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Clinical Trial Details — Status: Completed

Administrative data

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

Study information

Verified date December 2018
Source Bayer
Contact n/a
Is FDA regulated No
Health authority
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

Study Design


Related Conditions & MeSH terms


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
See also
  Status Clinical Trial Phase
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Completed NCT05004168 - Sun Protection Factor (SPF) / UVA Protection Factor Study N/A
Completed NCT02857738 - Sun Protection Factor (SPF) - Static and Water Resistant Assay N/A
Completed NCT02872246 - Sun Protection Factor (SPF) / UVA Protection Factor (UVAPF) - Assay N/A
Completed NCT02872233 - Sun Protection Factor (SPF) / UVA Protection Factor (UVAPF) Assay N/A
Completed NCT02857725 - Sun Protection Factor (SPF) Assay N/A
Completed NCT02857478 - Supervised Outdoor-Use Test to Assess the Safety of a Sunscreen C-Spray on Sport Users N/A
Completed NCT02885805 - Sun Protection Factor (SPF) Efficacy Assay N/A
Completed NCT02869113 - Evaluation of the Stinging Potential of Sunscreen Products in Human Eyes N/A
Completed NCT02872207 - Evaluation of the Stinging Potential in Human Eyes N/A