Test the Phototoxicity of Sunscreen Products

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02802930
• Other study ID #: 18287
• Status: Completed
• Phase: N/A
• Start date: April 20, 2015
• Est. completion date: April 26, 2015

Study information

• Verified date: December 2018
• Source: Bayer
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• 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

Related Conditions & MeSH terms

• Dermatitis, Phototoxic
• Sunscreen Agents

Intervention

Drug:
• SPF 50 Y65 110 (BAY987519)
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.
• SPF 50 Y51 002 (BAY987519)
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.
• SPF 15 V27 104 (BAY987519)
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.
• Sodium chloride [NaCl]
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).

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Bayer

Country where clinical trial is conducted

United States, 

Outcome

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

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