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Blue Light for Treating Eczema

Primary Purpose

Eczema

Status
Completed
Phase
Not Applicable
Locations
Germany
Study Type
Interventional
Intervention
PSO-CT02 device
Sponsored by
Philips Electronics Nederland BV
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Eczema

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Klinik for Dermatology and Allergology, medical faculty of the RWTH Aachen

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Blue light

Control

Arm Description

Irradiation with PSOCT02 device emitting blue light at a wavelength of 453nm

contralateral untreated control plaque on the same patient.

Outcomes

Primary Outcome Measures

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)).

Secondary Outcome Measures

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)).
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.
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.
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)
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).

Full Information

First Posted
December 2, 2013
Last Updated
June 24, 2015
Sponsor
Philips Electronics Nederland BV
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1. Study Identification

Unique Protocol Identification Number
NCT02002871
Brief Title
Blue Light for Treating Eczema
Official Title
Monocenter, Randomized, Intraindividual, Open Label, Exploratory Study Comparing 4 Weeks of Treatment With 453nm Blue Light With no Treatment in Patients With Eczema
Study Type
Interventional

2. Study Status

Record Verification Date
June 2015
Overall Recruitment Status
Completed
Study Start Date
October 2013 (undefined)
Primary Completion Date
March 2014 (Actual)
Study Completion Date
March 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Philips Electronics Nederland BV

4. Oversight

Data Monitoring Committee
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Eczema

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
21 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Blue light
Arm Type
Experimental
Arm Description
Irradiation with PSOCT02 device emitting blue light at a wavelength of 453nm
Arm Title
Control
Arm Type
No Intervention
Arm Description
contralateral untreated control plaque on the same patient.
Intervention Type
Device
Intervention Name(s)
PSO-CT02 device
Intervention Description
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.
Primary Outcome Measure Information:
Title
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
Description
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
Secondary Outcome Measure Information:
Title
Change From Week 4 of the Sum Score of Local Eczema Rating as Compared to the Control Area at End of Follow-up
Description
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
Title
Change From Baseline of Inflammation (Erythema) Evaluated by Mexameter of the Target Area as Compared to the Control Area
Description
Higher values describe higher erythema levels.
Time Frame
week 4, 6
Title
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
Description
Higher values describe a higher level of erythema.
Time Frame
week 6
Title
Change From Baseline of Patient Rating of Itching of the Target Area as Compared to the Control Area
Description
patients were asked to rate itching on a VAS scale (1 no itching; 100 worst imaginable itching)
Time Frame
week 4, 6
Title
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
Description
patients were asked to rate itching on a VAS scale (1 no itching; 100 worst imaginable itching).
Time Frame
week 6
Other Pre-specified Outcome Measures:
Title
Hyperpigmentation - Evaluation by Mexameter
Description
Higher values describe a higher level of pigmentation.
Time Frame
week 0, 2, 4, 6
Title
Adverse Events (Serious and Non-serious)
Time Frame
week 0, 2, 4, 6
Title
Adverse Device Events (Serious and Non-serious)
Time Frame
over 6 weeks
Title
Device Deficiencies
Description
This measure describes device deficiencies in general leading to a non functional device. No specific characteristics were assessed.
Time Frame
over 6 weeks
Title
Recovery of Hyperpigmentation During Follow up Period (Compared to Last Treatment)
Description
Higher values describe a higher level of pigmentation.
Time Frame
week 6
Title
Number of Participants With Acceptance of Hyperpigmentation at Week 6
Description
Questionaire if hyperpigmentation was acceptable if reported. Outcome was number of patients answering "yes" or "no".
Time Frame
week 6

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Verena von Felbert, PD Dr.
Organizational Affiliation
Klinik for Dermatology and Allergy, medical faculty of the RWTH Aachen
Official's Role
Principal Investigator
Facility Information:
Facility Name
Klinik for Dermatology and Allergology, medical faculty of the RWTH Aachen
City
Aachen
State/Province
NRW
ZIP/Postal Code
52074
Country
Germany

12. IPD Sharing Statement

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Blue Light for Treating Eczema

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