NCT01818154

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.

Trial Health

30
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Timeline
Completed

Started May 2012

Geographic Reach
1 country

1 active site

Status
withdrawn

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2012

Completed
11 months until next milestone

First Submitted

Initial submission to the registry

March 20, 2013

Completed
6 days until next milestone

First Posted

Study publicly available on registry

March 26, 2013

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2013

Completed
Last Updated

March 2, 2022

Status Verified

February 1, 2022

Enrollment Period

1.6 years

First QC Date

March 20, 2013

Last Update Submit

February 15, 2022

Conditions

Phototherapy

Keywords

phototherapylight emitting diodeminimal erythema dosenarrowband UVB

Outcome Measures

Primary Outcomes (1)

  • 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.

    1 day

Study Arms (2)

Minimal Erythema Dose LED

EXPERIMENTAL

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

Other: LED phototherapyOther: narrowband UVB phototherapy

Minimal Erythema Dose narrow band UVB

PLACEBO COMPARATOR

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

Other: LED phototherapyOther: narrowband UVB phototherapy

Interventions

LED phototherapyOTHER
Minimal Erythema Dose LEDMinimal Erythema Dose narrow band UVB
narrowband UVB phototherapyOTHER
Minimal Erythema Dose LEDMinimal Erythema Dose narrow band UVB

Eligibility Criteria

Age18 Years - 120 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • \. Age greater than 18 years.

You may not qualify if:

  • Pregnancy
  • Lactation
  • History of photosensitivity disorder
  • Photosensitizing medications
  • Personal history of melanoma or non-melanoma skin cancer.
  • Skin disease on the back

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Henry Ford Medical Center Department of Dermatology

Detroit, Michigan, 48202, United States

Location

Study Officials

  • Iltefat H Hamzavi, M.D.

    Henry Ford Dermatology

    PRINCIPAL INVESTIGATOR
0

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
OTHER
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Senior Staff Physician

Study Record Dates

First Submitted

March 20, 2013

First Posted

March 26, 2013

Study Start

May 1, 2012

Primary Completion

December 1, 2013

Study Completion

December 1, 2013

Last Updated

March 2, 2022

Record last verified: 2022-02

Locations

US(1)