Assessing a Natural Product Plus Bioadhesive Nanoparticle (BNP) Sunscreen

NCT ID: NCT05736224

Last Updated: 2024-11-27

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-05-15
• Study Completion Date: 2023-09-01

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.

Conditions

Skin Cancer

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: SINGLE

Study Groups

Sunscreen

Portion of skin covered by sunscreen. There are 3 different formulations of sunscreen (Formulation 1, Formulation 2, Formulation 3)

Group Type: EXPERIMENTAL

Sunscreen

Intervention Type: DRUG

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

UV Light

Intervention Type: OTHER

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

No treatment control

Portion of skin not covered by sunscreen.

Group Type: OTHER

UV Light

Intervention Type: OTHER

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

Interventions

Sunscreen

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: DRUG

UV Light

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

Intervention Type: OTHER

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

National Cancer Institute (NCI)

NIH

Sponsor Role: collaborator

Yale University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Michael Girardi, MD, FAAD

Role: PRINCIPAL_INVESTIGATOR

Evans Professor of Dermatology; Director, Residency Program, Dermatology

Locations

Yale School of Medicine

New Haven, Connecticut, United States

Countries

United States

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Document Type: Informed Consent Form

View Document

Other Identifiers

2P50CA121974-11A1

Identifier Type: NIH

Identifier Source: secondary_id

View Link

2000033876

Identifier Type: -

Identifier Source: org_study_id