Trials / Completed
CompletedNCT02802930
Test the Phototoxicity of Sunscreen Products
A Randomized Study to Assess the Potential for Phototoxicity of SPF 50 Y65 110, SPF 50 Y51 002 and SPF 15 V27-104 in Human Subjects
- Status
- Completed
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 32 (actual)
- Sponsor
- Bayer · Industry
- Sex
- All
- Age
- 18 Years – 65 Years
- Healthy volunteers
- Accepted
Summary
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | 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. |
| DRUG | 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. |
| DRUG | 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. |
| DRUG | 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). |
Timeline
- Start date
- 2015-04-20
- Primary completion
- 2015-04-26
- Completion
- 2015-04-26
- First posted
- 2016-06-16
- Last updated
- 2018-12-12
Locations
1 site across 1 country: United States
Source: ClinicalTrials.gov record NCT02802930. Inclusion in this directory is not an endorsement.