Assessing a Natural Product Plus Bioadhesive Nanoparticle (BNP) Sunscreen

• Status: Not yet recruiting
• Trial end date: 2023-12-01
• Target enrollment: 0
• Participant gender: All

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).

• Phase: Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Yale University
• Collaborator: National Cancer Institute (NCI)
• Treatments: Sunscreening Agents

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