Blue Light for Treating Eczema

Study Overview
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Brief Summary
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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

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

Conditions
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Eczema

Intervention / Treatment
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* Device: PSO-CT02 device


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Signed and dated informed consent prior to any study-mandated procedure Good health as determined by the Investigator according to physical examination Willing and able to comply with study requirements Skin type I-IV according to Fitzpatrick Eczema, severity defined by an Eczema Area Severity Index (EASI)smaller/equal 20 Comparable clinical symptomatology of both intended treatment Areas 8. Reliable method of contraception for women of childbearing potential (i.e. low failure rate less than 1% per year; e.g. oral contraceptives, intrauterine device [IUD] or transdermal contraceptive patch) 9. Willing to abstain from excessive sun / UV exposure (e.g. sunbathe, solarium) during the course of the study Exclusion Criteria: Inmates of psychiatric wards, prisons, or other state institutions Investigator or any other team member involved in the conduct of the clinical study Participation in another clinical trial within the last 30 days Pregnant and lactating women Photodermatosis and/or Photosensitivity Porphyria and/or hypersensitivity to porphyrins Congenital or acquired immunodeficiency Patients with any of the following conditions present on the study areas; Malignoma of the skin or severe actinic damage of the skin, atypical naevi or signs of hyperpigmentation, precancerosis viral (e.g. herpes or varicella) lesions of the skin, fungal and bacterial skin infections, parasitic infections and atrophic skin Patients with genetic deficiencies attached with increased sensitivity to light or increased risk to dermatologic cancer (i.e. Xeroderma pigmentosum, Cockayne Syndrome, Bloom- Syndrome) Current diagnosis of exfoliative or toxic dermatitis. Evidence of superinfection of the intended treatment areas

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Blue light<br>Irradiation with PSOCT02 device emitting blue light at a wavelength of 453nm | Device: PSO-CT02 device<br>* 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.<br>|
| No Intervention: Control<br>contralateral untreated control plaque on the same patient. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change From Baseline (Visit 2) of the Sum Score of Local Eczema Rating of the Target Area as Compared to the Control Area at End of Treatment | The investigator rated the key symptoms erythema, induration/papulation/edema, excoriation, lichenification and crusts on a score of 0-3 (none, mild, moderate, and severe) with half steps allowed. A total severity score was calculated as the sum of the single symptom ratings (range 0-15 whereas 0 (best) - 15 (worst)). | at week 4 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change From Week 4 of the Sum Score of Local Eczema Rating as Compared to the Control Area at End of Follow-up | The investigator rated the key symptoms erythema, induration/papulation/edema, excoriation, lichenification and crusts on a score of 0-3 (none, mild, moderate, and severe) with half steps allowed. A total severity score was calculated as the sum of the single symptom ratings (range 0-15 whereas 0 (best) - 15 (worst)). | week 6 | 
| Change From Baseline of Inflammation (Erythema) Evaluated by Mexameter of the Target Area as Compared to the Control Area | Higher values describe higher erythema levels. | week 4, 6 | 
| Change From Week 4 (End of Treatment) of Inflammation (Erythema) Evaluated by Mexameter of the Target Area as Compared to the Control Area at End of Follow-up | Higher values describe a higher level of erythema. | week 6 | 
| Change From Baseline of Patient Rating of Itching of the Target Area as Compared to the Control Area | patients were asked to rate itching on a VAS scale (1 no itching; 100 worst imaginable itching) | week 4, 6 | 
| Change From Week 4 (End of Treatment) of Patient Rating of Itching of the Target Area as Compared to the Control Area at End of Follow-up | patients were asked to rate itching on a VAS scale (1 no itching; 100 worst imaginable itching). | week 6 |