PhototherapyNCT01818154
Validation of a New Hand Held Light Emitting Diode Device for the Determination of Minimal Erythema Dose (MED)
A study testing LED phototherapy and narrowband UVB phototherapy in people with Phototherapy, run by Henry Ford Health System at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 120 yearsHealthy volunteers can take part
- Conditions the study is for
- Phototherapy
- What is being tested?
- LED phototherapy and narrowband UVB phototherapy
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- May 2012to Dec 2013
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 120 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 1. Age greater than 18 years.
Who cannot join
- Pregnancy
- Lactation
- History of photosensitivity disorder
- Photosensitizing medications
- Personal history of melanoma or non-melanoma skin cancer.
- Skin disease on the back
Trial locations and contacts
1 site in 1 country.
United States1 site
Henry Ford Medical Center Department of Dermatology
Detroit, Michigan, 48202
About this study
Official title: 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.
- Conditions
- Phototherapy
- Being tested
- LED phototherapy, narrowband UVB phototherapy
- Keywords
- phototherapy, light emitting diode, minimal erythema dose, narrowband UVB
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LED phototherapyOther
narrowband UVB phototherapyOther
| Study group | Role | What they receive |
|---|---|---|
| Minimal Erythema Dose LED | Experimental | A 2 x 2 cm section of skin will be exposed to LED light. Receives: Other: LED phototherapy; Other: 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. Receives: Other: LED phototherapy; Other: narrowband UVB phototherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Mar 2013 (estimated)
- Study startMay 2012
- Primary completionDec 2013
- Study completionDec 2013
Why it stopped: study did not start
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PhototherapyStudies of the same condition, open and under way.
- More trials run by Henry Ford Health SystemThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Henry Ford Health System
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Iltefat Hamzavi, Henry Ford Health System
- Investigators
- Iltefat H Hamzavi, M.D., Principal investigator, Henry Ford Dermatology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01818154
- Sponsor's protocol ID
- 7257
- Status last verified
- Feb 2022
- First submitted
- 20 Mar 2013
- Last updated
- 2 Mar 2022
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Validation of a New Hand Held Light Emitting Diode (LED) Device for the Determination of Minimal Erythema Dose (MED) for Narrowband Ultraviolet B.
- ClinicalTrials.gov ID
- NCT01818154
- Acronym / sponsor ID
- 7257
- Conditions
- Phototherapy
- Keywords
- phototherapy, light emitting diode, minimal erythema dose, narrowband UVB
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: study did not start
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Henry Ford Health SystemUniversity, hospital or other
- Study start
- May 2012
- Primary completion
- Dec 2013 (actual)
- Study completion
- Dec 2013 (actual)
- First posted
- 26 Mar 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Minimal Erythema Dose LED | Experimental | Other: LED phototherapy, Other: narrowband UVB phototherapyA 2 x 2 cm section of skin will be exposed to LED light. |
| Minimal Erythema Dose narrow band UVB | Placebo comparator | Other: LED phototherapy, Other: narrowband UVB phototherapyA 2 x 2 cm section of skin will be exposed to narrow band UVB light. |
Who may qualify
- Ages
- 18 to 120 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 1. Age greater than 18 years.
Key exclusion criteria (6 listed)
- Pregnancy
- Lactation
- History of photosensitivity disorder
- Photosensitizing medications
- Personal history of melanoma or non-melanoma skin cancer.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| LED phototherapy | Other | Minimal Erythema Dose LED, Minimal Erythema Dose narrow band UVB |
| narrowband UVB phototherapy | Other | Minimal Erythema Dose LED, Minimal Erythema Dose narrow band UVB |
Primary outcome
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.
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Mar 2022.
Related trials for Phototherapy
RecruitingPhase 3
Outcomes of High-risk Non-muscle Invasive Bladder Cancer Treated With Blue Light Resection
Bladder Cancer
RecruitingPhase 1
A Study of JNJ-79635322 in Participants With Relapsed or Refractory Multiple Myeloma or Previously Treated Amyloid Light-chain (AL) Amyloidosis
Relapsed or Refractory Multiple Myeloma, Previously Treated Amyloid Light-chain (AL) Amyloidosis
RecruitingPhase 2
A Study to Evaluate the Efficacy and Safety of Belantamab Mafodotin in Combination With Cyclophosphamide, Bortezomib, and Dexamethasone in Adult Participants With Newly Diagnosed Amyloid Light Chain (AL) Amyloidosis
Amyloidosis
Active, not recruitingObservational study
Visual and Refractive Outcomes Following Stream Light Photorefractive Keratectomy (55μm Epithelial Removal) Versus Conventional Photorefractive Keratectomy
Photorefractive Keratectomy
Recruiting
Exploring The Effect of TikTok Trigger Warnings in a Clinical Sample of Youth at Risk of Suicide
Suicide Prevention, Social Media Users
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Iltefat H Hamzavi, M.D. principal investigator
Henry Ford Dermatology
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing LED phototherapy and narrowband UVB phototherapy in people with Phototherapy, run by Henry Ford Health System at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 2 Mar 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Minimal Erythema Dose (time frame: 1 day). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Mar 2022.