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Trial record 14 of 838 for:    eczema

Blue Light for Treating Eczema

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ClinicalTrials.gov Identifier: NCT02002871
Recruitment Status : Completed
First Posted : December 6, 2013
Results First Posted : July 20, 2015
Last Update Posted : July 20, 2015
Sponsor:
Information provided by (Responsible Party):
Philips Light and Health

Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition: Eczema
Intervention: Device: PSO-CT02 device

  Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
Date of first enrollment: 23.10.2013, University Clinic Aachen Date of LPLV: 17.02.2014

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
Blue Light vs Control

Light wavelength 453nm, compared to contralateral untreated control plaque on the same patient.

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.


Participant Flow:   Overall Study
    Blue Light vs Control
STARTED   21 
COMPLETED   20 
NOT COMPLETED   1 



  Baseline Characteristics

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
Blue Light vs Control

Light wavelength 453nm, compared to contralateral untreated control plaque on the same patient.

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.


Baseline Measures
   Blue Light vs Control 
Overall Participants Analyzed 
[Units: Participants]
 21 
Age 
[Units: Participants]
 
<=18 years   0 
Between 18 and 65 years   21 
>=65 years   0 
Gender 
[Units: Participants]
 
Female   11 
Male   10 
Region of Enrollment 
[Units: Participants]
 
Germany   21 


  Outcome Measures

1.  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   [ Time Frame: at week 4 ]

2.  Secondary:   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 ]

3.  Secondary:   Change From Baseline of Inflammation (Erythema) Evaluated by Mexameter of the Target Area as Compared to the Control Area   [ Time Frame: week 4, 6 ]

4.  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   [ Time Frame: week 6 ]

5.  Secondary:   Change From Baseline of Patient Rating of Itching of the Target Area as Compared to the Control Area   [ Time Frame: week 4, 6 ]

6.  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   [ Time Frame: week 6 ]

7.  Other Pre-specified:   Hyperpigmentation – Evaluation by Mexameter   [ Time Frame: week 0, 2, 4, 6 ]

8.  Other Pre-specified:   Adverse Events (Serious and Non-serious)   [ Time Frame: week 0, 2, 4, 6 ]

9.  Other Pre-specified:   Adverse Device Events (Serious and Non-serious)   [ Time Frame: over 6 weeks ]

10.  Other Pre-specified:   Device Deficiencies   [ Time Frame: over 6 weeks ]

11.  Other Pre-specified:   Recovery of Hyperpigmentation During Follow up Period (Compared to Last Treatment)   [ Time Frame: week 6 ]

12.  Other Pre-specified:   Number of Participants With Acceptance of Hyperpigmentation at Week 6   [ Time Frame: week 6 ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
No text entered.


  More Information

Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.


Results Point of Contact:  
Name/Title: Prof. Dr. Matthias Born
Organization: Philips GmbH Innovative Technologies Aachen
phone: +491735321764
e-mail: matthias.born@philips.com



Responsible Party: Philips Light and Health
ClinicalTrials.gov Identifier: NCT02002871     History of Changes
Other Study ID Numbers: EczemaCT01
CIV-13-08-011581 ( Other Identifier: Unique identification number EUDAMED )
First Submitted: December 2, 2013
First Posted: December 6, 2013
Results First Submitted: March 16, 2015
Results First Posted: July 20, 2015
Last Update Posted: July 20, 2015