A Sunscreen Based on Bioadhesive Nanoparticles
NCT02668536 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 13
Last updated 2018-03-13
Summary
The initial focus of the study will be on safety, sun protection factor (SPF) characterization, and substantivity (duration of protection) studies. The primary outcome of the study will be to measure the sun protection factor (SPF) of a bioadhesive nanoparticles (BNP) formulation in 20-25 healthy volunteers with fair skin.
Conditions
- Melanoma
- UV Ray Skin Damage
Interventions
- DRUG
-
Standard Sunscreen
Areas will be treated with a standard preparation, consisting of padimate O (7%) and oxybenzone (3%) will be used as the control sunscreen.
- DEVICE
-
BNP
Additional areas will be treated with empty bioadhesive nanoparticles (BNPs).
Sponsors & Collaborators
-
Yale University
lead OTHER
Principal Investigators
-
Michael Girardi, MD, FAAD · Yale University
-
Mark Saltzman, PhD · Yale University
Study Design
- Allocation
- NON_RANDOMIZED
- Purpose
- PREVENTION
- Masking
- DOUBLE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- Yes
Timeline & Regulatory
- Start
- 2017-07-17
- Primary Completion
- 2017-08-18
- Completion
- 2017-08-18
Countries
- United States
Study Locations
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