NCT02599415

Brief Summary

This is a pilot study to investigate the effect of TL01 narrow band UVB therapy on the resident dermal dendritic cells characterized by expression of CD1c and CD141. These cells were reported to have a role in induction of tolerogenic regulatory T cells and production of IL-10. The investigators proposed to investigate the effect of NB-UVB on these subsets of cells after two weeks of treatment to provide better understanding of the mechanism of action of light treatment.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
6

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Sep 2014

Shorter than P25 for not_applicable

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, 2014

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2014

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

March 6, 2015

Completed
8 months until next milestone

First Posted

Study publicly available on registry

November 6, 2015

Completed
Last Updated

March 25, 2016

Status Verified

March 1, 2016

Enrollment Period

3 months

First QC Date

March 6, 2015

Last Update Submit

March 24, 2016

Conditions

Psoriasis

Keywords

psoriasis patients referred to receive TL01 NB-UVB therapy

Outcome Measures

Primary Outcomes (1)

  • determination of the effect of TL01 NB-UVB on numbers of CD1c and CD141 cells

    no adverse events recorded after two weeks of TL01 treatment

    3 months

Study Arms (1)

TL01 light treatment

OTHER

routine treatment with a CE marked device that has been used for this disease for many years

Device: TL01 light treatment

Interventions

TL01 light treatmentDEVICE

Patients received treatment in TL01 cabinet three sessions weekly according to a standard escalating protocol based on minimal erythema dose. Standard dose ranges between 0.55 and 3.13J/cm2.

Also known as: Waldmnn Gmbh cabinet
TL01 light treatment

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Male and female psoriasis patients in whom the decision to treat with NB-UVB therapy, as part of their routine clinical care, has been taken by their dermatologist in the age range of 18-70 years.

You may not qualify if:

  • patients currently on antipsoriatic treatment.
  • Patients with immunosuppressive diseases
  • Patients on immunosuppressive therapies
  • Pregnant or lactating female patients
  • Patients unable to provide a written consentProcedure

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Aberdeen

Aberdeen, AB25 2zb, United Kingdom

Location

MeSH Terms

Conditions

Psoriasis

Condition Hierarchy (Ancestors)

Skin Diseases, PapulosquamousSkin DiseasesSkin and Connective Tissue Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 6, 2015

First Posted

November 6, 2015

Study Start

September 1, 2014

Primary Completion

December 1, 2014

Study Completion

December 1, 2014

Last Updated

March 25, 2016

Record last verified: 2016-03

Data Sharing

IPD Sharing
Will not share

Locations

GB(1)