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

NCT05203354 | Completed Phase 4 DMC

• 1 other identifier: 288/9/18
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Psoriasis

Outcome Measures

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

  3 months

Secondary Outcomes (1)

• Decrease PASI score in psoriatic patients

  3 months

Study Arms (3)

NB-UVB group

ACTIVE COMPARATOR

Patients who receive Narrowband ultraviolet B phototherapy

Radiation: Narrowband Ultraviolet B

Acitretin group

ACTIVE COMPARATOR

Patients who receive acitretin

Drug: Acitretin

Control group

NO INTERVENTION

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

Interventions

Narrowband Ultraviolet B RADIATION

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

Also known as: NB-UVB phototherapy

NB-UVB group

Acitretin DRUG

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

Acitretin group

Eligibility Criteria

• Age: 20 Years - 50 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Patients of both sexes with psoriasis vulgaris.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Mahmoud Ahmed Ali Ahmed: lead

Study Sites (1)

Faculty of medicine - Aswan university

Aswān, 81528, Egypt

Location

MeSH Terms

Conditions

Psoriasis

Interventions

Acitretin

Condition Hierarchy (Ancestors)

Skin Diseases, Papulosquamous; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Retinoids; Carotenoids; Polyenes; Alkenes; Hydrocarbons, Acyclic; Hydrocarbons; Organic Chemicals; Terpenes; Pigments, Biological; Biological Factors

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Assistant lecturer

Study Record Dates

• First Submitted: December 14, 2021
• First Posted: January 24, 2022
• Study Start: September 1, 2018
• Primary Completion: May 1, 2021
• Study Completion: August 15, 2021
• Last Updated: January 24, 2022

Record last verified: 2022-01

Locations

EG (1)