NCT02004847

Blue Light for Treating Psoriasis Vulgaris

Monocenter, Randomized, Double Blinded, Intraindividual, Exploratory Study of Effectiveness and Safety of 3 Months Treatment With 2 Peak Intensities of 453nm Blue Light for the Treatment of Mild Plaque Type Psoriasis Vulgaris

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 47 (actual)
• Sponsor: Philips Electronics Nederland BV · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to determine the efficacy and safety of a blue light device for treating Psoriasis vulgaris. The study will compare a blue light treated plaque with an untreated control plaque. Additionally, two intensities of blue light are compared.

Detailed description

Blue light has been shown to release bioactive nitric oxide (NO) from nitrite and nitrosated proteins found in high concentrations in the skin. This bioactive NO has many physiological functions regulating immune responses, proliferation / differentiation as well as local blood Perfusion of the skin. The study will test the PSO-CT02 device, an new investigational medical device emitting blue light with a peak wavelength of 453nm on treating localised mild Psoriasis vulgaris. It can be worn on the Skin above the effected skin area. In this study Treatment (target) and control area as well as intensity of blue light are randomized. The control area will serve as reference. 50 Patients will treat the target area daily (at least 5 times/week) at home for an initial treatment period of 4 weeks. During those 4 weeks, patients will return to the study site for safety and effectiveness assessments twice. After this initiation period patients will treat their plaque for further 8 weeks (3 times/week). This is followed by a 4 week follow up phase without treatment.

Conditions

• Psoriasis Vulgaris

Interventions

Type	Name	Description
DEVICE	PSO-CT02	The PSO-CT02 device is a non CE marked investigational medical device that is worn on the affected skin area where it irradiates the Psoriasis plaque for 30 minutes with blue light.

Timeline

• Start date: 2013-09-01
• Primary completion: 2014-05-01
• Completion: 2014-05-01
• First posted: 2013-12-09
• Last updated: 2015-12-18
• Results posted: 2015-11-18

Locations

1 site across 1 country: Germany