Assessing a Natural Product Plus Bioadhesive Nanoparticle (BNP) Sunscreen

Skin Cancer Clinical Trial

Official title:

Assessing a Natural Product Plus Bioadhesive Nanoparticle (BNP) Sunscreen

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05736224
• Other study ID #: 2000033876
• Secondary ID: 2P50CA121974-11A
• Status: Completed
• Phase: Phase 1
• Start date: May 15, 2023
• Est. completion date: September 1, 2023

Study information

• Verified date: February 2024
• Source: Yale University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: September 1, 2023
• Est. primary completion date: September 1, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Skin Cancer
• Skin Neoplasms

Intervention

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

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

Locations

Country	Name	City	State
United States	Yale School of Medicine	New Haven	Connecticut

Sponsors (2)

Lead Sponsor	Collaborator
Yale University	National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	24 hours
Primary	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.	24 hours
Primary	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.	24 hours