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WithdrawnNCT01818154Updated Mar 2, 2022

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

An interventional study of LED phototherapy and narrowband UVB phototherapy in Phototherapy, sponsored by Henry Ford Health System. Withdrawn at 1 site in United States. Open to participants aged 18 Years to 120 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2022-03-02.

Sponsored by Henry Ford Health System · Not applicable, Interventional, and Other

Why this study was withdrawn
study did not start
Phase
Not applicable
Study type
Interventional
Enrollment
0
Allocation
Non-randomized
Ages
18 Years to 120 Years
Sex
All
01

Study 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.

02

Conditions studied

  • Phototherapy

Keywords

  • phototherapy
  • light emitting diode
  • minimal erythema dose
  • narrowband UVB
03

In context

Lead sponsor

Henry Ford Health System is the lead sponsor of 303 studies on the registry; 50 are open to participants now.

Of its 37 completed or terminated interventional studies of FDA-regulated products, 24 (65%) have results posted.

Browse Henry Ford Health System studies →

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 120 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

1. Age greater than 18 years.

Exclusion criteria

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
05

Study design

Phase
Not applicable
Primary purpose
Other
Allocation
Non-randomized
Intervention model
Crossover assignment
Masking
None (open label)
Enrollment
0 participants (actual)

Study arms

  • 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

Interventions

  • OtherLED phototherapy
  • Othernarrowband UVB phototherapy
06

What researchers measure

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.

    Time frame: 1 day

07

Study locations

1 site
  • Henry Ford Medical Center Department of Dermatology
    Detroit, Michigan 48202, United States
08

Timeline

Tracking since Sep 25, 2026
Not marked actual or estimatedDates not marked actual or estimated

The record gives a start of May 2012, a primary completion of Dec 2013 and a completion of Dec 2013. It does not say whether these dates are actual or estimated.

How these figures are worked out, and which studies are left out of them.

Registered
Mar 20, 2013
First posted
Mar 26, 2013
Start
May 2012
Primary completionActual
Dec 2013
CompletionActual
Dec 2013
Last update
Mar 2, 2022
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Mar 2, 2022, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT01818154
Lead sponsor
Henry Ford Health System
Responsible party
Iltefat Hamzavi (Senior Staff Physician, Henry Ford Health System) — Principal investigator
First posted
Mar 26, 2013
Start date
May 2012
Primary completion
Dec 2013
Completion
Dec 2013
Last update
Mar 2, 2022

Study contacts

Iltefat H Hamzavi, M.D.
principal investigator · Henry Ford Dermatology

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is withdrawn, as verified in Feb 2022. You cannot join it, but the record below documents what was studied.

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