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Blue Light for Treating Eczema

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Light and Health Venture
ClinicalTrials.gov Identifier:
NCT02002871
First received: December 2, 2013
Last updated: June 24, 2015
Last verified: June 2015
  Purpose
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

Condition Intervention
Eczema
Device: PSO-CT02 device

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by Light and Health Venture:

Primary Outcome Measures:
  • 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 Outcome Measures:
  • 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)).

  • 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.

  • 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.

  • 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)

  • 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 Outcome Measures:
  • Hyperpigmentation - Evaluation by Mexameter [ Time Frame: week 0, 2, 4, 6 ]
    Higher values describe a higher level of pigmentation.

  • Adverse Events (Serious and Non-serious) [ Time Frame: week 0, 2, 4, 6 ]
  • Adverse Device Events (Serious and Non-serious) [ Time Frame: over 6 weeks ]
  • 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.

  • Recovery of Hyperpigmentation During Follow up Period (Compared to Last Treatment) [ Time Frame: week 6 ]
    Higher values describe a higher level of pigmentation.

  • 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".


Enrollment: 21
Study Start Date: October 2013
Study Completion Date: March 2014
Primary Completion Date: March 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02002871

Locations
Germany
Klinik for Dermatology and Allergology, medical faculty of the RWTH Aachen
Aachen, NRW, Germany, 52074
Sponsors and Collaborators
Light and Health Venture
Investigators
Principal Investigator: Verena von Felbert, PD Dr. Klinik for Dermatology and Allergy, medical faculty of the RWTH Aachen
  More Information

Responsible Party: Light and Health Venture
ClinicalTrials.gov Identifier: NCT02002871     History of Changes
Other Study ID Numbers: EczemaCT01  CIV-13-08-011581 
Study First Received: December 2, 2013
Results First Received: March 16, 2015
Last Updated: June 24, 2015

Additional relevant MeSH terms:
Eczema
Dermatitis
Skin Diseases
Skin Diseases, Eczematous

ClinicalTrials.gov processed this record on February 20, 2017