- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07564869
Skin Hydration and Facial Aging in Women Aged 30-60: An Observational Correlational Study Using Bioimpedance Analysis (SHFA-30-60)
Skin Hydration and Facial Aging: A Cross-Sectional Correlational Observational Study Using BT-Analyze Bioimpedance Assessment Across Seven Facial Zones in Women Aged 30-60 Years
Study Overview
Status
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
-
-
Florida
-
Winter Garden, Florida, United States, 34787
- IAS Skin Care
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion Criteria:
Female, aged 30 to 60 years Willing to attend one study visit without makeup No cosmetics applied for at least 4 hours prior to the visit Able to acclimate in controlled indoor environment for 20 minutes Signed written informed consent
Exclusion Criteria:
Active dermatological conditions (eczema, psoriasis, rosacea in flare) Injectable cosmetic procedures within the past 6 months Systemic medications affecting skin condition (oral retinoids, systemic corticosteroids) Pregnancy or lactation Uncontrolled systemic conditions known to significantly affect skin (e.g., uncontrolled diabetes mellitus)
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
Group 1 - Ages 30-40
Women aged 30 to 40 years (n=10)
|
Non-invasive skin hydration measurement using BT-Analyze bioimpedance device at seven standardized facial zones.
No therapeutic intervention is administered.
|
|
Group 2 - Ages 40-50
Women aged 40 to 50 years (n=10)
|
Non-invasive skin hydration measurement using BT-Analyze bioimpedance device at seven standardized facial zones.
No therapeutic intervention is administered.
|
|
Group 3 - Ages 50-60
Women aged 50 to 60 years (n=10)
|
Non-invasive skin hydration measurement using BT-Analyze bioimpedance device at seven standardized facial zones.
No therapeutic intervention is administered.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Spearman Correlation Between BT-Analyze Mean Score and Modified Glogau Visual Aging Score
Time Frame: At single study visit (Day 1)
|
Spearman rank correlation coefficient (rs) between mean BT-Analyze hydration score (mean of seven facial zones, 0-65 units) and total modified Glogau visual aging score (0-18 points) assessed by a blinded expert cosmetologist.
|
At single study visit (Day 1)
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
BT-Analyze Score Comparison Across Age Groups
Time Frame: At single study visit (Day 1)
|
Kruskal-Wallis comparison of mean BT-Analyze hydration scores between three age groups (30-40, 40-50, 50-60 years).
|
At single study visit (Day 1)
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
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
Other Study ID Numbers
- IAS-SKIN-2026-001
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
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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