NCT02002871

Blue Light for Treating Eczema

Monocenter, Randomized, Intraindividual, Open Label, Exploratory Study Comparing 4 Weeks of Treatment With 453nm Blue Light With no Treatment in Patients With Eczema

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 21 (actual)
• Sponsor: Philips Electronics Nederland BV · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

Monocenter, randomized, intraindividual, open label, exploratory study comparing 4 weeks of treatment with 453nm blue light with no treatment in patients with Eczema. Patients will be screened up to 28 days before start of treatment. During the screening visit, the purpose and procedures of the study will be explained to potential patients and informed consent will be obtained. In addition, fungal superinfection of the target area will be examined using direct preparations and mycology cultures. At the baseline visit, patients with Eczema will be determined and all inclusion and exclusion criteria will be assessed. For eligible patients, two comparable treatment areas will be randomized to treatment with blue light (target area) or to serve as untreated control area. After randomization, patients will receive treatment of the target area with 3 applications per week at the investigational site for a total treatment period of 4 weeks. During those 4 weeks, safety and effectiveness assessments will be performed at weekly intervals. After end of treatment, the patients will be followed-up for another 2 weeks. In case no full resolution of adverse events occurred at the 2 week follow-up visit, a follow-up call will be performed after another 2 weeks. Treatment responses will be photo documented

Conditions

• Eczema

Interventions

Type	Name	Description
DEVICE	PSO-CT02 device	The PSO-CT02 device is worn on the affected skin area where it irradiates the target Eczema area for 30 minutes with blue light. A contralateral eczema area is left untreated and serves as control.

Timeline

• Start date: 2013-10-01
• Primary completion: 2014-03-01
• Completion: 2014-03-01
• First posted: 2013-12-06
• Last updated: 2015-07-20
• Results posted: 2015-07-20

Locations

1 site across 1 country: Germany