Blue Light for Treating Eczema

Eczema Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02002871
• Other study ID #: EczemaCT01
• Secondary ID: CIV-13-08-011581
• Status: Completed
• Phase: N/A
• First received: December 2, 2013
• Last updated: June 24, 2015
• Start date: October 2013
• Est. completion date: March 2014

Study information

• Verified date: June 2015
• Source: Light and Health Venture
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Ethics CommissionGermany: Federal Institute for Drugs and Medical Devices
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 21
• Est. completion date: March 2014
• Est. primary completion date: March 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 75 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Dermatitis
• Eczema

Intervention

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.

Locations

Country	Name	City	State
Germany	Klinik for Dermatology and Allergology, medical faculty of the RWTH Aachen	Aachen	NRW

Sponsors (1)

Lead Sponsor	Collaborator
Light and Health Venture

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Hyperpigmentation - Evaluation by Mexameter	Higher values describe a higher level of pigmentation.	week 0, 2, 4, 6	Yes
Other	Adverse Events (Serious and Non-serious)		week 0, 2, 4, 6	Yes
Other	Adverse Device Events (Serious and Non-serious)		over 6 weeks	Yes
Other	Device Deficiencies	This measure describes device deficiencies in general leading to a non functional device. No specific characteristics were assessed.	over 6 weeks	Yes
Other	Recovery of Hyperpigmentation During Follow up Period (Compared to Last Treatment)	Higher values describe a higher level of pigmentation.	week 6	Yes
Other	Number of Participants With Acceptance of Hyperpigmentation at Week 6	Questionaire if hyperpigmentation was acceptable if reported. Outcome was number of patients answering "yes" or "no".	week 6	Yes
Primary	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	No
Secondary	Change From Week 4 of the Sum Score of Local Eczema Rating as Compared to the Control Area at End of Follow-up	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)).	week 6	No
Secondary	Change From Baseline of Inflammation (Erythema) Evaluated by Mexameter of the Target Area as Compared to the Control Area	Higher values describe higher erythema levels.	week 4, 6	Yes
Secondary	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	Higher values describe a higher level of erythema.	week 6	Yes
Secondary	Change From Baseline of Patient Rating of Itching of the Target Area as Compared to the Control Area	patients were asked to rate itching on a VAS scale (1 no itching; 100 worst imaginable itching)	week 4, 6	No
Secondary	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	patients were asked to rate itching on a VAS scale (1 no itching; 100 worst imaginable itching).	week 6	No