Clinical Trials Logo

Clinical Trial 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.


Clinical Trial 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. ;


Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Treatment


Related Conditions & MeSH terms


NCT number NCT02004847
Study type Interventional
Source Light and Health Venture
Contact
Status Completed
Phase N/A
Start date September 2013
Completion date May 2014

See also
  Status Clinical Trial Phase
Completed NCT03669757 - Clinical Trial to Assess Safety, Tolerability and the Pharmacodynamic Effect of Different Concentrations of a New Anti-inflammatory Substance in Subjects With Chronic Plaque Psoriasis Phase 1
Completed NCT03614078 - A Study of PRCL-02 in Moderate to Severe Chronic Plaque Psoriasis Phase 2
Completed NCT03584360 - Role of Topical Treatments in the Modulation of Skin Microbiome in Psoriatic Skin Phase 2
Recruiting NCT04994951 - Pilot Study of Traditional Chinese Medicine (Qing-Re-Liang-Xue Decoction) as Complementary Medicine for Psoriasis Vulgaris of Blood-heat Syndrome. Phase 2
Completed NCT02888236 - LEO 32731 for the Treatment of Moderate to Severe Psoriasis Vulgaris Phase 2
Completed NCT02533973 - Long-term Treatment of Scalp Psoriasis With Xamiol® Gel in a Large Adult Chinese Population Phase 4
Completed NCT02193815 - A 12 Day Study To Evaluate A Topical Drug To Treat Plaque Psoriasis Phase 1
Completed NCT01946386 - A Vasoconstriction Study With LEO 90100 Phase 1
Recruiting NCT01443338 - Study Evaluating the Efficacy and Safety of Triptergium Wilfordii and Acitretin in Psoriasis Vulgaris - CHINA201002016-2 Phase 4
Completed NCT01188928 - LEO 80185 in the Treatment of Psoriasis Vulgaris on the Non-scalp Regions of the Body (Trunk and/or Limbs) Phase 3
Completed NCT00764751 - Efficacy and Safety of LEO 19123 Cream in the Treatment of Psoriasis Vulgaris Phase 2
Completed NCT00236171 - Evaluation of Topical Antipsoriatics in the Psoriasis Plaque Test N/A
Recruiting NCT04541329 - Predicting Inflammatory Skin Disease Response to IL-23 Blockade Phase 4
Completed NCT06064084 - Incretin Effect in Patients With Psoriasis and Controls
Recruiting NCT05892640 - Low-Salt Diet Effect on Th17-Mediated Inflammation and Vascular Reactivity in Psoriasis N/A
Recruiting NCT05390515 - Psoriatic Immune Response to Tildrakizumab Phase 4
Recruiting NCT04950218 - The Psoriasis Echo Study
Completed NCT05184348 - Plexin B2 Gene Expression and Polymorphisms in Psoriasis Phase 1
Recruiting NCT04394936 - An Explorative Psoriasis Biomarker Study N/A
Completed NCT04343586 - Blue Light Phototherapy N/A