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

NCT ID: NCT01818154

Last Updated: 2022-03-02

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Clinical Phase

NA

Study Classification

INTERVENTIONAL

Study Start Date

2012-05-31

Study Completion Date

2013-12-31

Brief Summary

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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.

Detailed Description

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Conditions

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Phototherapy

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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Minimal Erythema Dose LED

A 2 x 2 cm section of skin will be exposed to LED light.

Group Type EXPERIMENTAL

LED phototherapy

Intervention Type OTHER

narrowband UVB phototherapy

Intervention Type OTHER

Minimal Erythema Dose narrow band UVB

A 2 x 2 cm section of skin will be exposed to narrow band UVB light.

Group Type PLACEBO_COMPARATOR

LED phototherapy

Intervention Type OTHER

narrowband UVB phototherapy

Intervention Type OTHER

Interventions

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LED phototherapy

Intervention Type OTHER

narrowband UVB phototherapy

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

120 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Henry Ford Health System

OTHER

Sponsor Role lead

Responsible Party

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Iltefat Hamzavi

Senior Staff Physician

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Iltefat H Hamzavi, M.D.

Role: PRINCIPAL_INVESTIGATOR

Henry Ford Dermatology

Locations

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Henry Ford Medical Center Department of Dermatology

Detroit, Michigan, United States

Site Status

Countries

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United States

Other Identifiers

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7257

Identifier Type: -

Identifier Source: org_study_id

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