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CompletedNCT02952235Updated Jun 8, 2017

Evaluation of Sunscreens Under Actual Use Conditions

An interventional study of SPF50+ and SPF100+ in Sun Protection, sponsored by Johnson & Johnson Consumer and Personal Products Worldwide. Completed. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2017-06-08.

Sponsored by Johnson & Johnson Consumer and Personal Products Worldwide · Not applicable, Interventional, and Other

From the registry’s dates

  • Registered 7 months after the study started (first participant enrolled Mar 2016, registered Oct 2016).
Phase
Not applicable
Study type
Interventional
Enrollment
199
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study summary

Use of two high SPF sunscreens under actual use conditions.

Read the 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.

02

Conditions studied

  • Sun Protection
03

In context

Lead sponsor

Johnson & Johnson Consumer and Personal Products Worldwide is the lead sponsor of 58 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
Yes

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

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
05

Study design

Phase
Not applicable
Primary purpose
Other
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Triple (Participant, Investigator, Outcomes assessor)
Enrollment
199 participants (actual)

Study arms

  • Other
    SPF50+

    SPF 50+ assigned to Left side of face SPF 100+ assigned to Right side of face

    Other: SPF50+

  • Other
    SPF100+

    SPF 100+ assigned to Left side of face SPF 50+ assigned to Right side of face

    Other: SPF100+

Interventions

  • OtherSPF50+

    Sun protection

    Also known as: Sunscreens

  • OtherSPF100+

    Sun protection

    Also known as: Sunscreens

06

What researchers measure

Primary outcomes

  1. Side-by-side Comparison (overall difference) of Sunburn.

    The side-by-side comparison utilized the following condensed two side overall difference scale: L1 = subject's left side noticeably more sunburned than right side, 0= no difference in sunburn, R1= subject's right side noticeably more sunburned than left side. The 0 outcomes were excluded from the analysis.

    Time frame: Day 2

Secondary outcomes

  1. Difference in Erythema Score Between Left and Right Sides at Day 2

    Erythema was assessed using a scale of 0 = no burn, 1 = possible burn, not clearly defined; 2 = defined redness clearly caused by UV; 3 = severe sunburn with pronounced redness; and 4 = edema and blisters

    Time frame: Day 2

07

Study locations

No study locations are listed for this record.

08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jun 8, 2017, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT02952235
Lead sponsor
Johnson & Johnson Consumer and Personal Products Worldwide
Responsible party
Sponsor
First posted
Nov 2, 2016
Start date
Mar 31, 2016
Primary completion
Mar 31, 2016
Completion
Mar 31, 2016
Last update
Jun 8, 2017

Study contacts

Joshua Williams, PhD
study director · Sponsor GmbH

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Jun 2017. You cannot join it, but the record below documents what was studied.

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