Clinical trial NCT02002871: 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
Overall status: COMPLETED
Phase: NA
Conditions: Eczema
Lead sponsor: Philips Electronics Nederland BV
Sponsor class: INDUSTRY
First posted: 2013-12-06
Enrollment: 21
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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


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

Primary outcomes:
measure: 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
timeFrame: at week 4
Secondary outcomes:
measure: Change From Week 4 of the Sum Score of Local Eczema Rating as Compared to the Control Area at End of Follow-up
timeFrame: week 6
measure: Change From Baseline of Inflammation (Erythema) Evaluated by Mexameter of the Target Area as Compared to the Control Area
timeFrame: week 4, 6
measure: 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
timeFrame: week 6
measure: Change From Baseline of Patient Rating of Itching of the Target Area as Compared to the Control Area
timeFrame: week 4, 6
measure: 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
timeFrame: week 6
Other outcomes:
measure: Hyperpigmentation - Evaluation by Mexameter
timeFrame: week 0, 2, 4, 6
measure: Adverse Events (Serious and Non-serious)
timeFrame: week 0, 2, 4, 6
measure: Adverse Device Events (Serious and Non-serious)
timeFrame: over 6 weeks
measure: Device Deficiencies
timeFrame: over 6 weeks
measure: Recovery of Hyperpigmentation During Follow up Period (Compared to Last Treatment)
timeFrame: week 6
measure: Number of Participants With Acceptance of Hyperpigmentation at Week 6
timeFrame: week 6
Locations:
city: Aachen
country: Germany
facility: Klinik for Dermatology and Allergology, medical faculty of the RWTH Aachen
state: NRW
Study officials:
affiliation: Klinik for Dermatology and Allergy, medical faculty of the RWTH Aachen
name: Verena von Felbert, PD Dr.
role: PRINCIPAL_INVESTIGATOR
References: