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Completed

NCT Number: NCT02599415

Anti-psoriatic Effect of TL01 Light Therapy

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.

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Key information

Conditions

Psoriasis Skin Diseases Skin Diseases, Papulosquamous Skin and Connective Tissue Diseases

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Aberdeen

Aberdeen, AB25 2zb, United Kingdom

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

TL01 light treatment

Device

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.

Other names: Waldmnn Gmbh cabinet

Primary outcomes

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

    Time frame: 3 months

    no adverse events recorded after two weeks of TL01 treatment

Sponsors and collaborators

Lead sponsor

University of Aberdeen

Other

Collaborators

  • NHS Grampian

Registry information

Official study title

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

Important dates

Study start
2014
Primary completion
2014
Study completion
2014
First posted
Nov 6, 2015
Registry last updated
Mar 25, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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