Back to resultsAnti-psoriatic Effect of TL01 Light Therapy
Primary Purpose
Psoriasis
Status
Completed
Phase
Not Applicable
Locations
United Kingdom
Study Type
Interventional
Intervention
TL01 light treatment
Sponsored by
About this trial
This is an interventional diagnostic trial for Psoriasis focused on measuring psoriasis patients referred to receive TL01 NB-UVB therapy
Eligibility Criteria
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
Sites / Locations
- University of Aberdeen
Arms of the Study
Arm 1
Arm Type
Other
Arm Label
TL01 light treatment
Arm Description
routine treatment with a CE marked device that has been used for this disease for many years
Outcomes
Primary Outcome Measures
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
Secondary Outcome Measures
Full Information
NCT ID
NCT02599415
First Posted
March 6, 2015
Last Updated
March 24, 2016
Sponsor
University of Aberdeen
Collaborators
NHS Grampian
1. Study Identification
Unique Protocol Identification Number
NCT02599415
Brief Title
Anti-psoriatic Effect of TL01 Light Therapy
Official Title
Studying the Effect of Narrow Band Ultraviolet B Phototherapy on Skin Dendritic (DCs) Cells in Psoriasis Patients
Study Type
Interventional
2. Study Status
Record Verification Date
March 2016
Overall Recruitment Status
Completed
Study Start Date
September 2014 (undefined)
Primary Completion Date
December 2014 (Actual)
Study Completion Date
December 2014 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Aberdeen
Collaborators
NHS Grampian
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
Detailed 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Psoriasis
Keywords
psoriasis patients referred to receive TL01 NB-UVB therapy
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
6 (Actual)
8. Arms, Groups, and Interventions
Arm Title
TL01 light treatment
Arm Type
Other
Arm Description
routine treatment with a CE marked device that has been used for this disease for many years
Intervention Type
Device
Intervention Name(s)
TL01 light treatment
Other Intervention Name(s)
Waldmnn Gmbh cabinet
Intervention Description
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.
Primary Outcome Measure Information:
Title
determination of the effect of TL01 NB-UVB on numbers of CD1c and CD141 cells
Description
no adverse events recorded after two weeks of TL01 treatment
Time Frame
3 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
University of Aberdeen
City
Aberdeen
ZIP/Postal Code
AB25 2zb
Country
United Kingdom
12. IPD Sharing Statement
Plan to Share IPD
No
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Anti-psoriatic Effect of TL01 Light Therapy
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