An interventional study of SPF 50 Y65 110 (BAY987519) and SPF 50 Y51 002 (BAY987519) in Sunscreen Agents, sponsored by Bayer. Completed at 1 site in United States. Open to participants aged 18 Years to 65 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2018-12-12.
Sponsored by Bayer · Not applicable, Interventional, and Other
The primary objective of this study was to evaluate the potential for phototoxicity of the sun care products SPF 50 Y65 110, SPF 50 Y51 002, and SPF 15 V27 104 compared to that of a negative control (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).
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.
22 studies on the registry are indexed under Dermatitis, Phototoxic; 1 is open to participants now.
This study's enrollment of 32 is close to the median of 35 across 19 interventional studies indexed under Dermatitis, Phototoxic.
Browse Dermatitis, Phototoxic studies →Bayer is the lead sponsor of 1,643 studies on the registry; 57 are open to participants now.
Of its 209 completed or terminated interventional studies of FDA-regulated products, 129 (62%) have results posted.
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Inclusion Criteria:
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.
Drug: SPF 50 Y65 110 (BAY987519) · Drug: SPF 50 Y51 002 (BAY987519) · Drug: SPF 15 V27 104 (BAY987519) · Drug: Sodium chloride [NaCl]
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.
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.
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.
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).
Skin irritation
Skin irritation was rated on a scale from 0-7 where 0 is no evidence of irritation and 7 is strong reaction spreading beyond test site
Time frame: up to 1 week
Number of adverse event as a measure of safety and tolerability
Time frame: up to 1 week
This study is completed, as verified in Dec 2018. You cannot join it, but the record below documents what was studied.
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