Sunscreening Agents
Conditions
Brief summary
To visually evaluate the retention of coverage of the Test Product(s) (TP) on the face after exercise compared to the full coverage observed prior to exercise
Interventions
DRUGBAY987517
Sunscreen formula Y65-158
Sponsors
Bayer
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 55 Years
Healthy volunteers
Yes
Inclusion criteria
Subjects may be male or female, of an age of 18-55 years inclusive. Subjects must be capable of understanding and providing written informed consent. Subjects must sign a written confidentiality agreement including a photography release form. Subjects must be in good general health as judged by a specified licensed physician, who will indicate their suitability to participate in this study.
Exclusion criteria
Subjects must not have received or used an Investigational New Drug within the last 30 days. Subjects must not have been active participants in another clinical or subjective TP performance study within the last 30 days unless authorized by this Sponsor. Subjects must not have a known physical or medical condition that would preclude vigorous exercise Subjects must not have a five-minute resting pulse rate greater than 80 bpm.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change of face coverage post exercise compared to the full coverage observed prior to exercise (in percent) | At baseline, and post exercise (30 minutes) | The expert grader will determine the percentage of coverage achieved by viewing the subject's face through the Skin Scanner |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Report of eye stinging assessed by questionnaire | Up to 30 minutes | Subjective assessment of eye stinging (where 0=none to 4=severe) |
Countries
United States
Outcome results
None listed