Back to resultsTo Test for Photo Allergy Reaction of Sunscreens
Primary Purpose
Photoallergy
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 Photoallergy
Eligibility Criteria
Inclusion Criteria:
- Men or women, aged 18 to 65 with good general health
- Fitzpatrick skin type I IV
- Females (of childbearing potential) on acceptable measure of contraception
- Willing to follow study rules, which include: no sun exposure (for example, no swimming, sunbathing, or tanning beds), avoidance of activities that would cause excessive sweating, no use of lotions, creams, or oils on the back area
- Willing to not change the current brand of personal care products such as soaps, body washes, laundry detergent, body sprays, body spritzes, etc. 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 compared to that of a negative control [0.9% NaCl] were tested simultaneously on each subject.
Outcomes
Primary Outcome Measures
Evaluation of inflammatory responses
Inflammatory responses (Based on scores): 0 = No visible reaction + = Slight, confluent, or patchy erythema 1 = Mild erythema (pink) 2 = Moderate erythema (definite redness) 3 = Strong erythema (very intense redness)
Evaluation of superficial effects
Superficial effects: g = Glazing y = Peeling c = Scab, dried film of serous exudate of vesicular or bulla reaction d = Hyperpigmentation (reddish brown discoloration of test site) h = Hypopigmentation (loss of visible pigmentation at test site) f = Fissuring grooves in the superficial layers of the skin
Secondary Outcome Measures
Adverse event collection as a measure of safety and tolerability
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02872220
Brief Title
To Test for Photo Allergy Reaction of Sunscreens
Official Title
A Randomized Study to Assess the Potential for Photoallergy 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
March 23, 2015 (Actual)
Primary Completion Date
May 8, 2015 (Actual)
Study Completion Date
May 8, 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 tudy was to evaluate the potential of photoallergy of of sun care products Sun Protection Factor (SPF) 50 Y65 110, SPF 50 Y51 002, and SPF 15 V27 104 application compared to that of a negative control (0.9% sodium chloride, NaCl) and followed by irradiation with UV A and UVB.
The secondary objective aims for evaluation of the safety of SPF 50 Y65 110, SPF 50 Y51 002, and SPF 15 V27 104 combined with ultraviolet (UV) A/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
Photoallergy
7. Study Design
Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
Participant
Allocation
N/A
Enrollment
56 (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 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
Evaluation of inflammatory responses
Description
Inflammatory responses (Based on scores): 0 = No visible reaction + = Slight, confluent, or patchy erythema 1 = Mild erythema (pink) 2 = Moderate erythema (definite redness) 3 = Strong erythema (very intense redness)
Time Frame
up to 3 weeks
Title
Evaluation of superficial effects
Description
Superficial effects: g = Glazing y = Peeling c = Scab, dried film of serous exudate of vesicular or bulla reaction d = Hyperpigmentation (reddish brown discoloration of test site) h = Hypopigmentation (loss of visible pigmentation at test site) f = Fissuring grooves in the superficial layers of the skin
Time Frame
up to 3 weeks
Secondary Outcome Measure Information:
Title
Adverse event collection as a measure of safety and tolerability
Time Frame
up to 3 weeks
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:
Men or women, aged 18 to 65 with good general health
Fitzpatrick skin type I IV
Females (of childbearing potential) on acceptable measure of contraception
Willing to follow study rules, which include: no sun exposure (for example, no swimming, sunbathing, or tanning beds), avoidance of activities that would cause excessive sweating, no use of lotions, creams, or oils on the back area
Willing to not change the current brand of personal care products such as soaps, body washes, laundry detergent, body sprays, body spritzes, etc. 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
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To Test for Photo Allergy Reaction of Sunscreens
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