Effect of Acitretin Versus Narrowband Ultraviolet B on Neopterin Level in Psoriatic Patients .

May 27, 2022 updated by: Fatma Elsayed abd Elfatah Elsayed, South Valley University

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.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

30

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Egypt
      • Qinā, Egypt
        • South Valley University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

15 years to 60 years (Child, Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Patients with psoriasis diagnosed clinically Aged (15-60).

Exclusion Criteria:

  • Patient with history of skin cancer.
  • Patient with history of photosensitivity.
  • Pregnancy and lactation.
  • Liver failure.
  • Renal failure.
  • Patient with psoriatic artheritis.
  • Patient with allergy to product or any of its components.
  • Patient with poorly controlled dyslipidemia.
  • Patient receiving tetracyclines.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Acitretin
Patients will Receive Acitretin (0.25-1 mg /kg/day )for 3months .
Drug: Acitretin 25Mg Cap
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
Active Comparator: Narrowband ultraviolet B
Patients will receive Narrowband UVB( 3session /week ) for 3months.
Radiation: Narrowband ultraviolet B
Narrowband UVB is the most common form of phototherapy used to treat psoriasis, given 2-3 sessions per week for 3 successive months
Other Names:
  • Narrowband UVB
Active Comparator: Combination of Narrowband ultraviolet B and Acitretin
Patients will receive Acitretin (0.25-1 mg /kg/day ) and Narrowband UVB( 3session /week ) for 3 months.
Drug: Acitretin 25Mg Cap
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
Radiation: Narrowband ultraviolet B
Narrowband UVB is the most common form of phototherapy used to treat psoriasis, given 2-3 sessions per week for 3 successive months
Other Names:
  • Narrowband UVB

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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).
3 Months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Treatment of psoriasis
Time Frame: 3 Months
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.
3 Months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

South Valley University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 5, 2021

Primary Completion (Anticipated)

June 5, 2022

Study Completion (Anticipated)

June 5, 2023

Study Registration Dates

First Submitted

May 27, 2022

First Submitted That Met QC Criteria

May 27, 2022

First Posted (Actual)

June 2, 2022

Study Record Updates

Last Update Posted (Actual)

June 2, 2022

Last Update Submitted That Met QC Criteria

May 27, 2022

Last Verified

May 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 209/6/21

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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