Trials / Completed
CompletedNCT02751372
18794 - Human Photo Toxicity Test
Human Phototoxicity Test
- Status
- Completed
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 35 (actual)
- Sponsor
- Bayer · Industry
- Sex
- All
- Age
- 18 Years – 60 Years
- Healthy volunteers
- Accepted
Summary
To determine the phototoxic potential of a topically applied article in human subjects.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | BAY 987517 | 50 μl/cm\*2 or 0.05 gm/cm\*2 of each test product is applied to duplicate skin sites (approximately 2 x 2 cm each). After the test articles have dried for 5 to 15 min, the sites are covered by the appropriate patch.24 hours later, the set of patches covering the product are removed. Three (3) μl/ cm2 or 0.003 gm/cm\*2 of the test product is reapplied to the test site, air dried for 5 to 15 minutes for volatilization and then the test site is exposed to UVA radiation. |
| OTHER | Untreated Skin | This site is patched without treatment as irradiated control |
Timeline
- Start date
- 2016-05-02
- Primary completion
- 2016-05-06
- Completion
- 2016-05-06
- First posted
- 2016-04-26
- Last updated
- 2018-12-13
Locations
1 site across 1 country: United States
Source: ClinicalTrials.gov record NCT02751372. Inclusion in this directory is not an endorsement.