Eczema
Conditions
Brief 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
Interventions
DEVICEPSO-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.
Sponsors
Philips Electronics Nederland BV
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
1. Signed and dated informed consent prior to any study-mandated procedure 2. Good health as determined by the Investigator according to physical examination 3. Willing and able to comply with study requirements 4. Skin type I-IV according to Fitzpatrick 5. Eczema, severity defined by an Eczema Area Severity Index (EASI)smaller/equal 20 6. 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
1. Inmates of psychiatric wards, prisons, or other state institutions 2. Investigator or any other team member involved in the conduct of the clinical study 3. Participation in another clinical trial within the last 30 days 4. Pregnant and lactating women 5. Photodermatosis and/or Photosensitivity 6. Porphyria and/or hypersensitivity to porphyrins 7. Congenital or acquired immunodeficiency 8. 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 9. Patients with genetic deficiencies attached with increased sensitivity to light or increased risk to dermatologic cancer (i.e. Xeroderma pigmentosum, Cockayne Syndrome, Bloom- Syndrome) 10. Current diagnosis of exfoliative or toxic dermatitis. 11. Evidence of superinfection of the intended treatment areas
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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 | at week 4 | 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)). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 | week 6 | patients were asked to rate itching on a VAS scale (1 no itching; 100 worst imaginable itching). |
| Change From Week 4 of the Sum Score of Local Eczema Rating as Compared to the Control Area at End of Follow-up | week 6 | 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)). |
| Change From Baseline of Inflammation (Erythema) Evaluated by Mexameter of the Target Area as Compared to the Control Area | week 4, 6 | Higher values describe higher erythema levels. |
| 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 | week 6 | Higher values describe a higher level of erythema. |
| Change From Baseline of Patient Rating of Itching of the Target Area as Compared to the Control Area | week 4, 6 | patients were asked to rate itching on a VAS scale (1 no itching; 100 worst imaginable itching) |
Other
| Measure | Time frame | Description |
|---|---|---|
| Adverse Events (Serious and Non-serious) | week 0, 2, 4, 6 | — |
| Hyperpigmentation - Evaluation by Mexameter | week 0, 2, 4, 6 | Higher values describe a higher level of pigmentation. |
| Adverse Device Events (Serious and Non-serious) | over 6 weeks | — |
| Device Deficiencies | over 6 weeks | This measure describes device deficiencies in general leading to a non functional device. No specific characteristics were assessed. |
| Recovery of Hyperpigmentation During Follow up Period (Compared to Last Treatment) | week 6 | Higher values describe a higher level of pigmentation. |
| Number of Participants With Acceptance of Hyperpigmentation at Week 6 | week 6 | Questionaire if hyperpigmentation was acceptable if reported. Outcome was number of patients answering yes or no. |
Countries
Germany
Participant flow
Recruitment details
Date of first enrollment: 23.10.2013, University Clinic Aachen Date of LPLV: 17.02.2014
Participants by arm
| Arm | Count |
|---|---|
| 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. | 21 |
| Total | 21 |
Baseline characteristics
| Characteristic | Blue Light vs Control |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 0 Participants |
| Age, Categorical Between 18 and 65 years | 21 Participants |
| Region of Enrollment Germany | 21 participants |
| Sex: Female, Male Female | 11 Participants |
| Sex: Female, Male Male | 10 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 0 / 20 |
| serious Total, serious adverse events | 0 / 20 |
Outcome results
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)).
Time frame: at week 4
Population: Overall number of participants is also 20 because control and treated plaque were anaylsed on the same patient.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Blue Light | 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 | -1.9 units on a scale | Standard Deviation 2.02 |
| Control | 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 | -1.3 units on a scale | Standard Deviation 2.24 |
Comparison: The statistical analysis was performed on the difference of the change from baseline of the Blue light treated plaque versus the Control plaque.p-value: 0.0152t-test, 2 sided
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.
Time frame: week 4, 6
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Blue Light | Change From Baseline of Inflammation (Erythema) Evaluated by Mexameter of the Target Area as Compared to the Control Area | week 4 | 4.7 arbitrary units | Standard Deviation 8.11 |
| Blue Light | Change From Baseline of Inflammation (Erythema) Evaluated by Mexameter of the Target Area as Compared to the Control Area | week 6 | 1.1 arbitrary units | Standard Deviation 7.74 |
| Control | Change From Baseline of Inflammation (Erythema) Evaluated by Mexameter of the Target Area as Compared to the Control Area | week 4 | -0.9 arbitrary units | Standard Deviation 10.28 |
| Control | Change From Baseline of Inflammation (Erythema) Evaluated by Mexameter of the Target Area as Compared to the Control Area | week 6 | 0.3 arbitrary units | Standard Deviation 7.36 |
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)
Time frame: week 4, 6
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Blue Light | Change From Baseline of Patient Rating of Itching of the Target Area as Compared to the Control Area | week 4 | -2.6 units on a scale | Standard Deviation 20.72 |
| Blue Light | Change From Baseline of Patient Rating of Itching of the Target Area as Compared to the Control Area | week 6 | -10.3 units on a scale | Standard Deviation 26.25 |
| Control | Change From Baseline of Patient Rating of Itching of the Target Area as Compared to the Control Area | week 4 | -15.6 units on a scale | Standard Deviation 23.85 |
| Control | Change From Baseline of Patient Rating of Itching of the Target Area as Compared to the Control Area | week 6 | -19.6 units on a scale | Standard Deviation 27.77 |
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.
Time frame: week 6
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Blue Light | 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 | -3.6 arbitrary units | Standard Deviation 9.38 |
| Control | 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 | 1.2 arbitrary units | Standard Deviation 8.04 |
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).
Time frame: week 6
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Blue Light | 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 | -7.7 units on a scale | Standard Deviation 14.11 |
| Control | 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 | -4.0 units on a scale | Standard Deviation 14.31 |
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)).
Time frame: week 6
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Blue Light | Change From Week 4 of the Sum Score of Local Eczema Rating as Compared to the Control Area at End of Follow-up | -0.5 units on a scale | Standard Deviation 1.54 |
| Control | Change From Week 4 of the Sum Score of Local Eczema Rating as Compared to the Control Area at End of Follow-up | -0.5 units on a scale | Standard Deviation 1.43 |
Other Pre-specified
Adverse Device Events (Serious and Non-serious)
Time frame: over 6 weeks
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Blue Light | Adverse Device Events (Serious and Non-serious) | 0 participants |
| Control | Adverse Device Events (Serious and Non-serious) | 0 participants |
Other Pre-specified
Adverse Events (Serious and Non-serious)
Time frame: week 0, 2, 4, 6
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Blue Light | Adverse Events (Serious and Non-serious) | week 4 | 0 participants |
| Blue Light | Adverse Events (Serious and Non-serious) | week 2 | 0 participants |
| Blue Light | Adverse Events (Serious and Non-serious) | week 6 | 0 participants |
| Blue Light | Adverse Events (Serious and Non-serious) | week 0 | 0 participants |
| Control | Adverse Events (Serious and Non-serious) | week 6 | 0 participants |
| Control | Adverse Events (Serious and Non-serious) | week 0 | 0 participants |
| Control | Adverse Events (Serious and Non-serious) | week 2 | 0 participants |
| Control | Adverse Events (Serious and Non-serious) | week 4 | 0 participants |
Other Pre-specified
Device Deficiencies
This measure describes device deficiencies in general leading to a non functional device. No specific characteristics were assessed.
Time frame: over 6 weeks
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Blue Light | Device Deficiencies | 0 participants |
| Control | Device Deficiencies | 0 participants |
Other Pre-specified
Hyperpigmentation - Evaluation by Mexameter
Higher values describe a higher level of pigmentation.
Time frame: week 0, 2, 4, 6
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Blue Light | Hyperpigmentation - Evaluation by Mexameter | week 0 | 27.8 arbitrary units | Standard Deviation 6.85 |
| Blue Light | Hyperpigmentation - Evaluation by Mexameter | week 6 | 26.5 arbitrary units | Standard Deviation 6.57 |
| Blue Light | Hyperpigmentation - Evaluation by Mexameter | week 2 | 26.3 arbitrary units | Standard Deviation 6.01 |
| Blue Light | Hyperpigmentation - Evaluation by Mexameter | week 4 | 25.6 arbitrary units | Standard Deviation 5.39 |
| Control | Hyperpigmentation - Evaluation by Mexameter | week 6 | 26.8 arbitrary units | Standard Deviation 5.51 |
| Control | Hyperpigmentation - Evaluation by Mexameter | week 4 | 28.4 arbitrary units | Standard Deviation 7.71 |
| Control | Hyperpigmentation - Evaluation by Mexameter | week 2 | 28.4 arbitrary units | Standard Deviation 6.04 |
| Control | Hyperpigmentation - Evaluation by Mexameter | week 0 | 28.0 arbitrary units | Standard Deviation 7.99 |
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.
Time frame: week 6
Population: 7 patients out of 20 patients reported hyperpigmentation at week 6.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Blue Light | Number of Participants With Acceptance of Hyperpigmentation at Week 6 | Yes | 6 participants |
| Blue Light | Number of Participants With Acceptance of Hyperpigmentation at Week 6 | No | 1 participants |
Other Pre-specified
Recovery of Hyperpigmentation During Follow up Period (Compared to Last Treatment)
Higher values describe a higher level of pigmentation.
Time frame: week 6
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Blue Light | Recovery of Hyperpigmentation During Follow up Period (Compared to Last Treatment) | 0.9 arbitrary units | Standard Deviation 5.78 |
| Control | Recovery of Hyperpigmentation During Follow up Period (Compared to Last Treatment) | -1.7 arbitrary units | Standard Deviation 6.49 |