Blue Light for Treating Eczema

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

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 Overview

• Status: Completed
• Conditions: Eczema
• Intervention / Treatment: Device: PSO-CT02 device

• Study Type: Interventional
• Enrollment (Actual): 21
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Germany
  • NRW
    • Aachen, NRW, Germany, 52074
      • Klinik for Dermatology and Allergology, medical faculty of the RWTH Aachen

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Blue light; Irradiation with PSOCT02 device emitting blue light at a wavelength of 453nm	Device: 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.
No Intervention: Control; contralateral untreated control plaque on the same patient.

What is the study measuring?

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

Other Outcome Measures

Outcome Measure	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
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

Collaborators and Investigators

• Sponsor: Philips Electronics Nederland BV
• Investigators: Principal Investigator: Verena von Felbert, PD Dr., Klinik for Dermatology and Allergy, medical faculty of the RWTH Aachen

Study record dates

Study Major Dates

• Study Start: October 1, 2013
• Primary Completion (Actual): March 1, 2014
• Study Completion (Actual): March 1, 2014

Study Registration Dates

• First Submitted: December 2, 2013
• First Submitted That Met QC Criteria: December 2, 2013
• First Posted (Estimate): December 6, 2013

Study Record Updates

• Last Update Posted (Estimate): July 20, 2015
• Last Update Submitted That Met QC Criteria: June 24, 2015
• Last Verified: June 1, 2015

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Skin Diseases; Dermatitis; Skin Diseases, Eczematous; Eczema
• Other Study ID Numbers: EczemaCT01; CIV-13-08-011581 (Other Identifier: Unique identification number EUDAMED)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No