Back to resultsValidation of a New Hand Held Light Emitting Diode Device for the Determination of Minimal Erythema Dose (MED)
Primary Purpose
Phototherapy
Status
Withdrawn
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
LED phototherapy
narrowband UVB phototherapy
Sponsored by
About this trial
This is an interventional other trial for Phototherapy focused on measuring phototherapy, light emitting diode, minimal erythema dose, narrowband UVB
Eligibility Criteria
Inclusion Criteria:
1. Age greater than 18 years.
Exclusion Criteria:
- Pregnancy
- Lactation
- History of photosensitivity disorder
- Photosensitizing medications
- Personal history of melanoma or non-melanoma skin cancer.
- Skin disease on the back
Sites / Locations
- Henry Ford Medical Center Department of Dermatology
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
Minimal Erythema Dose LED
Minimal Erythema Dose narrow band UVB
Arm Description
A 2 x 2 cm section of skin will be exposed to LED light.
A 2 x 2 cm section of skin will be exposed to narrow band UVB light.
Outcomes
Primary Outcome Measures
Minimal Erythema Dose
The Investigator will look at area irradiated and evaluate for erythema. The lowest dose at which erythema is noted will be recorded as the minimal erythema dose.
Secondary Outcome Measures
Full Information
NCT ID
NCT01818154
First Posted
March 20, 2013
Last Updated
February 15, 2022
Sponsor
Henry Ford Health System
1. Study Identification
Unique Protocol Identification Number
NCT01818154
Brief Title
Validation of a New Hand Held Light Emitting Diode Device for the Determination of Minimal Erythema Dose (MED)
Official Title
Validation of a New Hand Held Light Emitting Diode (LED) Device for the Determination of Minimal Erythema Dose (MED) for Narrowband Ultraviolet B.
Study Type
Interventional
2. Study Status
Record Verification Date
February 2022
Overall Recruitment Status
Withdrawn
Why Stopped
study did not start
Study Start Date
May 2012 (undefined)
Primary Completion Date
December 2013 (Actual)
Study Completion Date
December 2013 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Henry Ford Health System
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
The purpose of this study is to validate a new hand held light emitting diode (LED) device for the measurement of minimal erythema dose (MED) for narrow band Ultraviolet B (UVB) radiation by comparing to the traditional approach of measurement of the minimal erythema dose.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Phototherapy
Keywords
phototherapy, light emitting diode, minimal erythema dose, narrowband UVB
7. Study Design
Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
0 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Minimal Erythema Dose LED
Arm Type
Experimental
Arm Description
A 2 x 2 cm section of skin will be exposed to LED light.
Arm Title
Minimal Erythema Dose narrow band UVB
Arm Type
Placebo Comparator
Arm Description
A 2 x 2 cm section of skin will be exposed to narrow band UVB light.
Intervention Type
Other
Intervention Name(s)
LED phototherapy
Intervention Type
Other
Intervention Name(s)
narrowband UVB phototherapy
Primary Outcome Measure Information:
Title
Minimal Erythema Dose
Description
The Investigator will look at area irradiated and evaluate for erythema. The lowest dose at which erythema is noted will be recorded as the minimal erythema dose.
Time Frame
1 day
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
120 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
1. Age greater than 18 years.
Exclusion Criteria:
Pregnancy
Lactation
History of photosensitivity disorder
Photosensitizing medications
Personal history of melanoma or non-melanoma skin cancer.
Skin disease on the back
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Iltefat H Hamzavi, M.D.
Organizational Affiliation
Henry Ford Dermatology
Official's Role
Principal Investigator
Facility Information:
Facility Name
Henry Ford Medical Center Department of Dermatology
City
Detroit
State/Province
Michigan
ZIP/Postal Code
48202
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Validation of a New Hand Held Light Emitting Diode Device for the Determination of Minimal Erythema Dose (MED)
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