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

Not Applicable

Withdrawn

• Conditions: Phototherapy
• Interventions: Other: LED phototherapy; Other: narrowband UVB phototherapy

• Registration Number: NCT01818154
• Lead Sponsor: Henry Ford Health System

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2012-05
• Study First Submitted: 2013-03-20
• Study First Submitted QC: 2013-03-25
• Study First Posted: 2013-03-26
• Primary Completion: 2013-12
• Study Completion: 2013-12
• Status Verified: 2022-02
• Last Update Submitted: 2022-02-15
• Last Update Posted: 2022-03-02

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Minimal Erythema Dose LED	LED phototherapy	A 2 x 2 cm section of skin will be exposed to LED light.
Minimal Erythema Dose narrow band UVB	LED phototherapy	A 2 x 2 cm section of skin will be exposed to narrow band UVB light.
Minimal Erythema Dose narrow band UVB	narrowband UVB phototherapy	A 2 x 2 cm section of skin will be exposed to narrow band UVB light.
Minimal Erythema Dose LED	narrowband UVB phototherapy	A 2 x 2 cm section of skin will be exposed to LED light.

Primary Outcome Measures

Name	Time	Method
Minimal Erythema Dose	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.

Trial Locations

Locations (1)

Henry Ford Medical Center Department of Dermatology; 🇺🇸 Detroit, Michigan, United States