Neoplasms

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Skin Neoplasms

Skin Diseases

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All Drugs and Chemicals

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Sunscreening Agents

Resveratrol

Avobenzone

Ferulic acid

Protective Agents

Radiation-Protective Agents

Ferulic Acid

Portion of skin not covered by sunscreen.

The sunscreen contains bioadhesive nanoparticles (BNP) encapsulating avobenzone and octocrylene plus the non-toxic natural products diosmin, ferulic acid, cytisine and trans-resveratrol.

Sunscreen

UV light to the correct sites, and the Multiport 610 solar simulator used to deliver 1 MED UVR to the appropriate subsites.

UV Light

Michael Girardi, MD, FAAD

The primary objective of this study is to evaluate the effects of a novel sunscreen formulation by assessing the extent of ultraviolet radiation (UVR)-induced direct and indirect cellular and DNA damage to human skin, in the presence vs absence of the sunscreen, in a population of healthy adults with fair skin (Fitzpatrick Scale type I, II or III).

Skin cancer is the most commonly diagnosed malignancy in the USA and ultraviolet radiation (UVR) exposure is the major environmental risk factor for skin cancer development. Currently available sunscreens utilize UVR filters that, while absorbing UVR energy, have been shown to induce ROS, resulting in oxidative DNA damage after UVR exposure. Organic sunscreen actives have also been shown to penetrate into the skin, raising direct toxicity, as well as irritant and photoallergic concerns. Further systemic absorption may result in additional health risks such as endocrine disruption. Novel sunscreens that more safely prevent both direct and indirect DNA damage are needed.

The study team have produced a bioadhesive nanoparticle (BNP) sunscreen designed to keep organic UVR filters from penetrating into the skin and have incorporated non-toxic natural products into this sunscreen to further safely boost UVR absorbing capacity and reduce oxidative, indirect DNA damage. This study will test the capacity of this sunscreen to prevent direct and indirect cellular and DNA damage in human skin exposed to UVR.

Within subject design where participant serves as own control.

Laboratory technicians will be blinded to treatment of samples.

Assessing a Natural Product Plus Bioadhesive Nanoparticle (BNP) Sunscreen

Individual participant data that underlie the results published from this study, after deidentification (text, tables, figures, and appendices), will be made available to researchers who provide a methodologically sound proposal. Proposals should be directed to michael.girardi@yale.edu.

Ultraviolet radiation (UVR) exposure are indicative of direct DNA damage. DNA will be prepared and assayed by ELISA for quantification of CPDs. CPDs measured in samples obtained immediately after UVR exposure are indicative of direct DNA damage.

Formalin fixed paraffin embedded skin will be stained with anti-gH2AX to identify DNA strand breaks. Indirect, oxidative DNA damage may result in DNA strand breaks that can be quantified by microscopic visualization of gH2AX, which builds up at the site of each strand break.

Formalin fixed paraffin embedded skin will be stained with anti-3-nitrotyrosine to identify cellular damage. ROS and high energy triplet state species can result in nitration of tyrosine residues of cellular proteins. This type of damage can be quantified by microscopic visualization of 3-nitrotyrosine.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
Assessing a Natural Product Plus Bioadhesive Nanoparticle (BNP) Sunscreen	NCT05736224	Skin Cancer	Sunscreen UV Light	18 Years -	Yale University
Assessing a Natural Product Plus Bioadhesive Nanoparticle (BNP) Sunscreen	NCT05736224	Skin Cancer	Sunscreen UV Light	18 Years -	Yale University

Spots Global Cancer Trial Database for uv light

Every month we try and update this database with for uv light cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Spots Global Cancer Trial Database for uv light

Every month we try and update this database with for uv light cancer trials from around the world to help patients and their families find trials that might be right for them. We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Every month we try and update this database with for uv light cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.