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OpenTrials
Completed

NCT Number: NCT02002871

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. 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

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Key information

Conditions

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

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

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

Aachen, North Rhine-Westphalia, 52074, Germany

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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
  • 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

Treatment and study plan

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.

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

    Time frame: at week 4

    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 outcomes

  1. Change From Week 4 of the Sum Score of Local Eczema Rating as Compared to the Control Area at End of Follow-up

    Time frame: week 6

    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)).

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

    Time frame: week 4, 6

    Higher values describe higher erythema levels.

  3. 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

    Time frame: week 6

    Higher values describe a higher level of erythema.

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

    Time frame: week 4, 6

    patients were asked to rate itching on a VAS scale (1 no itching; 100 worst imaginable itching)

  5. 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

    Time frame: week 6

    patients were asked to rate itching on a VAS scale (1 no itching; 100 worst imaginable itching).

Other outcomes

  1. Hyperpigmentation - Evaluation by Mexameter

    Time frame: week 0, 2, 4, 6

    Higher values describe a higher level of pigmentation.

  2. Adverse Events (Serious and Non-serious)

    Time frame: week 0, 2, 4, 6

  3. Adverse Device Events (Serious and Non-serious)

    Time frame: over 6 weeks

  4. Device Deficiencies

    Time frame: over 6 weeks

    This measure describes device deficiencies in general leading to a non functional device. No specific characteristics were assessed.

  5. Recovery of Hyperpigmentation During Follow up Period (Compared to Last Treatment)

    Time frame: week 6

    Higher values describe a higher level of pigmentation.

  6. Number of Participants With Acceptance of Hyperpigmentation at Week 6

    Time frame: week 6

    Questionaire if hyperpigmentation was acceptable if reported. Outcome was number of patients answering "yes" or "no".

Sponsors and collaborators

Lead sponsor

Philips Electronics Nederland BV

Industry

Registry information

Official study title

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

Important dates

Study start
2013
Primary completion
2014
Study completion
2014
First posted
Dec 6, 2013
Registry last updated
Jul 20, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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