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RECRUITING
NCT07789639
PHASE4

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

Sponsor: Good Molecules, LLC

View on ClinicalTrials.gov

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).

Official title: 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

Key Details

Gender

All

Age Range

18 Years - 75 Years

Study Type

INTERVENTIONAL

Enrollment

60

Start Date

2026-09-14

Completion Date

2027-04-07

Last Updated

2026-08-27

Healthy Volunteers

Yes

Interventions

DRUG

Hybrid sunscreen

Hybrid D II SPF 30

DRUG

Chemical sunscreen

Chemical SPF 30

OTHER

No sunscreen

No SPF Placebo

Locations (1)

Eurofins | CRL, Cosmetics LLC

Winston-Salem, North Carolina, United States