Anti-psoriatic Effect of TL01 Light Therapy

Psoriasis Clinical Trial

Official title:

Studying the Effect of Narrow Band Ultraviolet B Phototherapy on Skin Dendritic (DCs) Cells in Psoriasis Patients

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02599415
• Other study ID #: 2/044/14
• 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

• Psoriasis

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