NCT05401006

Brief Summary

To evaluate effect of acitretin versus Narrowband UVB on serum level of neopterin in psoriatic patients.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
30

participants targeted

Target at below P25 for phase_4

Timeline
Completed

Started Jun 2021

Geographic Reach
1 country

1 active site

Status
unknown

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 5, 2021

Completed
12 months until next milestone

First Submitted

Initial submission to the registry

May 27, 2022

Completed
6 days until next milestone

First Posted

Study publicly available on registry

June 2, 2022

Completed
3 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 5, 2022

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

June 5, 2023

Completed
Last Updated

June 2, 2022

Status Verified

May 1, 2022

Enrollment Period

1 year

First QC Date

May 27, 2022

Last Update Submit

May 27, 2022

Conditions

Outcome Measures

Primary Outcomes (1)

  • 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).

    3 Months

Secondary Outcomes (1)

  • Treatment of psoriasis

    3 Months

Study Arms (3)

Acitretin

ACTIVE COMPARATOR

Patients will Receive Acitretin (0.25-1 mg /kg/day )for 3months .

Drug: Acitretin 25Mg Cap

Narrowband ultraviolet B

ACTIVE COMPARATOR

Patients will receive Narrowband UVB( 3session /week ) for 3months.

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.

Drug: Acitretin 25Mg CapRadiation: Narrowband ultraviolet B

Interventions

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

AcitretinCombination of Narrowband ultraviolet B and Acitretin

Narrowband UVB is the most common form of phototherapy used to treat psoriasis, given 2-3 sessions per week for 3 successive months

Also known as: Narrowband UVB
Combination of Narrowband ultraviolet B and AcitretinNarrowband ultraviolet B

Eligibility Criteria

Age15 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

South Valley University

Qina, Egypt

Location

MeSH Terms

Conditions

Psoriasis

Interventions

AcitretinCapsules

Condition Hierarchy (Ancestors)

Skin Diseases, PapulosquamousSkin DiseasesSkin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

RetinoidsCarotenoidsPolyenesAlkenesHydrocarbons, AcyclicHydrocarbonsOrganic ChemicalsTerpenesPigments, BiologicalBiological FactorsDosage FormsPharmaceutical Preparations

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Resident doctor

Study Record Dates

First Submitted

May 27, 2022

First Posted

June 2, 2022

Study Start

June 5, 2021

Primary Completion

June 5, 2022

Study Completion

June 5, 2023

Last Updated

June 2, 2022

Record last verified: 2022-05

Locations