A Clinical Study to Evaluate the Interstitial Dermal Fluid, Efficacy and Sun Protection Factor (SPF) of Two Test Materials According to an Adaptation of the Guidelines of the FDA Over-the-Counter Monograph M020: Sunscreen Drug Products for Over-the-Counter Human Use

Summary

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).

Eligibility

Age range

18–75 years

Sex

All

Healthy volunteers

Yes

Interventions

• Drug
  Hybrid sunscreen

  Hybrid D II SPF 30

• Drug
  Chemical sunscreen

  Chemical SPF 30

• Other
  No sunscreen

  No SPF Placebo

Location