Prospective, Randomized, Controlled, Partially Blinded, Skin Photobiological Clinical Study of the Efficacy and Safety of a Sunscreen Product as Skin Protector Against Porfimer Sodium-induced Phototoxicity to Visible Light
Human subjects with planned PDT course will be evaluated to confirm eligibility. Prior to
enrollment, all inclusion and exclusion criteria will be verified. Medical procedures
including demographic information (age, sex, race, smoking and drinking habits),
medical/surgical history, physical exam (including vital signs, body weight, height, and
skin color), clinical laboratory testing, concomitant medication intake and other therapy
uses will be collected. The study procedures will begin after the intravenous injection of
porfimer sodium.
Skin photobiological testing will consist of four 2-day periods performed over three months
after the injection of porfimer sodium at a dose of 2 mg/kg of body weight. Each period
will include a Skin Illumination session and a Skin Evaluation session. During the Skin
Illumination session, the Solar Protection Formula® SPF 60 will be randomly applied at a
dose of 2 mg/cm² on a skin subunit area of the back 30 minutes before illumination. A
second skin subunit will be used as a "no-treatment" observational area. Therefore, each
subject will be her/his own control. Illumination will be performed using a visible light
source. During the Skin Evaluation session, skin reactions will be scored by an outcome
assessor 24 hours after illumination according to a pre-determined rating scale. The
outcome assessor will be blinded to the active treatment sequence applications. All subjects
will be followed for three months.
Interventional
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Prevention
Skin erythema responses of control (unprotected) and Solar Protection Formula® SPF 60-protected sites to light exposure
Skin erythema responses will be scored 24 hours after photobiological testing
17 days
No
United States: Food and Drug Administration
MA-PO-PHOTB05-01
NCT01256203
May 2013
March 2014
Name | Location |
---|---|
Ohio State University | Columbus, Ohio 43210 |
St-Mary's Hospital (Mayo Clinic) | Rochester, Minnesota 55905 |