Anti-psoriatic Effect of TL01 Light Therapy

Not Applicable

Completed

• Conditions: Psoriasis
• Interventions: Device: TL01 light treatment

• Registration Number: NCT02599415
• Lead Sponsor: University of Aberdeen

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.

Study Timeline

• Study Start: 2014-09
• Primary Completion: 2014-12
• Study Completion: 2014-12
• Study First Submitted: 2015-03-06
• Study First Submitted QC: 2015-11-04
• Study First Posted: 2015-11-06
• Status Verified: 2016-03
• Last Update Submitted: 2016-03-24
• Last Update Posted: 2016-03-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 6

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

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
TL01 light treatment	TL01 light treatment	routine treatment with a CE marked device that has been used for this disease for many years

Primary Outcome Measures

Name	Time	Method
determination of the effect of TL01 NB-UVB on numbers of CD1c and CD141 cells	3 months	no adverse events recorded after two weeks of TL01 treatment

Trial Locations

Locations (1)

University of Aberdeen; 🇬🇧 Aberdeen, United Kingdom