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OpenTrials
Completed

NCT Number: NCT03012347

Evaluation of a Gel Sunscreen in Controlled Use Conditions (208/2016)

To explore and quantify potential issues with application of a gel sunscreen in Outdoor Use testing, in a controlled indoor environment

Completed

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Key information

Conditions

Sunscreening Agents

Age range

18 year–45 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Memphis, Tennessee, 38112, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Subjects may be male or female.
  • Subjects must be adults between 18 and 45 years of age.
  • Subjects must have and have had a consistently active lifestyle for at least the previous few years (exercise
  • outdoors and in direct sun exposure at least 2 times per week for at least 30 minutes-acceptable activities include tennis, running, jogging, walking, golf, etc.), i.e., outdoor activity should not be a new behavior.
  • Subjects must have used a sunscreen with SPF 50 or higher within the previous 9 months.

Exclusion criteria

  • Subjects who have received or used an Investigational New Drug within the last 30 days.
  • Subjects who have been active participants in another clinical or subjective product performance study within the last 30 days.
  • Subjects who have a known allergy or sensitivity to sunscreen ingredients or test materials.
  • Subjects with respiratory allergies or asthma.

Treatment and study plan

BAY987517

Drug

Subjects will be instructed to apply the test article in a split-body and face configuration, to the assigned side of the body (face, arms, torso, and legs), as they normally would before going outdoors for a run, walk or other sport related activity. (Formulation: RB# Y73-161)

BullFrog Gel Sunscreen Land Sport SPF-50

Drug

Subjects will be instructed to apply the test article in a split-body and face configuration, to the assigned side of the body (face, arms, torso, and legs), as they normally would before going outdoors for a run, walk or other sport related activity.

Primary outcomes

  1. Feeling any discomfort after applying the product assessed by questionnaire

    Time frame: 15 minutes after each application

Sponsors and collaborators

Lead sponsor

Bayer

Industry

Registry information

Official study title

Evaluation of a Gel Sunscreen in Controlled Use Conditions

Important dates

Study start
2017
Primary completion
2017
Study completion
2017
First posted
Jan 6, 2017
Registry last updated
Dec 7, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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