Blue Light for Treating Eczema

NCT ID: NCT02002871

Last Updated: 2015-07-20

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 21 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-10-31
• Study Completion Date: 2014-03-31

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

Conditions

Eczema

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Blue light

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

Group Type: EXPERIMENTAL

PSO-CT02 device

Intervention Type: 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.

Control

contralateral untreated control plaque on the same patient.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

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.

Intervention Type: DEVICE

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Philips Electronics Nederland BV

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Verena von Felbert, PD Dr.

Role: PRINCIPAL_INVESTIGATOR

Klinik for Dermatology and Allergy, medical faculty of the RWTH Aachen

Locations

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

Aachen, North Rhine-Westphalia, Germany

Countries

Germany

Other Identifiers

CIV-13-08-011581

Identifier Type: OTHER

Identifier Source: secondary_id

EczemaCT01

Identifier Type: -

Identifier Source: org_study_id