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Assessing a Natural Product Plus Bioadhesive Nanoparticle (BNP) Sunscreen

Primary Purpose

Skin Cancer

Status
Recruiting
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
Sunscreen
UV Light
Sponsored by
Yale University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Skin Cancer

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria: Provision of signed and dated informed consent form Stated willingness to comply with all study procedures and availability for the duration of the study Women of child-bearing potential must have negative urine pregnancy test In good general health as evidenced by medical history Fair skinned with Fitzpatrick Scale skin types I, II or III using the following Skin Type and Sunburn and Tanning History (based on the first 30-45 minutes of sun exposure after a winter season of no sun exposure): I always burns easily; never tans (sensitive) II always burns easily; tans minimally (sensitive) III burns moderately; tans gradually (light brown) (normal) Exclusion Criteria: Individuals with active or a history of dermatological disorders-psoriasis, rosacea, eczema, vitiligo, lupus, dermatomyositis, etc Individuals known to be subject to any abnormal responses to sunlight, such as phototoxic or photoallergic response. Current use of medication (topical or systemic) that is known to produce abnormal sunlight responses. History of skin cancer (such as basal cell carcinoma, squamous cell carcinoma, melanoma) Family history of melanoma Presence of sunburn, suntan, scars, active dermal lesions or uneven skin tone on the test site. Skin type falling under the Fitzpatrick Scale skin types IV, V or VI using the following Skin Type and Sunburn and Tanning History (based on the first 30-45 minutes of sun exposure after a winter season of no sun exposure): IV Burns minimally; always tans well (moderate brown) (normal) V Rarely burns; tans profusely (dark brown) (insensitive) Use of sunscreen within the last week on the test site area (such that UV filter penetration may confound results) Febrile illness within 48 hours. Women with a positive urine pregnancy test

Sites / Locations

  • Yale School of MedicineRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Other

Arm Label

Sunscreen

No treatment control

Arm Description

Portion of skin covered by sunscreen.

Portion of skin not covered by sunscreen.

Outcomes

Primary Outcome Measures

UVR Exposure
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.
DNA Strand Breaks
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.
Cellular Damage
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.

Secondary Outcome Measures

Full Information

First Posted
February 9, 2023
Last Updated
August 23, 2023
Sponsor
Yale University
Collaborators
National Cancer Institute (NCI)
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1. Study Identification

Unique Protocol Identification Number
NCT05736224
Brief Title
Assessing a Natural Product Plus Bioadhesive Nanoparticle (BNP) Sunscreen
Official Title
Assessing a Natural Product Plus Bioadhesive Nanoparticle (BNP) Sunscreen
Study Type
Interventional

2. Study Status

Record Verification Date
August 2023
Overall Recruitment Status
Recruiting
Study Start Date
May 15, 2023 (Actual)
Primary Completion Date
September 2023 (Anticipated)
Study Completion Date
December 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Yale University
Collaborators
National Cancer Institute (NCI)

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
Yes
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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).
Detailed Description
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Skin Cancer

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Model Description
Within subject design where participant serves as own control.
Masking
Outcomes Assessor
Masking Description
Laboratory technicians will be blinded to treatment of samples.
Allocation
Non-Randomized
Enrollment
30 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Sunscreen
Arm Type
Experimental
Arm Description
Portion of skin covered by sunscreen.
Arm Title
No treatment control
Arm Type
Other
Arm Description
Portion of skin not covered by sunscreen.
Intervention Type
Drug
Intervention Name(s)
Sunscreen
Intervention Description
The sunscreen contains bioadhesive nanoparticles (BNP) encapsulating avobenzone and octocrylene plus the non-toxic natural products diosmin, ferulic acid, cytisine and trans-resveratrol.
Intervention Type
Other
Intervention Name(s)
UV Light
Intervention Description
UV light to the correct sites, and the Multiport 610 solar simulator used to deliver 1 MED UVR to the appropriate subsites.
Primary Outcome Measure Information:
Title
UVR Exposure
Description
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.
Time Frame
24 hours
Title
DNA Strand Breaks
Description
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.
Time Frame
24 hours
Title
Cellular Damage
Description
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.
Time Frame
24 hours

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Provision of signed and dated informed consent form Stated willingness to comply with all study procedures and availability for the duration of the study Women of child-bearing potential must have negative urine pregnancy test In good general health as evidenced by medical history Fair skinned with Fitzpatrick Scale skin types I, II or III using the following Skin Type and Sunburn and Tanning History (based on the first 30-45 minutes of sun exposure after a winter season of no sun exposure): I always burns easily; never tans (sensitive) II always burns easily; tans minimally (sensitive) III burns moderately; tans gradually (light brown) (normal) Exclusion Criteria: Individuals with active or a history of dermatological disorders-psoriasis, rosacea, eczema, vitiligo, lupus, dermatomyositis, etc Individuals known to be subject to any abnormal responses to sunlight, such as phototoxic or photoallergic response. Current use of medication (topical or systemic) that is known to produce abnormal sunlight responses. History of skin cancer (such as basal cell carcinoma, squamous cell carcinoma, melanoma) Family history of melanoma Presence of sunburn, suntan, scars, active dermal lesions or uneven skin tone on the test site. Skin type falling under the Fitzpatrick Scale skin types IV, V or VI using the following Skin Type and Sunburn and Tanning History (based on the first 30-45 minutes of sun exposure after a winter season of no sun exposure): IV Burns minimally; always tans well (moderate brown) (normal) V Rarely burns; tans profusely (dark brown) (insensitive) Use of sunscreen within the last week on the test site area (such that UV filter penetration may confound results) Febrile illness within 48 hours. Women with a positive urine pregnancy test
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Kacie Carlson, PA-C, MPAS
Phone
203) 785-7432
Email
kacie.carlson@yale.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Michael Girardi, MD, FAAD
Phone
(203) 785-4092
Email
michael.girardi@yale.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Michael Girardi, MD, FAAD
Organizational Affiliation
Evans Professor of Dermatology; Director, Residency Program, Dermatology
Official's Role
Principal Investigator
Facility Information:
Facility Name
Yale School of Medicine
City
New Haven
State/Province
Connecticut
ZIP/Postal Code
06511
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Michael Girardi, MD, FAAD
Phone
203-785-4092
Email
michael.girardi@yale.edu

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
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.
IPD Sharing Time Frame
Beginning 3 months and ending 5 years following article publication.
IPD Sharing Access Criteria
Access will be given to researchers who provide a methodologically sound proposal. Proposals should be directed to michael.girardi@yale.edu. To gain access, data requestors will need to sign a data access agreement.

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Assessing a Natural Product Plus Bioadhesive Nanoparticle (BNP) Sunscreen

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