Clinical trial NCT05736224: Assessing a Natural Product Plus Bioadhesive Nanoparticle (BNP) Sunscreen
Official title: Assessing a Natural Product Plus Bioadhesive Nanoparticle (BNP) Sunscreen
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Skin Cancer
Lead sponsor: Yale University
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
First posted: 2023-02-21
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Within subject design where participant serves as own control.
Primary purpose: PREVENTION

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.

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

Primary outcomes:
measure: DNA Damage Level by Cyclobutane Pyrimidine Dimer (CPD) Measurement
timeFrame: 5 minutes after UVR exposure
measure: DNA Damage Level by Cyclobutane Pyrimidine Dimer (CPD) Measurement
timeFrame: 4 hours after UVR exposure
measure: Detectable DNA Strand Breaks
timeFrame: 5 minutes after UVR exposure
measure: Number of DNA Strand Breaks
timeFrame: 4 hours after UVR exposure
measure: Cellular Damage
timeFrame: 5 minutes after UVR exposure
measure: Cellular Damage
timeFrame: 4 hours after UVR exposure
Secondary outcomes:
Other outcomes:
Locations:
city: New Haven
country: United States
facility: Yale School of Medicine
state: Connecticut
Study officials:
affiliation: Evans Professor of Dermatology; Director, Residency Program, Dermatology
name: Michael Girardi, MD, FAAD
role: PRINCIPAL_INVESTIGATOR
References: