An interventional study of SPF 50 Y65 110 (BAY987519) and SPF 50 Y51 002 (BAY987519) in Photoallergy, 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 tudy was to evaluate the potential of photoallergy of of sun care products Sun Protection Factor (SPF) 50 Y65 110, SPF 50 Y51 002, and SPF 15 V27 104 application compared to that of a negative control (0.9% sodium chloride, NaCl) and followed by irradiation with UV A and UVB.
The secondary objective aims for evaluation of the safety of SPF 50 Y65 110, SPF 50 Y51 002, and SPF 15 V27 104 combined with ultraviolet (UV) A/B irradiation by monitoring adverse events (AEs) throughout the study.
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Inclusion Criteria:
All test products 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).
Evaluation of inflammatory responses
Inflammatory responses (Based on scores): 0 = No visible reaction + = Slight, confluent, or patchy erythema 1 = Mild erythema (pink) 2 = Moderate erythema (definite redness) 3 = Strong erythema (very intense redness)
Time frame: up to 3 weeks
Evaluation of superficial effects
Superficial effects: g = Glazing y = Peeling c = Scab, dried film of serous exudate of vesicular or bulla reaction d = Hyperpigmentation (reddish brown discoloration of test site) h = Hypopigmentation (loss of visible pigmentation at test site) f = Fissuring grooves in the superficial layers of the skin
Time frame: up to 3 weeks
Adverse event collection as a measure of safety and tolerability
Time frame: up to 3 weeks
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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Dermatitis, Photoallergic
Bayer