Multiday Beach Study

NCT03041064 | Completed

• 1 other identifier: CO-1602 0409 2933-SACT
• Study Type: interventional
• Target: 55
• Locations: 0 countries
• Sites: N/A

Brief Summary

This is a randomized, double-blinded, single-center, split body and split face, multiple natural sunlight exposure evaluation of two marketed sunscreens under actual use conditions in healthy volunteers. Eligible subjects will be randomized to two treatment randomization groups: Left SPF (Sun Protection Factor) 100+/Right SPF 50+ or Left SPF 50+/Right SPF 100+. Assessment of erythema and pigmentation will be performed at baseline and after all natural sunlight exposure periods which will occur on at the same beach location over the course of 5 consecutive days. Subjects will be suspended from further natural light exposure periods following the observation of sunburn at any exposed body site.

Conditions

Erythema

Outcome Measures

Primary Outcomes (2)

• Mean bilateral sunburn comparison over matched exposure sites and sun exposure periods

  The clinical evaluator assessed exposure sites for UV (SPF 50+ and SPF 100+ sunscreen) induced erythema 12-24 hours after a period of sun exposure . Clinical evaluation assessed erythema via a side-by-side comparison of the three exposure areas (matched sites) utilizing the bilateral comparison score (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

  Days 1-7

• Mean erythema scores over exposure areas and exposure periods, calculated separately for the left and right sides of the body/face

  Clinical evaluator independently assessed each side of each exposure area for erythema utilizing the erythema assessment score. Erythema score for each of the 6 exposure areas utilizing a scale of 0-4 with permission for intermediate (half-point) grades ( 0 = no burn; 1 = possible burn, not clearly defined; 2 = defined redness clearly caused by UV; 3 = severe sunburn with pronounced redness; 4 = edema and blisters).

  Days 1-7

Secondary Outcomes (24)

• Clinical evaluation of bilateral sunburn (erythema) comparison by exposure site and exposure period.

  Days 3-7

• Mean clinically evaluated bilateral sunburn (erythema) comparison per subject by exposure period.

  Days 3-7

• Mean clinically evaluated bilateral sunburn (erythema) comparison over exposure period by matched exposure site.

  Days 3-7

• Clinically evaluated erythema score by exposure site and exposure period.

  Days 3-7

• Change from baseline in clinically evaluated erythema score by exposure site and exposure period.

  Days 3-7

Study Arms (2)

SPF 50/SPF 100

EXPERIMENTAL

SPF 50 assigned to left side of face and body. SPF 100 assigned to right side of face and body

Other: 50/100

SPF 100/SPF 50

EXPERIMENTAL

SPF 100 assigned to left side of face and body. SPF 50 assigned to right side of face and body

Other: 100/50

Interventions

50/100 OTHER

SPF

SPF 50/SPF 100

100/50 OTHER

SPF

SPF 100/SPF 50

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Male or female
• 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.

You may not qualify if:

• 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.)

Sponsors & Collaborators

• Johnson & Johnson Consumer and Personal Products Worldwide: lead

Related Publications (1)

• Kohli I, Nicholson CL, Williams JD, Lyons AB, Seo I, Maitra P, Tian X, Atillasoy E, Lim HW, Hamzavi IH. Greater efficacy of SPF 100+ sunscreen compared with SPF 50+ in sunburn prevention during 5 consecutive days of sunlight exposure: A randomized, double-blind clinical trial. J Am Acad Dermatol. 2020 Apr;82(4):869-877. doi: 10.1016/j.jaad.2019.09.018. Epub 2019 Sep 19.

  PMID: 31542406 RESULT

MeSH Terms

Conditions

Erythema

Condition Hierarchy (Ancestors)

Skin Diseases; Skin and Connective Tissue Diseases; Skin Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 13, 2016
• First Posted: February 2, 2017
• Study Start: May 27, 2016
• Primary Completion: June 1, 2016
• Study Completion: June 1, 2016
• Last Updated: December 18, 2019

Record last verified: 2019-12