Back to resultsTest the Phototoxicity of Sunscreen Products
Primary Purpose
Sunscreen Agents
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
SPF 50 Y65 110 (BAY987519)
SPF 50 Y51 002 (BAY987519)
SPF 15 V27 104 (BAY987519)
Sodium chloride [NaCl]
Sponsored by
About this trial
This is an interventional other trial for Sunscreen Agents
Eligibility Criteria
Inclusion Criteria:
- Male or female subjects, aged 18 to 65 years
- Good general health, as assessed by medical history and brief visual examination of the skin
- Fitzpatrick skin Type I IV, determined by interview at screening
- Willing and able to practice an acceptable measure of contraception during the study, if female of childbearing potential
- Willing to follow study rules, which include: no sun exposure; avoidance of activities that would cause excessive sweating; and no use of lotions, creams, or oils on the back area
- Must be willing not to change current brand of personal care products such as soaps, body washes, laundry detergent, body sprays, and body spritzes while participating in the study
Sites / Locations
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
SPF 50 Y65 110, SPF 50 Y51 002, and SPF 15 V27 104
Arm Description
All test products (SPF 50 Y65 110,SPF 50 Y51 002, and SPF 15 V27 l 04 compared to that of a negative control [0.9% NaCl]) were tested simultaneously on each subject.
Outcomes
Primary Outcome Measures
Skin irritation
Skin irritation was rated on a scale from 0-7 where 0 is no evidence of irritation and 7 is strong reaction spreading beyond test site
Secondary Outcome Measures
Number of adverse event as a measure of safety and tolerability
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02802930
Brief Title
Test the Phototoxicity of Sunscreen Products
Official Title
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
Study Type
Interventional
2. Study Status
Record Verification Date
December 2018
Overall Recruitment Status
Completed
Study Start Date
April 20, 2015 (Actual)
Primary Completion Date
April 26, 2015 (Actual)
Study Completion Date
April 26, 2015 (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
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Sunscreen Agents
7. Study Design
Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
Participant
Allocation
N/A
Enrollment
32 (Actual)
8. Arms, Groups, and Interventions
Arm Title
SPF 50 Y65 110, SPF 50 Y51 002, and SPF 15 V27 104
Arm Type
Experimental
Arm Description
All test products (SPF 50 Y65 110,SPF 50 Y51 002, and SPF 15 V27 l 04 compared to that of a negative control [0.9% NaCl]) were tested simultaneously on each subject.
Intervention Type
Drug
Intervention Name(s)
SPF 50 Y65 110 (BAY987519)
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
SPF 50 Y51 002 (BAY987519)
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
SPF 15 V27 104 (BAY987519)
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
Sodium chloride [NaCl]
Intervention Description
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).
Primary Outcome Measure Information:
Title
Skin irritation
Description
Skin irritation was rated on a scale from 0-7 where 0 is no evidence of irritation and 7 is strong reaction spreading beyond test site
Time Frame
up to 1 week
Secondary Outcome Measure Information:
Title
Number of adverse event as a measure of safety and tolerability
Time Frame
up to 1 week
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Male or female subjects, aged 18 to 65 years
Good general health, as assessed by medical history and brief visual examination of the skin
Fitzpatrick skin Type I IV, determined by interview at screening
Willing and able to practice an acceptable measure of contraception during the study, if female of childbearing potential
Willing to follow study rules, which include: no sun exposure; avoidance of activities that would cause excessive sweating; and no use of lotions, creams, or oils on the back area
Must be willing not to change current brand of personal care products such as soaps, body washes, laundry detergent, body sprays, and body spritzes while participating in the study
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Bayer Study Director
Organizational Affiliation
Bayer
Official's Role
Study Director
Facility Information:
City
Pinellas Park
State/Province
Florida
ZIP/Postal Code
33781
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Test the Phototoxicity of Sunscreen Products
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