NCT05184348

Brief Summary

Patients will be randomly assigned (1:1:1 ) either to ; NB-UVB photo-therapy alone , Acitretin therapy alone or NB-UVB photo-therapy combined with Acitretin therapy randomization will be done by closed envelopes . investigator will be blinded to study drug assignment , while patients and data interpreter will not be masked to study drug assignment.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
200

participants targeted

Target at P75+ for phase_1

Timeline
Completed

Started Sep 2021

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2021

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

November 23, 2021

Completed
2 months until next milestone

First Posted

Study publicly available on registry

January 11, 2022

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 30, 2023

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 30, 2023

Completed
Last Updated

September 21, 2023

Status Verified

September 1, 2023

Enrollment Period

1.4 years

First QC Date

November 23, 2021

Last Update Submit

September 19, 2023

Conditions

Psoriasis Vulgaris

Outcome Measures

Primary Outcomes (1)

  • Improve the prognosis of patients with psoriasis Vulgaris

    detect the effect of Acitretin alone and Narrow band Ultraviolet B phototherapy alone versus combined therapy on genetic mutation and level of plexin b2 in patients with psoriasis Vulgaris

    3 month

Secondary Outcomes (1)

  • Improve the clinical out comes of patients with psoriasis Vulgaris

    12 month

Study Arms (4)

Narrow band Ultraviolet B phototherapy group

ACTIVE COMPARATOR

Patients will be treated with Narrow band Ultraviolet B phototherapy 3 sessions weekly for 3 months with maximum dose of 1400 mJ/cm2.

Radiation: Narrow band Ultraviolet B phototherapy group

Acitretin group

ACTIVE COMPARATOR

Patients will be treated with Acitretin in dose of 0.5-1 mg per kg per day orally for 3 months

Drug: Acitretin group

Acitretin plus Narrow band Ultraviolet B phototherapy group

ACTIVE COMPARATOR

Patients will be treated with Acitretin in dose of 0.5-1 mg per kg per day orally plus NB-UVB phototherapy 3 sessions weekly for 3 months with maximum dose 1400 mJ/cm2.

Combination Product: Acitretin plus Narrow band Ultraviolet B phototherapy group

Control group

NO INTERVENTION

30 healthy individuals un related , age, sex , BMI matched with volunteers.

Interventions

Narrow band Ultraviolet B phototherapy groupRADIATION

3 sessions weekly for 3 months with maximum dose 1400 mJ/cm2.

Also known as: NB-UVB
Narrow band Ultraviolet B phototherapy group
Acitretin groupDRUG

dose of 0.5-1 mg per kg per day orally for 3 month.

Acitretin group
Acitretin plus Narrow band Ultraviolet B phototherapy groupCOMBINATION_PRODUCT

Acitretin in dose of 0.5-1 mg per kg per day orally plus Narrow band Ultraviolet B phototherapy 3 sessions weekly for 3 months with maximum dose 1400 mJ/cm2.

Acitretin plus Narrow band Ultraviolet B phototherapy group

Eligibility Criteria

Age24 Years - 64 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Patients of both sexes. Diagnosed clinically with moderate to severe Psoriasis Vulgaris.
  • patients able to swallow tablet and receive Narrow band Ultraviolet B phototherapy without any contraindication

You may not qualify if:

  • Pregnancy , lactation \& women intent to become pregnant within 3 year after discontinuation of acitretin Patients with Hyperlipidemia Patients with mental problems and depression Patients with a history of malignancies, renal \& liver diseases. Patients with a history of any inflammatory diseases as atopic dermatitis , asthma ulcerative colitis ) and Crohn's disease Patients received NB-UVB phototherapy in the last 6 months. Patients treated with methotrexate or biologic agents and any systemic treatment of psoriasis.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Faculty of Medicine , South Valley University

Qina, Egypt

Location

MeSH Terms

Interventions

Acitretin

Intervention Hierarchy (Ancestors)

RetinoidsCarotenoidsPolyenesAlkenesHydrocarbons, AcyclicHydrocarbonsOrganic ChemicalsTerpenesPigments, BiologicalBiological Factors

Study Officials

  • Eisa Hegazy, Prof.

    Faculty of Medicine, South Valley University, Egypt

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assitant lecturer of Dermatology, Venereology & Andrology

Study Record Dates

First Submitted

November 23, 2021

First Posted

January 11, 2022

Study Start

September 1, 2021

Primary Completion

January 30, 2023

Study Completion

March 30, 2023

Last Updated

September 21, 2023

Record last verified: 2023-09

Locations

EG(1)