Affect of Dose Rate on UVR Induced Skin Erythema

Goldenhersh, Michael, M.D.40 enrolled

Overview

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

BASIC_SCIENCE

Masking

NONE

Enrollment

Conditions

Erythema

Interventions

exposure to UVB radiationDEVICE

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

Eligibility

Sex: ALLMin age: 18 YearsMax age: 60 YearsHealthy volunteers:

Medical Language ↔ Plain English

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.

Outcomes

Primary Outcomes

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

Data from ClinicalTrials.gov

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