Trial Condition(s):
Sunscreen agents
Test the phototoxicity of sunscreen products
Bayer Identifier:
18287
ClinicalTrials.gov Identifier:
EudraCT Number:
Not Available
EU CT Number:
Not Available
Trial Purpose
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.
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
Exclusion Criteria
No Exclusion Criteria Available
Trial Summary
Enrollment Goal
Trial Dates
Phase
Could I receive a placebo?
Products
Accepts Healthy Volunteers
Where to Participate
| Locations | Status | |
|---|---|---|
Locations Investigative Site Pinellas Park, United States, 33781 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Trial Design
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
Trial Type:
Interventional
Intervention Type:
Drug
Trial Purpose:
Other
Allocation:
N/A
Blinding:
Single Blind
Assignment:
Single Group Assignment
Trial Arms:
1
Primary Outcome
- Skin irritationSkin irritation was rated on a scale from 0-7 where 0 is no evidence of irritation and 7 is strong reaction spreading beyond test siteTimeframe: up to 1 week
Secondary Outcome
- Number of adverse event as a measure of safety and tolerabilityTimeframe: up to 1 week
Additional Information
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