NCT03767114

Brief Summary

A 4mm Punch biopsy is obtained from lesional and non lesional skin of 25 psoraitic patients as well as of 30 controls. Skin biopsy from patients (psoriasis lesional and non lesional) \& control will be kept in lysis solution (which contains RNAase inhibitor) for the stability of the parameter to be assessed. ERAP-1 gene expression will Research Template 5 Final Version: 8/3/2 016 be detected by quantitative real time -PCR, which include RNA extraction, cDNA synthesis \& PCR.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
55

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jan 2017

Typical duration for not_applicable

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

January 1, 2017

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2017

Completed
1.5 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2018

Completed
4 days until next milestone

First Submitted

Initial submission to the registry

December 5, 2018

Completed
1 day until next milestone

First Posted

Study publicly available on registry

December 6, 2018

Completed
Last Updated

December 6, 2018

Status Verified

December 1, 2018

Enrollment Period

5 months

First QC Date

December 5, 2018

Last Update Submit

December 5, 2018

Conditions

Outcome Measures

Primary Outcomes (1)

  • Estimation of lesional ERAP1 in psoriatic skin

    DPCRetection of level of expression of ERAP 1 in lesional skin of psoriasis patients by RT-

    Maximum 2 years

Secondary Outcomes (1)

  • Estimation of non lesional ERAP1 in psoriatic skin

    Maximum 2 years

Study Arms (2)

cases of psoriasis

EXPERIMENTAL

group of 25 cases of psoriasis subjected to skin biopsy for detection of lesional and non lesional expression of ERAP1 by RT-PCR

Diagnostic Test: RT-PCR for ERAP1 detection

normal controls

EXPERIMENTAL

group of 30 age and sex matched healthy controls o subjected to skin biopsy from normal skin for detection of expression of ERAP1 by RT-PCR

Diagnostic Test: RT-PCR for ERAP1 detection

Interventions

Reverse transcriptase -Polymerase Chain Reaction for ERAP1 detection

cases of psoriasisnormal controls

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • patients with psoriasis vulgaris
  • patients over 18 years of age
  • both sexes

You may not qualify if:

  • patients on treatment for psoriasis within the last two months
  • assoiciated autoimmune diseases eg SLE
  • pregnancy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Psoriasis

Condition Hierarchy (Ancestors)

Skin Diseases, PapulosquamousSkin DiseasesSkin and Connective Tissue Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Lecturer of dermatology

Study Record Dates

First Submitted

December 5, 2018

First Posted

December 6, 2018

Study Start

January 1, 2017

Primary Completion

June 1, 2017

Study Completion

December 1, 2018

Last Updated

December 6, 2018

Record last verified: 2018-12