Validation of a New Hand Held Light Emitting Diode Device for the Determination of Minimal Erythema Dose (MED)

February 15, 2022 updated by: Iltefat Hamzavi, Henry Ford Health System

Validation of a New Hand Held Light Emitting Diode (LED) Device for the Determination of Minimal Erythema Dose (MED) for Narrowband Ultraviolet B.

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.

Study Overview

Status

Withdrawn

Conditions

Intervention / Treatment

Study Type

Interventional

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Michigan
      • Detroit, Michigan, United States, 48202
        • Henry Ford Medical Center Department of Dermatology

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 120 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

1. Age greater than 18 years.

Exclusion Criteria:

  1. Pregnancy
  2. Lactation
  3. History of photosensitivity disorder
  4. Photosensitizing medications
  5. Personal history of melanoma or non-melanoma skin cancer.
  6. Skin disease on the back

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: OTHER
  • Allocation: NON_RANDOMIZED
  • Interventional Model: CROSSOVER
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Minimal Erythema Dose LED
A 2 x 2 cm section of skin will be exposed to LED light.
Other: LED phototherapy
Other: narrowband UVB phototherapy
PLACEBO_COMPARATOR: Minimal Erythema Dose narrow band UVB
A 2 x 2 cm section of skin will be exposed to narrow band UVB light.
Other: LED phototherapy
Other: narrowband UVB phototherapy

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Minimal Erythema Dose
Time Frame: 1 day
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.
1 day

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Henry Ford Health System

Investigators

  • Principal Investigator: Iltefat H Hamzavi, M.D., Henry Ford Dermatology

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2012

Primary Completion (ACTUAL)

December 1, 2013

Study Completion (ACTUAL)

December 1, 2013

Study Registration Dates

First Submitted

March 20, 2013

First Submitted That Met QC Criteria

March 25, 2013

First Posted (ESTIMATE)

March 26, 2013

Study Record Updates

Last Update Posted (ACTUAL)

March 2, 2022

Last Update Submitted That Met QC Criteria

February 15, 2022

Last Verified

February 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 7257

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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