Affect of Dose Rate on UVR Induced Skin Erythema

NCT ID: NCT00785187

Last Updated: 2008-11-05

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-12-31

Brief Summary

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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.

Detailed Description

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Conditions

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Erythema

Keywords

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UVB induced skin erythema

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

NONE

Interventions

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exposure to UVB radiation

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

Intervention Type DEVICE

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Goldenhersh, Michael, M.D.

INDIV

Sponsor Role lead

Responsible Party

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Dr. Goldenhersh's Dermatology Clinic

Other Identifiers

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goldenhersh1

Identifier Type: -

Identifier Source: org_study_id