Back to resultsHuman Phototoxicity Test
Primary Purpose
Sunscreening Agents
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Sunscreen Sport Lotion (BAY987516)
Untreated Skin
Sponsored by
About this trial
This is an interventional other trial for Sunscreening Agents
Eligibility Criteria
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 Health Insurance Portability and Accountability Act (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 dermatoses;
- 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;
Sites / Locations
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Arm 1
Arm Description
All subjects are patched.
Outcomes
Primary Outcome Measures
Intensity of skin reactions will be evaluated using the 5 point grading scale
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02750475
Brief Title
Human Phototoxicity Test
Official Title
Human Phototoxicity Test
Study Type
Interventional
2. Study Status
Record Verification Date
December 2018
Overall Recruitment Status
Completed
Study Start Date
May 2, 2016 (Actual)
Primary Completion Date
May 6, 2016 (Actual)
Study Completion Date
May 6, 2016 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Bayer
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
To determine the phototoxic potential of a topically applied article in human subjects
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Sunscreening Agents
7. Study Design
Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
35 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Arm 1
Arm Type
Experimental
Arm Description
All subjects are patched.
Intervention Type
Drug
Intervention Name(s)
Sunscreen Sport Lotion (BAY987516)
Intervention Description
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.(Formulation number - RB# Y65-110)
Intervention Type
Other
Intervention Name(s)
Untreated Skin
Intervention Description
This site is patched without treatment as irradiated control
Primary Outcome Measure Information:
Title
Intensity of skin reactions will be evaluated using the 5 point grading scale
Time Frame
Up to 48 hours
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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 Health Insurance Portability and Accountability Act (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 dermatoses;
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;
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Bayer Study Director
Organizational Affiliation
Bayer
Official's Role
Study Director
Facility Information:
City
Piscataway
State/Province
New Jersey
ZIP/Postal Code
08854
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Human Phototoxicity Test
We'll reach out to this number within 24 hrs