NCT02802930

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
32

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Apr 2015

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 20, 2015

Completed
6 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 26, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 26, 2015

Completed
1.1 years until next milestone

First Submitted

Initial submission to the registry

June 14, 2016

Completed
2 days until next milestone

First Posted

Study publicly available on registry

June 16, 2016

Completed
Last Updated

December 12, 2018

Status Verified

December 1, 2018

Enrollment Period

6 days

First QC Date

June 14, 2016

Last Update Submit

December 11, 2018

Conditions

Sunscreen Agents

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (1)

  • Number of adverse event as a measure of safety and tolerability

    up to 1 week

Study Arms (1)

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

EXPERIMENTAL

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.

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

Interventions

SPF 50 Y65 110 (BAY987519)DRUG

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 Y65 110, SPF 50 Y51 002, and SPF 15 V27 104
SPF 50 Y51 002 (BAY987519)DRUG

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 50 Y65 110, SPF 50 Y51 002, and SPF 15 V27 104
SPF 15 V27 104 (BAY987519)DRUG

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 50 Y65 110, SPF 50 Y51 002, and SPF 15 V27 104
Sodium chloride [NaCl]DRUG

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).

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

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Unknown Facility

Pinellas Park, Florida, 33781, United States

Location

MeSH Terms

Interventions

Sodium Chloride

Intervention Hierarchy (Ancestors)

ChloridesHydrochloric AcidChlorine CompoundsInorganic ChemicalsSodium Compounds

Study Officials

  • Bayer Study Director

    Bayer

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
OTHER
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 14, 2016

First Posted

June 16, 2016

Study Start

April 20, 2015

Primary Completion

April 26, 2015

Study Completion

April 26, 2015

Last Updated

December 12, 2018

Record last verified: 2018-12

Locations

US(1)