Test the Phototoxicity of Sunscreen Products

Bayer

Status: Completed

Conditions: Sunscreen Agents

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

Study type: Interventional

Funder types: Industry

Identifiers

NCT02802930

18287

Details and patient eligibility

About

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.

Enrollment: 32 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion 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

Trial design

Primary purpose: Other

Allocation: N/A

Interventional model: Single Group Assignment

Masking: Single Blind

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32 participants in 1 patient group

SPF 50 Y65 110, SPF 50 Y51 002, and SPF 15 V27 104

Experimental group

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.

Treatment:

Drug: Sodium chloride [NaCl]

Drug: SPF 15 V27 104 (BAY987519)

Drug: SPF 50 Y51 002 (BAY987519)

Drug: SPF 50 Y65 110 (BAY987519)