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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02599415
Other study ID # 2/044/14
Secondary ID
Status Completed
Phase N/A
First received March 6, 2015
Last updated March 24, 2016
Start date September 2014
Est. completion date December 2014

Study information

Verified date March 2016
Source University of Aberdeen
Contact n/a
Is FDA regulated No
Health authority United Kingdom: Research Ethics Committee
Study type Interventional

Clinical Trial 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.


Description:

Six patients with plaque psoriasis were recruited from the phototherapy unit. These patients were referred by their dermatologist to receive narrow-band UVB (TL01) light treatment. Two 6 mm lesional skin punch biopsies were taken at baseline and 2 weeks after commencing the light treatment to study the effect of light on innate immune cells involved in psoriasis pathogenesis.


Recruitment information / eligibility

Status Completed
Enrollment 6
Est. completion date December 2014
Est. primary completion date December 2014
Accepts healthy volunteers No
Gender Both
Age group 18 Years to 70 Years
Eligibility Inclusion Criteria:

- 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.

Exclusion Criteria:

- 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

Study Design

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic


Related Conditions & MeSH terms


Intervention

Device:
TL01 light treatment
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.

Locations

Country Name City State
United Kingdom University of Aberdeen Aberdeen

Sponsors (2)

Lead Sponsor Collaborator
University of Aberdeen NHS Grampian

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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 No
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