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

Conditions

• Epidermis
• Ultraviolet Exposure

Eligibility Criteria

Sex

ALL

Age

18 Years - 75 Years

Healthy Volunteers

Accepted

Interventions

• Hybrid sunscreen — DRUG
  Hybrid D II SPF 30
• Chemical sunscreen — DRUG
  Chemical SPF 30
• No sunscreen — OTHER
  No SPF Placebo

Study Details

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).

Key Dates

First listed

Aug 27, 2026

Start date

Sep 14, 2026

Status verified

Aug 2026

Primary completion

Feb 24, 2027

Completion

Apr 7, 2027

Study Design

Enrollment

60 participants (estimated)

Allocation

RANDOMIZED

Intervention model

SINGLE_GROUP

Primary purpose

BASIC_SCIENCE

Arms

• Placebo Comparator: No SPF Placebo
• Experimental: Test Product
• Active Comparator: Benchmark

Primary Outcome Measure

Chromameter [ Time Frame: Chromameter measurements will be obtained at Day 1 Baseline and Day 3 post treatment ]

Central Contacts

• Alexis Chantal, PA-C
  (336) 725-6501
  [email protected]

Locations (1)

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