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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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| SPF 50 Y65 110, SPF 50 Y51 002, and SPF 15 V27 104 | Experimental | All test products compared to that of a negative control [0.9% NaCl] were tested simultaneously on each subject. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| SPF 50 Y65 110 (BAY987519) | Drug | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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) | 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 | up to 3 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Adverse event collection as a measure of safety and tolerability | up to 3 weeks |
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Inclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Bayer Study Director | Bayer | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Pinellas Park | Florida | 33781 | United States |
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| ID | Term |
|---|---|
| D017454 | Dermatitis, Photoallergic |
| ID | Term |
|---|---|
| D017449 | Dermatitis, Allergic Contact |
| D003877 | Dermatitis, Contact |
| D003872 | Dermatitis |
| D012871 | Skin Diseases |
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| ID | Term |
|---|---|
| D012965 | Sodium Chloride |
| ID | Term |
|---|---|
| D002712 | Chlorides |
| D006851 | Hydrochloric Acid |
| D017606 | Chlorine Compounds |
| D007287 | Inorganic Chemicals |
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| SPF 50 Y51 002 (BAY987519) | Drug | 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) | Drug | 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] | Drug | 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). |
|
| D017437 |
| Skin and Connective Tissue Diseases |
| D010787 | Photosensitivity Disorders |
| D017443 | Skin Diseases, Eczematous |
| D006968 | Hypersensitivity, Delayed |
| D006967 | Hypersensitivity |
| D007154 | Immune System Diseases |
| D017670 |
| Sodium Compounds |