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| ID | Type | Description | Link |
|---|---|---|---|
| CIV-13-08-011581 | Other Identifier | Unique identification number EUDAMED |
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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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Blue light | Experimental | Irradiation with PSOCT02 device emitting blue light at a wavelength of 453nm |
|
| Control | No Intervention | contralateral untreated control plaque on the same patient. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| PSO-CT02 device | 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. |
| 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 |
| 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)). |
| Measure | Description | Time Frame |
|---|---|---|
| Hyperpigmentation - Evaluation by Mexameter | Higher values describe a higher level of pigmentation. | week 0, 2, 4, 6 |
| Adverse Events (Serious and Non-serious) | week 0, 2, 4, 6 |
Inclusion Criteria:
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:
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| Name | Affiliation | Role |
|---|---|---|
| Verena von Felbert, PD Dr. | Klinik for Dermatology and Allergy, medical faculty of the RWTH Aachen | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Klinik for Dermatology and Allergology, medical faculty of the RWTH Aachen | Aachen | North Rhine-Westphalia | 52074 | Germany |
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Date of first enrollment: 23.10.2013, University Clinic Aachen Date of LPLV: 17.02.2014
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| ID | Title | Description |
|---|---|---|
| FG000 | Blue Light vs Control | Light wavelength 453nm, compared to contralateral untreated control plaque on the same patient. 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | Blue Light vs Control | Light wavelength 453nm, compared to contralateral untreated control plaque on the same patient. 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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)). | Overall number of participants is also 20 because control and treated plaque were anaylsed on the same patient. | Posted | Mean | Standard Deviation | units on a scale | at week 4 |
|
Adverse events were collected throughout the whole study period after the patients signed the informed consent untill the last follow up visit (week 0 to week 6)
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Blue Light vs Control | Light wavelength 453nm, compared to contralateral untreated control plaque on the same patient. 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. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Prof. Dr. Matthias Born | Philips GmbH Innovative Technologies Aachen | +491735321764 | matthias.born@philips.com |
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| ID | Term |
|---|---|
| D004485 | Eczema |
| ID | Term |
|---|---|
| D003872 | Dermatitis |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D017443 | Skin Diseases, Eczematous |
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| 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 |
| Adverse Device Events (Serious and Non-serious) | over 6 weeks |
| Device Deficiencies | This measure describes device deficiencies in general leading to a non functional device. No specific characteristics were assessed. | over 6 weeks |
| Recovery of Hyperpigmentation During Follow up Period (Compared to Last Treatment) | Higher values describe a higher level of pigmentation. | week 6 |
| Number of Participants With Acceptance of Hyperpigmentation at Week 6 | Questionaire if hyperpigmentation was acceptable if reported. Outcome was number of patients answering "yes" or "no". | week 6 |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| OG001 | Control | Contralateral untreated control plaque on the same patient. |
|
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| Secondary | 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)). | Posted | Mean | Standard Deviation | units on a scale | week 6 |
|
|
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| Secondary | 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. | Posted | Mean | Standard Deviation | arbitrary units | week 4, 6 |
|
|
|
| Secondary | 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. | Posted | Mean | Standard Deviation | arbitrary units | week 6 |
|
|
|
| Secondary | 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) | Posted | Mean | Standard Deviation | units on a scale | week 4, 6 |
|
|
|
| Secondary | 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). | Posted | Mean | Standard Deviation | units on a scale | week 6 |
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| Other Pre-specified | Hyperpigmentation - Evaluation by Mexameter | Higher values describe a higher level of pigmentation. | Posted | Mean | Standard Deviation | arbitrary units | week 0, 2, 4, 6 |
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| Other Pre-specified | Adverse Events (Serious and Non-serious) | Posted | Number | participants | week 0, 2, 4, 6 |
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| Other Pre-specified | Adverse Device Events (Serious and Non-serious) | Posted | Number | participants | over 6 weeks |
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| Other Pre-specified | Device Deficiencies | This measure describes device deficiencies in general leading to a non functional device. No specific characteristics were assessed. | Posted | Number | participants | over 6 weeks |
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| Other Pre-specified | Recovery of Hyperpigmentation During Follow up Period (Compared to Last Treatment) | Higher values describe a higher level of pigmentation. | Posted | Mean | Standard Deviation | arbitrary units | week 6 |
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| Other Pre-specified | Number of Participants With Acceptance of Hyperpigmentation at Week 6 | Questionaire if hyperpigmentation was acceptable if reported. Outcome was number of patients answering "yes" or "no". | 7 patients out of 20 patients reported hyperpigmentation at week 6. | Posted | Number | participants | week 6 |
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| 0 |
| 20 |
| 0 |
| 20 |
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| week 4 |
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| week 6 |
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| week 4 |
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| week 6 |
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