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CompletedNCT05203354Updated Jan 24, 2022

Omentin-1 Level in Psoriatic Patients Treated With Narrowband Ultraviolet B Phototherapy Versus Acitretin

A Phase 4 interventional study of Narrowband Ultraviolet B and Acitretin in Psoriasis, sponsored by Mahmoud Ahmed Ali Ahmed. Completed at 1 site in Egypt. Open to participants aged 20 Years to 50 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2022-01-24.

Sponsored by Mahmoud Ahmed Ali Ahmed · Phase 4, Interventional, and Treatment

From the registry’s dates

  • Registered 3 years 3 months after the study started (first participant enrolled Sep 2018, registered Dec 2021).
Phase
Phase 4
Study type
Interventional
Enrollment
60
Allocation
Randomized
Ages
20 Years to 50 Years
Sex
All
01

Study summary

Studying the effects of Narrowband Ultraviolet B versus acitretin on psoriatic patients

Read the detailed description

Compare the effects of Narrowband Ultraviolet B versus acitretin on serum Omentin-1 level in psoriatic patients as case control study by dividing patients into 3 groups: group 1 include patients receive Narrowband Ultraviolet B, group II includes patients receive acitretin (0.5-1 mg/day) and control group. The duration of this study about 3 months after receving those interventions.

02

Conditions studied

  • Psoriasis

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03

In context

Psoriasis

1,928 studies on the registry are indexed under Psoriasis; 234 are open to participants now.

This study's enrollment of 60 is below the median of 70 across 1,472 interventional studies indexed under Psoriasis.

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Lead sponsor

This is the only study on the registry with Mahmoud Ahmed Ali Ahmed as lead sponsor.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
20 Years to 50 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Patients of both sexes with psoriasis vulgaris.

Exclusion criteria

Exclusion Criteria:

    • Patients with history of malignancies, renal and liver diseases.

      • Patients received NB-UVB phototherapy in the last 6 months.
      • Patients treated with methotrexate or biologic agents and any systemic treatment of psoriasis.
05

Study design

Phase
Phase 4
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Investigator, Outcomes assessor)
Enrollment
60 participants (actual)

Study arms

  • Active comparator
    NB-UVB group

    Patients who receive Narrowband ultraviolet B phototherapy

    Radiation: Narrowband Ultraviolet B

  • Active comparator
    Acitretin group

    Patients who receive acitretin

    Drug: Acitretin

  • No intervention
    Control group

    It includes apparently healthy people who will be compared to patients in the measurement of Omentin-1 level

Interventions

  • RadiationNarrowband Ultraviolet B

    patients will exposed to sessions of NB-UVB phototherapy twice weekly for 3 months

    Also known as: NB-UVB phototherapy

  • patients will received acitretin in dose 0.5-1 mg/kg daily for 3 months

06

What researchers measure

Primary outcomes

  1. Decrease Omentin-1 serum level in both groups treated with NB-UVB and Acitretin

    This outcome indicates potential role of Omentin-1 in psoriasis pathogenesis and its involvement in pathogenesis of obesity and related diseases as metabolic syndrome. So it will be concluded that high levels of this protein could be marker against obesity and related disorders including psoriasis. Omentin-1 can be valuable marker for psoriasis severity detected by its correlation with psoriasis area severity index (PASI) score and for evaluating the therapeutic outcomes

    Time frame: 3 months

Secondary outcomes

  1. Decrease PASI score in psoriatic patients

    Decrease in PASI score in psoriatic patients after treatment with NB-UVB acitretin

    Time frame: 3 months

07

Study locations

1 site
  • Faculty of medicine - Aswan university
    Aswān, 81528, Egypt
08

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Ran from Sep 2018 to primary completion in May 2021, 32 months.

Of 68 non-industry phase 4 interventional studies under Psoriasis, half reached primary completion within 25 months of starting (the median), counting those still running; a quarter within 11 and three quarters within 43. This study's 32 months is above that.

Counting every sponsor, half of 107 studies reached it within 23 months; a quarter within 11 and three quarters within 39.

How these figures are worked out, and which studies are left out of them.

Registered
Dec 14, 2021
First posted
Jan 24, 2022
StartActual
Sep 1, 2018
Primary completionActual
May 1, 2021
CompletionActual
Aug 15, 2021
Last update
Jan 24, 2022
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Jan 24, 2022, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT05203354
Lead sponsor
Mahmoud Ahmed Ali Ahmed
Responsible party
Mahmoud Ahmed Ali Ahmed (Assistant lecturer, Aswan University Hospital) — Sponsor-investigator
First posted
Jan 24, 2022
Start date
Sep 1, 2018
Primary completion
May 1, 2021
Completion
Aug 15, 2021
Last update
Jan 24, 2022

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jan 2022. You cannot join it, but the record below documents what was studied.

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Studies of the drug tested here: Acitretin

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