Neoplasms

Skin and Connective Tissue Diseases

All Conditions

Rare Diseases

Melanoma

Neuroendocrine Tumors

Neuroectodermal Tumors

Neuroectodermal Tumors, Primitive

Neoplasms, Germ Cell and Embryonal

Neoplasms by Histologic Type

Neoplasms, Nerve Tissue

Nevus, Pigmented

Nevus

Nevi and Melanomas

Skin Neoplasms

Skin Diseases

Neuroendocrine Tumor

Neuroepithelioma

Dermatologic Agents

All Drugs and Chemicals

Sunscreening Agents

Oxybenzone

Protective Agents

Radiation-Protective Agents

A UV filtering agent and bioadhesive nanoparticles (BNPs) will comprise the experimental condition in this study. Participants will have 5 sites on their torso where they will have these placed.

A placebo bioadhesive nanoparticles (BNPs) (strips with no UV filtering) will comprise the sham comparison in this study. Participants will have 5 sites on their torso where they will have these placed.

As the active comparator, participants will have 5 sites on their torso where they will have standard sunscreen applied.

Participants will have 5 sites on their torso where no agent will be applied.

Areas will be treated with a standard preparation, consisting of padimate O (7%) and oxybenzone (3%) will be used as the control sunscreen.

Standard Sunscreen

Additional areas will be treated with empty bioadhesive nanoparticles (BNPs).

Michael Girardi, MD, FAAD

Mark Saltzman, PhD

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.

The purpose of this study will be to evaluate the duration of protection and efficacy of a novel bioadhesive nanoparticle sunscreen in 20-25 human volunteers.This technology makes sunscreens safer and longer-lasting by encapsulating UV sunscreen active agents in non-toxic nanoparticles. Strong preclinical data exists demonstrating the potential for improved safety, long-duration of retention, and increased effectiveness of this product.

This innovative solution focuses on preventing damage caused by UV exposure through the use of a nanoparticle delivery vehicle. The bioadhesive feature of this technology enables longer protection. In addition, encapsulation of the UV filter in a bioadhesive nanoparticle (BNP) improves filter photo-stability, delays filter photo-degradation, and prevents reactive oxygen species (ROS) escape, thereby reducing the risk of cell damage and epidermal toxicity from UV filters.

Furthermore, the bioadhesive feature of our technology eliminates penetration into deeper skin layers or into the blood, minimizing the potential side-effects of UV filters. It is believed that the translation of this technology will provide a longer-lasting, safer, more protective UV sunscreen.

A Sunscreen Based on Bioadhesive Nanoparticles

Assessing the Safety and Efficacy of Multifunctional Skin-adhesive Nanoparticles for UV Protection in Humans

Skin reaction will be assessed by exam. The exam will look for evidence of irritation, inflammation, follicular occlusion. In addition, patients will report any skin reaction at site of application over one week. Severity of the skin reactions will be assessed in the following manner: severe reactions will include evidence of edema or blister formation, follicular pustules and/or marked erythema and pruritus.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
A Sunscreen Based on Bioadhesive Nanoparticles	NCT02668536	Melanoma UV Ray Skin Dam...	Standard Sunscr... BNP	18 Years -	Yale University
A Sunscreen Based on Bioadhesive Nanoparticles	NCT02668536	Melanoma UV Ray Skin Dam...	Standard Sunscr... BNP	18 Years -	Yale University

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