Multiday Beach Study

This is an interventional prevention trial for Erythema Read More

Inclusion Criteria:

• Male or female
• 18-60 years old
• Phototypes I, II and III according to Fitzpatrick's classification
• Be willing to not apply any topical products (face/body) and cleanse (face/body) each morning prior to study visit.
• Be willing to use study test products in place of current sun protection topical skincare products (this includes make-up) during study hours.
• Be willing to have 1x1 cm sites marked on your skin. A total of 12 sites will be marked including four on the face. Face sites will be marked by the corners only.
• Be willing to refrain from using other sunscreen products, excessive sun exposure or tanning beds outside of the study visits.
• Be willing to refrain from using new face/body cleanser products and brands cannot be switched during the study.
• Be willing to refrain from using any new personal care products (e.g. makeup) or changing existing brands during the study.
• Be willing to not shave or use any hair removal method on your face/body within the 24 hours prior to first study visit and for the study duration.

Exclusion Criteria:

• Individuals with known allergies or sensitivities to sunscreens or common topical skincare products.
• Presence of sunburn (i.e. clinical erythema score greater than 0), suntan, scars, tattoos, active dermal lesions, dysplastic nevi, uneven skin tone, damaged/broken skin, or excessive body hair* on the areas of skin to be evaluated. The presence of nevi (other than dysplastic nevi), blemishes, or moles is acceptable if, in the investigator's judgment, they will not compromise the study and will not jeopardize the subject's safety. Beach umbrellas are not permitted. Sunglasses are acceptable.
• *Hair is permitted to cover the back of the neck but long hair should be pulled into a ponytail leaving ears uncovered for Visits 2-6.
• Presence of excessive pigmentation (pre-existing sun tan) or photodamage on the exposure sites to be evaluated.
• Notable bilateral pigmentation discrepancies between the matched left and right side exposure sites (e.g., left arm more pigmented that right arm).
• For study day mornings, Subject has applied, and refuses to remove prior to acclimation, any topical products (face/body) to the areas of skin to be evaluated.
• Individuals with CONTROLLED health conditions. These individuals may be included in the study at the discretion of the PI:
• Subjects with conditions that do not affect the skin, such as hypertension and hypercholesterolemia, could be enrolled when their health condition is managed through diet, medication, etc.
• Subjects with conditions, which might affect the skin, such as hyper/hypothyroidism, diabetes must be excluded, regardless whether their health condition is controlled or not.
• Subjects who are taking medication for chronic conditions (e.g., insulin, antihistamines, steroidal and non-steroidal anti-inflammatory drugs, antibiotics, etc...) - exception could be made for hypercholesterolemia as per point VI.
• Individuals with any disease or condition of the skin including photosensitivity disorders (e.g., active [i.e. flaring] eczema or psoriasis, skin cancer, polymorphic light eruption (PMLE), systemic lupus erythematous (SLE), xeroderma pigmentosa) that could interfere with the study or increase risk to the subject.
• Subjects who are taking medication for chronic conditions that may make a subject more sun sensitive (e.g., Tetracyclines, antifungals, certain diuretics, etc.)