A Clinical Study to Evaluate the Efficacy and SPF of Two Test Materials According to an Adaptation of the Guidelines of the FDA Sunscreen Drug Products for Over-the-Counter Human Use
Approximately 70 subjects (35 subjects per light and dark group) will be enrolled in this clinical study (to complete with a minimum of 10 subjects per skin type (I-VI) to assess the effects of known UV Radiation dosage on light and dark skin, assess the protective effect of two SPF test materials, placebo product, and standard sunscreen ('Pad O') on skin, before and after a known UV Radiation dosage and collect the interstitial dermal fluid from approximately 60 subjects and send to Eurofins Discovery for analysis. The following study evaluations will be obtained: SPF Determination, Visual Assessment of Erythema, Chromameter and Mexameter measurements, Digital photography, Thermometer readings and Collection of Dermal Interstitial Fluid (IDF).
Subject is male or female between 18 - 75 years old, providing legally effective... [+13]
Female subject is pregnant, nursing, planning a pregnancy, or using inadequate b... [+16]