ErythemaNCT00785187
Affect of Dose Rate on UVR Induced Skin Erythema
A study testing exposure to UVB radiation in people with Erythema, run by Goldenhersh, Michael, M.D..
Trial summary
Purpose of study: Evaluation of the affect of dose rate on UVR induced skin erythema. Study design: A single-center, prospective, randomized, crossover, open study. Number of patients: 20-40 Patient population: Healthy volunteers Control: Different sites on patients body Procedure duration: Total 3-5 hours (4 visits)… Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Erythema
- What is being tested?
- exposure to UVB radiation
- Type of treatment
- Medical device
- How many people
- 40 participants
- Where
- No sites listed yet
- Study dates
- Dec 2008to Feb 2009
- 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 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Fitzpatrick Skin types I-III.
- Age 18-60.
- Absence of obvious sun damage on the volar side of the forearm or other exposure sites.
- Absence of exposure of the arms or other exposure sites to sunlight for two weeks prior to the experiment.
Who cannot join
- History of skin cancer.
- Multiple nevi or atypical nevi on the forearm.
- Signs of sun damage on the volar side of the forearm or other exposure sites.
- Mentally incompetent.
About this study
Official title: Randomized Open Crossover Study Researching Affect of Dose Rate on UVR Induced Skin Erythema
Purpose of study: Evaluation of the affect of dose rate on UVR induced skin erythema.
Study design: A single-center, prospective, randomized, crossover, open study.
Number of patients: 20-40
Patient population: Healthy volunteers
Control: Different sites on patients body
Procedure duration: Total 3-5 hours (4 visits)
Duration of follow up: 4 days
Duration of study: Up to 6 months
Primary objectives: To examine the difference in erythemal response as a function of dose rate, and to assess the total amount of energy that is theoretically transmitted through a sunscreen within the range of SPF 2-10.
- Conditions
- Erythema
- Being tested
- exposure to UVB radiation
- Keywords
- UVB induced skin erythema
- Medical subject headings
- Erythema
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
exposure to UVB radiationDevice
exposure to UVB radiation for limited time in order to establish subject's minimal erythema dose.
What is being measured
The primary outcome is the main question the study is designed to answer.
To examine the difference in erythemal response as a function of dose rate, and to assess the total amount of energy that is theoretically transmitted through a sunscreen within the range of SPF 2-10
Measured: end of study
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Nov 2008 (estimated)
- Study startDec 2008
- Primary completionFeb 2009 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ErythemaStudies of the same condition, open and under way.
- 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
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Goldenhersh, Michael, M.D.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00785187
- Sponsor's protocol ID
- goldenhersh1
- Status last verified
- Nov 2008
- First submitted
- 3 Nov 2008
- Last updated
- 5 Nov 2008
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Nov 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Open Crossover Study Researching Affect of Dose Rate on UVR Induced Skin Erythema
- ClinicalTrials.gov ID
- NCT00785187
- Acronym / sponsor ID
- goldenhersh1
- Conditions
- Erythema
- Keywords
- UVB induced skin erythema
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Goldenhersh, Michael, M.D.
- Study start
- Dec 2008
- Primary completion
- Feb 2009 (estimated)
- First posted
- 5 Nov 2008 (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.
Purpose of study: Evaluation of the affect of dose rate on UVR induced skin erythema.
Study design: A single-center, prospective, randomized, crossover, open study.
Number of patients: 20-40
Patient population: Healthy volunteers
Control: Different sites on patients body
Procedure duration: Total 3-5 hours (4 visits)
Duration of follow up: 4 days
Duration of study: Up to 6 months
Primary objectives: To examine the difference in erythemal response as a function of dose rate, and to assess the total amount of energy that is theoretically transmitted through a sunscreen within the range of SPF 2-10.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Fitzpatrick Skin types I-III.
- Age 18-60.
- Absence of obvious sun damage on the volar side of the forearm or other exposure sites.
- Absence of exposure of the arms or other exposure sites to sunlight for two weeks prior to the experiment.
Key exclusion criteria (4 listed)
- History of skin cancer.
- Multiple nevi or atypical nevi on the forearm.
- Signs of sun damage on the volar side of the forearm or other exposure sites.
- Mentally incompetent.
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 |
|---|---|---|
| exposure to UVB radiationexposure to UVB radiation for limited time in order to establish subject's minimal erythema dose. | Device | – |
Primary outcome
To examine the difference in erythemal response as a function of dose rate, and to assess the total amount of energy that is theoretically transmitted through a sunscreen within the range of SPF 2-10
Time frame: end of study
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Nov 2008.
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing exposure to UVB radiation in people with Erythema, run by Goldenhersh, Michael, M.D..
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 4 inclusion and 4 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: status not confirmed, as of the sponsor's last update on 5 Nov 2008. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. 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?
Results are not available in the source record.
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?
To examine the difference in erythemal response as a function of dose rate, and to assess the total amount of energy that is theoretically transmitted through a sunscreen within the range of SPF 2-10 (time frame: end of study). 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 5 Nov 2008.