Erythema | Affect of Dose Rate on UVR Induced Skin Erythema
Erythema research study
What is the primary objective of this study?
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.
Who is eligible to participate?
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.
Which medical condition, disease, disorder, syndrome, illness, or injury is researched?
Interventions can include giving participants drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available or noninvasive approaches such as surveys, education, and interviews.
Device:exposure to UVB radiationexposure to UVB radiation for limited time in order to establish subject's minimal erythema dose.
Research studies and clinical trials typically have two or more research arms. An arm is a group of people who receive the same treatment in the study.
Start Date: December 2008
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
Study sponsors, principal investigator, and references
Lead Sponsor: Goldenhersh, Michael, M.D.