Evaluation of Sunscreens Under Actual Use Conditions

Johnson & Johnson (J&J)

Status

Completed

Conditions

Sun Protection

Treatments

Other: SPF50+

Other: SPF100+

Study type

Interventional

Funder types

Industry

Identifiers

NCT02952235

CO-151112132858-SACT

Details and patient eligibility

About

Use of two high SPF sunscreens under actual use conditions.

Full description

To evaluate the difference in the level of sunburn (erythema) protection following a single period of natural sunlight exposure afforded by application of SPF 50+ and SPF 100+ sunscreens.

Enrollment

199 patients

Sex

All

Ages

18+ years old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

Males and Females with Fitzpatrick Skin Types I-III
At least 18 years old
Able to read, write, speak and understand the English language.
Has personally read, signed, and dated the Informed Consent Form (including HIPAA disclosure) and Photograph Release
Generally in good health based on medical history reported by the subject
Healthy male or female subjects with no history or evidence of clinically relevant medical disorder, as determined from a brief medical history interview.
Willing and able to follow the study instructions, including:

Remain outdoors for at least 5 hours on Day 1 during the study with face and neck uncovered (as much as possible)

Apply the test products (sunscreen) to designated sides of the face and neck
Remove any make-up, sunscreen, or other facial products at baseline prior to applying test product. Use test product in place of current sun protection topical skincare products (this includes make-up)
Attend scheduled visits and intend to successfully complete the study
Return ALL study products at Day 2 exit visit
Refrain from using other sunscreen products or tanning bed use during the duration of the study.

Exclusion criteria

Individuals with known allergies or sensitivities to sunscreens or any ingredient contained in the test products or common topical skincare products, including adhesives.
Observable Sunburn (erythema score above 0.5) on the face and neck as determined by the PI or designee.
Women known to be pregnant or nursing.
Individuals with any disease or condition of the skin (e.g., active [i.e. flaring] eczema or psoriasis, skin cancer, polymorphic light eruption (PMLE), systemic lupus erythematous (SLE), xerodermapigmentosa) that could interfere with the study or increase risk to the subject.
Individuals with self-reported UNCONTROLLED metabolic conditions, such as diabetes, hypertension, hyper/hypothyroidism, hypercholesterolemia
Subjects who are taking medication for chronic conditions that may make a subject more sun sensitive (e.g., Tetracyclines, antifungals, certain diuretics, etc.)
Skin diseases on tested sites (e.g., photosensitivity disorders, etc.), which may influence the outcome of the study
Wearing of a full head covered ski mask.
An individual who has any condition which in the PI's judgment makes the candidate an inappropriate subject for study participation
Subjects who are related to those persons involved directly or indirectly with the conduct of this study (i.e., PI, sub-investigators, study coordinators, other site personnel, employees of Johnson & Johnson subsidiaries, contractors of Johnson & Johnson, and the families of each)
Individuals with a condition or situation which, in the PI's opinion, may put the subject at significant risk, may confound the study results, or may interfere significantly with the subject's participation in the study
Individual viewed by the PI as not being able to complete the study