Clinical trial NCT02952235: Evaluation of Sunscreens Under Actual Use Conditions
Official title: A Single Center, Randomized, Split-Face, Double-Blinded, Single Sun Exposure Evaluation of Sunscreens of SPF 50+ and Above Under Actual Use Conditions
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Sun Protection
Lead sponsor: Johnson & Johnson Consumer and Personal Products Worldwide
Sponsor class: INDUSTRY
First posted: 2016-11-02
Enrollment: 199
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: Use of two high SPF sunscreens under actual use conditions.

Detailed 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.

Eligibility criteria: Inclusion Criteria:

1. Males and Females with Fitzpatrick Skin Types I-III
2. At least 18 years old
3. Able to read, write, speak and understand the English language.
4. Has personally read, signed, and dated the Informed Consent Form (including HIPAA disclosure) and Photograph Release
5. Generally in good health based on medical history reported by the subject
6. Healthy male or female subjects with no history or evidence of clinically relevant medical disorder, as determined from a brief medical history interview.
7. 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:

1. Individuals with known allergies or sensitivities to sunscreens or any ingredient contained in the test products or common topical skincare products, including adhesives.
2. Observable Sunburn (erythema score above 0.5) on the face and neck as determined by the PI or designee.
3. Women known to be pregnant or nursing.
4. 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.
5. Individuals with self-reported UNCONTROLLED metabolic conditions, such as diabetes, hypertension, hyper/hypothyroidism, hypercholesterolemia
6. Subjects who are taking medication for chronic conditions that may make a subject more sun sensitive (e.g., Tetracyclines, antifungals, certain diuretics, etc.)
7. Skin diseases on tested sites (e.g., photosensitivity disorders, etc.), which may influence the outcome of the study
8. Wearing of a full head covered ski mask.
9. An individual who has any condition which in the PI's judgment makes the candidate an inappropriate subject for study participation
10. 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)
11. 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
12. Individual viewed by the PI as not being able to complete the study

Primary outcomes:
measure: Side-by-side Comparison (overall difference) of Sunburn.
timeFrame: Day 2
Secondary outcomes:
measure: Difference in Erythema Score Between Left and Right Sides at Day 2
timeFrame: Day 2
Other outcomes:
Locations:
Study officials:
affiliation: Sponsor GmbH
name: Joshua Williams, PhD
role: STUDY_DIRECTOR
References: