Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
32 participants
INTERVENTIONAL
2015-04-20
2015-04-26
Brief Summary
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The secondary objective of this study was to evaluate the safety of the sun care products SPF 50 Y65 110, SPF 50 Y51 002, and SPF 15 V27 104 combined with UVA/B irradiation by monitoring adverse events (AEs) throughout the study.
Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
OTHER
SINGLE
Study Groups
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SPF 50 Y65 110, SPF 50 Y51 002, and SPF 15 V27 104
All test products (SPF 50 Y65 110,SPF 50 Y51 002, and SPF 15 V27 l 04 compared to that of a negative control \[0.9% NaCl\]) were tested simultaneously on each subject.
SPF 50 Y65 110 (BAY987519)
Application of 200 µL in an occlusive patch of Webril (0.150 ± 0.010 mg) compared to that of a negative control (0.9% sodium chloride, NaCl) and followed by irradiation with UV A and UVB.
SPF 50 Y51 002 (BAY987519)
Application of 200 µL in an occlusive patch of Webril compared to that of a negative control (0.9% sodium chloride, NaCl) and followed by irradiation with UV A and UVB.
SPF 15 V27 104 (BAY987519)
Application of 200 µL in an occlusive patch of Webril compared to that of a negative control (0.9% sodium chloride, NaCl) and followed by irradiation with UV A and UVB.
Sodium chloride [NaCl]
Negative control (200 µL, 0.9% sodium chloride \[NaCl\]) after a single 24 h application of test materials followed by irradiation with ultraviolet A (UVA) and ultraviolet B (UVB).
Interventions
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SPF 50 Y65 110 (BAY987519)
Application of 200 µL in an occlusive patch of Webril (0.150 ± 0.010 mg) compared to that of a negative control (0.9% sodium chloride, NaCl) and followed by irradiation with UV A and UVB.
SPF 50 Y51 002 (BAY987519)
Application of 200 µL in an occlusive patch of Webril compared to that of a negative control (0.9% sodium chloride, NaCl) and followed by irradiation with UV A and UVB.
SPF 15 V27 104 (BAY987519)
Application of 200 µL in an occlusive patch of Webril compared to that of a negative control (0.9% sodium chloride, NaCl) and followed by irradiation with UV A and UVB.
Sodium chloride [NaCl]
Negative control (200 µL, 0.9% sodium chloride \[NaCl\]) after a single 24 h application of test materials followed by irradiation with ultraviolet A (UVA) and ultraviolet B (UVB).
Eligibility Criteria
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Inclusion Criteria
* Good general health, as assessed by medical history and brief visual examination of the skin
* Fitzpatrick skin Type I IV, determined by interview at screening
* Willing and able to practice an acceptable measure of contraception during the study, if female of childbearing potential
* Willing to follow study rules, which include: no sun exposure; avoidance of activities that would cause excessive sweating; and no use of lotions, creams, or oils on the back area
* Must be willing not to change current brand of personal care products such as soaps, body washes, laundry detergent, body sprays, and body spritzes while participating in the study
18 Years
65 Years
ALL
Yes
Sponsors
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Bayer
INDUSTRY
Responsible Party
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Principal Investigators
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Bayer Study Director
Role: STUDY_DIRECTOR
Bayer
Locations
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Pinellas Park, Florida, United States
Countries
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Other Identifiers
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18287
Identifier Type: -
Identifier Source: org_study_id