check_circleStudy Completed

Sunscreening Agents

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

Trial purpose

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

Key Participants Requirements

Sex

Both

Age

18 - 45 Years
  • - 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.

  • - 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.

Trial summary

Enrollment Goal
72
Trial Dates
January 2017 - January 2017
Phase
N/A
Could I Receive a placebo
No
Products
BAY987517
Accepts Healthy Volunteer
Yes

Where to participate

StatusInstitutionLocation
Completed
Memphis, 38112, United States

Primary Outcome

  • Feeling any discomfort after applying the product assessed by questionnaire
    date_rangeTime Frame:
    15 minutes after each application
    enhanced_encryption
    Safety Issue:
    Yes

Trial design

Evaluation of a Gel Sunscreen in Controlled Use Conditions
Trial Type
Interventional
Intervention Type
Drug
Trial Purpose
Prevention
Allocation
N/A
Blinding
Single Blind
Assignment
Single Group Assignment
Trial Arms
1