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NCT00785187 Clinical Trial

Affect of Dose Rate on UVR Induced Skin Erythema

Erythema Clinical Trial

Official title:
Randomized Open Crossover Study Researching Affect of Dose Rate on UVR Induced Skin Erythema

Clinical Trial Details — Status: Not yet recruiting

Administrative data
NCT number NCT00785187
Other study ID # goldenhersh1
Secondary ID
Status Not yet recruiting
Phase N/A
First received November 3, 2008
Last updated November 4, 2008
Start date December 2008

Study information
Verified date November 2008
Source Goldenhersh, Michael, M.D.
Contact n/a
Is FDA regulated No
Health authority Israel: Ministry of Health
Study type Interventional

Clinical 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)

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.

Recruitment information / eligibility
Status Not yet recruiting
Enrollment 40
Est. completion date
Est. primary completion date February 2009
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Both
Age group 18 Years to 60 Years
Eligibility 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.

Study Design

Allocation: Randomized, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Basic Science

Related Conditions & MeSH terms

Intervention

Device:
• exposure to UVB radiation
exposure to UVB radiation for limited time in order to establish subject's minimal erythema dose.

Locations
Country Name City State
n/a

Sponsors (1)
Lead Sponsor Collaborator
Goldenhersh, Michael, M.D.

Outcome
Type Measure Description Time frame Safety issue
Primary 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 Yes
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