Blue Light for Treating Eczema

NCT02002871 | Completed Results

• 2 other identifiers: EczemaCT01CIV-13-08-011581
• Study Type: interventional
• Target: 21
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (5)

• 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

• Change From Baseline of Inflammation (Erythema) Evaluated by Mexameter of the Target Area as Compared to the Control Area

  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

  week 6

• Change From Baseline of Patient Rating of Itching of the Target Area as Compared to the Control Area

  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

  week 6

Other Outcomes (6)

• Hyperpigmentation - Evaluation by Mexameter

  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

Study Arms (2)

Blue light

EXPERIMENTAL

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

Device: PSO-CT02 device

Control

NO INTERVENTION

contralateral untreated control plaque on the same patient.

Interventions

PSO-CT02 device 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.

Blue light

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• \. 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Philips Electronics Nederland BV: lead

Study Sites (1)

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

Aachen, North Rhine-Westphalia, 52074, Germany

Location

MeSH Terms

Conditions

Eczema

Condition Hierarchy (Ancestors)

Dermatitis; Skin Diseases; Skin and Connective Tissue Diseases; Skin Diseases, Eczematous

Results Point of Contact

• Title: Prof. Dr. Matthias Born
• Organization: Philips GmbH Innovative Technologies Aachen

matthias.born@philips.com

+491735321764

Study Officials

• Verena von Felbert, PD Dr.

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

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 2, 2013
• First Posted: December 6, 2013
• Study Start: October 1, 2013
• Primary Completion: March 1, 2014
• Study Completion: March 1, 2014
• Last Updated: July 20, 2015
• Results First Posted: July 20, 2015

Record last verified: 2015-06

Locations

DE (1)