Sunscreening Agents Clinical Trial
Official title:
Human Phototoxicity Test
NCT number | NCT02962856 |
Other study ID # | 18823 |
Secondary ID | |
Status | Completed |
Phase | N/A |
First received | |
Last updated | |
Start date | November 2, 2016 |
Est. completion date | November 5, 2016 |
Verified date | December 2018 |
Source | Bayer |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
To determine the phototoxic potential of a topically applied article in human subjects
Status | Completed |
Enrollment | 38 |
Est. completion date | November 5, 2016 |
Est. primary completion date | November 5, 2016 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years to 60 Years |
Eligibility |
Inclusion Criteria: - be male or female between the ages of 18 and 60 inclusive; - be lightly pigmented (Fitzpatrick Skin Type I, II, III); - have read and signed the written Informed Consent Form and have completed a HIPAA Authorization Form in conformance with 45CFR Parts 160 and 164; - be in general good health as determined by the subject's medical history and in the discretion of the investigator; Exclusion Criteria: - have a visible sunburn; - have a history of sun hypersensitivity/photosensitivity or photosensitive dermatosis; - must not have a known sensitivity or allergy against any of the active and non-active ingredients of the test product. - have a history of allergies or sensitivities to cosmetics, toiletries or any dermatological products |
Country | Name | City | State |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
---|---|
Bayer |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Intensity of skin reactions will be evaluated using the 5 point grading scale | Up to 48 hours |
Status | Clinical Trial | Phase | |
---|---|---|---|
Completed |
NCT02779270 -
Test the Outdoor Usage for Sunscreen Products in Female Adults
|
N/A | |
Completed |
NCT02936583 -
Sun Protection Factor Assay (SPF Assay 207/2016)
|
N/A | |
Completed |
NCT02936544 -
Sun Protection Factor Assay (SPF Assay 204/2016)
|
N/A | |
Completed |
NCT02936557 -
Sun Protection Factor Assay (SPF Assay 205/2016)
|
N/A | |
Completed |
NCT02936570 -
Sun Protection Factor Assay (SPF Assay 206/2016)
|
N/A | |
Completed |
NCT05085327 -
Clinical Study to Evaluate the Sun Protection Factor (SPF) of Sunscreen Products
|
N/A | |
Completed |
NCT02760563 -
18611 - Sun Protection Factor Assay
|
N/A | |
Completed |
NCT02930798 -
Sun Protection Factor Assay (SPF Assay 203/2016)
|
N/A | |
Completed |
NCT02760576 -
18612 - Sun Protection Factor Assay
|
N/A | |
Completed |
NCT02854137 -
Evaluation of the Irritation Potential of Sunscreen Products in Human Eyes
|
N/A | |
Completed |
NCT02930772 -
Sun Protection Factor Assay (SPF Assay 201/2016)
|
N/A | |
Completed |
NCT02930746 -
Sun Protection Factor Assay (SPF Assay 199/2016)
|
N/A | |
Completed |
NCT02930785 -
Sun Protection Factor Assay (SPF Assay 202/2016)
|
N/A | |
Completed |
NCT02930759 -
Sun Protection Factor Assay (SPF Assay 200/2016)
|
N/A | |
Completed |
NCT05109104 -
Clinical Study to Evaluate the Sun Protection Factor (SPF) of Three Sunscreen Products
|
N/A | |
Completed |
NCT04355286 -
Bemotrizinol UV Filter Part 1 Clinical PK Evaluation in Topical MUsT Study
|
Phase 1 | |
Completed |
NCT02962869 -
Human Photoallergy Test (824/2016)
|
N/A | |
Completed |
NCT02823496 -
18349-Human Photoallergy Test
|
N/A | |
Completed |
NCT02823483 -
18348-Human Phototoxicity Test
|
N/A | |
Completed |
NCT05124899 -
Clinical Study to Evaluate the 80-Minute Water Resistant Sun Protection Factor (SPF) of Sunscreen Products
|
N/A |