- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07764809
Driving Time and Facial Skin Hydration Asymmetry in Florida Drivers (DCHA-FL-25-65)
Driving Time and Left-Cheek Skin Hydration Asymmetry in Florida Residents: An Observational Study on Cumulative UVA Exposure Through Vehicle Side Windows
his observational study examines whether time spent driving is associated with differences in skin hydration between the left and right cheeks in female drivers residing in Florida. In left-hand-drive vehicles, the driver's left cheek is chronically exposed to ultraviolet A (UVA) radiation through the unshaded side window during every daytime driving episode. A prior study by IAS Skin Care (NCT07564869, n=30) found that the left cheek was less hydrated than the right cheek in 60% of participants, suggesting a possible effect of driving-related UVA exposure on facial skin hydration asymmetry.
Eighty female drivers aged 25-65 years residing in Florida will be enrolled. At a single visit, skin hydration will be measured at three facial zones (left cheek, right cheek, and forehead as a symmetrical control zone) using the BT-Analyze bioimpedance device. Participants will complete a structured questionnaire on driving habits, sun protection practices, and skin history. The primary outcome is the Hydration Asymmetry Index (HAI = right cheek minus left cheek BT-Analyze score). Associations between driving time, cumulative driving exposure, window tinting, sunscreen use, and HAI will be examined using Spearman correlation, Mann-Whitney U tests, and multiple linear regression.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Estimated)
Contacts and Locations
Study Contact
- Name: Olga IAS, M.Sc
- Phone Number: 689-249-26-77
- Email: ias.skincare1@gmail.com
Study Locations
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Florida
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Orlando, Florida, United States, 32835
- IAS Skin Care
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Contact:
- Olga IAS, M.Sc
- Phone Number: 689-249-2677
- Email: ias.skincare1@gmail.com
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion Criteria:
- Female sex, aged 25 to 65 years (inclusive)
- Valid driver's license and active driving for a minimum of 3 years
- Driving frequency of at least 3 days per week on average
- Florida residency for a minimum of 2 years prior to enrollment
- Ability to provide written informed consent in English or Russian
Exclusion Criteria:
- Window tinting on the driver-side window of the participant's primary vehicle
- Regular sunscreen application specifically to the left side of the face before driving (more than half of driving occasions in the past month)
- Active skin disease on the face at time of assessment
- Injectable cosmetic procedures (Botox or fillers) in the past 6 months
- Laser resurfacing or chemical peel in the past 3 months
- Inability to refrain from facial cosmetics for at least 2 hours prior to the visit
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
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Female Florida Drivers
Female drivers aged 25-65 years residing in Florida for at least two years, driving at least 3 days per week, without window tinting on the driver-side window.
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Non-invasive skin hydration measurement at three facial zones (right cheek, left cheek, forehead) using the BT-Analyze bioimpedance device.
Three measurements per zone.
Single visit.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Hydration Asymmetry Index (HAI)
Time Frame: Single visit (Day 1)
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Difference in mean BT-Analyze bioimpedance scores between the right and left cheeks (HAI = right cheek mean minus left cheek mean).
A positive value indicates lower hydration on the left cheek relative to the right.
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Single visit (Day 1)
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Correlation between cumulative driving exposure and HAI
Time Frame: Single visit (Day 1)
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Spearman correlation between cumulative driving exposure index (years of driving × hours per week) and the Hydration Asymmetry Index.
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Single visit (Day 1)
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HAI by window tinting status
Time Frame: Single visit (Day 1)
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Comparison of Hydration Asymmetry Index between participants with tinted versus untinted driver-side windows, assessed by Mann-Whitney U test.
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Single visit (Day 1)
|
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HAI by sunscreen application habit
Time Frame: Single visit (Day 1)
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Comparison of Hydration Asymmetry Index between participants who regularly apply sunscreen to the left side of the face before driving and those who do not, assessed by Mann-Whitney U test.
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Single visit (Day 1)
|
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Forehead hydration as symmetry reference
Time Frame: Single visit (Day 1)
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Forehead BT-Analyze score used as a bilateral symmetry reference zone to confirm that observed cheek asymmetry is directional and not attributable to general hydration differences.
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Single visit (Day 1)
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Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- IAS-SKIN-2026-002
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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