3 months. Receives: Drug: Acitretin 25Mg Cap; Radiation: Narrowband ultraviolet B |
What is being measured
The primary outcome is the main question the study is designed to answer.
Serum Neopterin in psoriasis
Measurement of Neopterin in psoriatic patients before and after treatment with NB-UVB, Acitretin and combination of both modalities using ELISA (enzyme-linked immunosorbent assay).
Measured: 3 Months
Secondary outcomes (1)
Treatment of psoriasis
Clinical evaluation: Assessment of disease severity will be performed by using psoriasis area severity index (PASI score) before and after treatment with NB-UVB, Acitretin and combination of both modalities.
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 Jun 2022
- Study start5 Jun 2021
- Primary completion5 Jun 2022 (estimated)
- Study completion5 Jun 2023 (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.
- 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- South Valley University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Fatma Elsayed abd Elfatah Elsayed, South Valley University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05401006
- Sponsor's protocol ID
- 209/6/21
- Status last verified
- May 2022
- First submitted
- 27 May 2022
- Last updated
- 2 Jun 2022
- 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 2 Jun 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Effect of Acitretin Versus Narrowband Ultraviolet B on Serum Neopterin Level in Psoriatic Patients .
- ClinicalTrials.gov ID
- NCT05401006
- Acronym / sponsor ID
- 209/6/21
- Conditions
- Psoriasis
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- South Valley UniversityUniversity, hospital or other
- Study start
- 5 Jun 2021 (actual)
- Primary completion
- 5 Jun 2022 (estimated)
- Study completion
- 5 Jun 2023 (estimated)
- First posted
- 2 Jun 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.
To evaluate effect of acitretin versus Narrowband UVB on serum level of neopterin in psoriatic patients.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Acitretin | Active comparator | Drug: Acitretin 25Mg CapPatients will Receive Acitretin (0.25-1 mg /kg/day )for 3months . |
| Narrowband ultraviolet B | Active comparator | Radiation: Narrowband ultraviolet BPatients will receive Narrowband UVB( 3session /week ) for 3months. |
| Combination of Narrowband ultraviolet B and Acitretin | Active comparator | Drug: Acitretin 25Mg Cap, Radiation: Narrowband ultraviolet BPatients will receive Acitretin (0.25-1 mg /kg/day ) and Narrowband UVB( 3session /week ) for 3 months. |
Who may qualify
- Ages
- 15 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (1 listed)
- Patients with psoriasis diagnosed clinically Aged (15-60).
Key exclusion criteria (9 listed)
- Patient with history of skin cancer.
- Patient with history of photosensitivity.
- Pregnancy and lactation.
- Liver failure.
- Renal failure.
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 |
|---|---|---|
| Acitretin 25Mg CapAcitretin is an oral retinoid (a derivative of vitamin A) given in a dose 0.25-1 mg /kg/day for 3months in psoriatic patients | Drug | Acitretin, Combination of Narrowband ultraviolet B and Acitretin |
| Narrowband ultraviolet BAlso: Narrowband UVBNarrowband UVB is the most common form of phototherapy used to treat psoriasis, given 2-3 sessions per week for 3 successive months | Radiation | Combination of Narrowband ultraviolet B and Acitretin, Narrowband ultraviolet B |
Primary outcome
Serum Neopterin in psoriasis
Time frame: 3 Months
Measurement of Neopterin in psoriatic patients before and after treatment with NB-UVB, Acitretin and combination of both modalities using ELISA (enzyme-linked immunosorbent assay).
1 secondary outcome
Treatment of psoriasis
Time frame: 3 Months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Jun 2022.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Acitretin 25Mg Cap and Narrowband ultraviolet B in people with Psoriasis, 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 1 inclusion and 9 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 Jun 2022. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
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?
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?
Serum Neopterin in psoriasis (time frame: 3 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 2 Jun 2022.