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
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
21
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.
Klinik for Dermatology and Allergology, medical faculty of the RWTH Aachen
Aachen, North Rhine-Westphalia, Germany
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)).
Time frame: at week 4
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)).
Time frame: 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.
Time frame: 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.
Time frame: 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)
Time frame: 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).
Time frame: week 6
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