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Affect of Dose Rate on UVR Induced Skin Erythema

Sponsor
Goldenhersh, Michael, M.D. (Other)
Overall Status
Unknown status
CT.gov ID
NCT00785187
Collaborator
(none)
40
Enrollment

Study Details

Study Description

Brief 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)

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.

Condition or Disease Intervention/Treatment Phase
  • Device: exposure to UVB radiation
 N/A

Study Design

Study Type:
Interventional
Anticipated Enrollment :
40 participants
Allocation:
Randomized
Intervention Model:
Crossover Assignment
Masking:
None (Open Label)
Primary Purpose:
Basic Science
Official Title:
Randomized Open Crossover Study Researching Affect of Dose Rate on UVR Induced Skin Erythema
Study Start Date :
Dec 1, 2008
Anticipated Primary Completion Date :
Feb 1, 2009

Outcome Measures

Primary Outcome Measures

  1. 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 [end of study]

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 60 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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.

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

  • Goldenhersh, Michael, M.D.

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
, ,
ClinicalTrials.gov Identifier:
NCT00785187
Other Study ID Numbers:
  • goldenhersh1
First Posted:
Nov 5, 2008
Last Update Posted:
Nov 5, 2008
Last Verified:
Nov 1, 2008
Keywords provided by , ,
UVB induced skin erythema
Additional relevant MeSH terms:
Erythema

Study Results

No Results Posted as of Nov 5, 2008