Sunscreen Agents Clinical Trial
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
NCT number | NCT02802930 |
Other study ID # | 18287 |
Secondary ID | |
Status | Completed |
Phase | N/A |
First received | |
Last updated | |
Start date | April 20, 2015 |
Est. completion date | April 26, 2015 |
Verified date | December 2018 |
Source | Bayer |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 32 |
Est. completion date | April 26, 2015 |
Est. primary completion date | April 26, 2015 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years to 65 Years |
Eligibility |
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 |
Country | Name | City | State |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
---|---|
Bayer |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | up to 1 week | |
Secondary | Number of adverse event as a measure of safety and tolerability | up to 1 week |
Status | Clinical Trial | Phase | |
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