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Study Reference No. - C3F02910

Demographic Gender Age Location Compensation
Healthy with Fitzpatrick I-VI Female and Male 18-65 Winnipeg, MB $310.00
Study Details

Study Purpose

The purpose of this study is to determine the moisturization (hydration) potential of personal care products (personal skin cleansing products) by visual evaluation for dryness and erythema (redness/rash) in combination with non-invasive instrumental measurements for hydration and skin barrier following a product application phase of controlled once daily washes over a 1-week period under normal use conditions. Approximately 70 participants will participate in the conditioning phase of the study and of these, approximately 48 healthy female and male participants, ages 18 through 65 of Fitzpatrick skin type I - VI (scale I to VI will depend on your skin tone as after winter, during the first 45 – 60 minutes of sun exposure without sunscreen), will participate in the product application phase of the study. Note: Non-invasive means no introduction of any instrument into the body. ”Instrumentation” or “instrument” means readings will be taken by using different electronic devices [called Corneometer, Skicon and TEWL]. The instruments do not penetrate the skin; they rest on the surface of the skin and are painless.

Study Duration

Total 8 Visits
Screening, Product Application and assessment Phase

Study Schedule

General Screening

-

Medical Screening

N/A

Study Visit(s)

Visit 1 (Approx. 1 hour) [07/MAR/23]
Informed Consent, Medical history review, inclusion/exclusion questions, soap distribution and instructions

Visit 2 (Approx. 1.5 hours) [12/MAR/23]
This visit will take approximately 1.5 hours. At visit 2, you will sit quietly (no reading, music or talking) for at least 20 minutes in a climate-controlled room (temperature approximately 66°F -74°F [approximately 18°C - 23°C] and 30%-55% relative humidity) with your sites exposed (sleeves rolled up) and an evaluator will examine your lower inner forearms for dryness and erythema (redness/rash). You may be disqualified if your arms are too dry or not dry enough. If you qualify for the study, six test sites, each 3 cm  3 cm, will be marked on your lower inner forearms– three on each lower inner forearm. These test sites may be re-marked continuously throughout the study. Please do not remove these marks until after the study is complete. Following visual assessments, instrumental readings will then be taken from each test site to measure moisture in the skin (Corneometer and Skicon), and moisture evaporating from the skin (TEWL). After instrumental readings, you will go to the wash area. A technician will wash 6 test sites with test products.

Visit 3 to Visit 7 (Approx. 45 minutes) [13/MAR/23] to [17/MAR/23]
Each visit will take approximately 45 minutes. You will come to Cliantha Research once per day (including weekends) depending upon the appointment time for Visit 3 to Visit 8 (Day 2 to Day 6). At each visit, a technician will check your lower inner forearms for any signs of irritation before product application. During all visits, 6 test sites will receive a wash of test products.

Visit 8 (Approx. 1.5 hours) [18/MAR/23]
This visit will take approximately 1.5 hours. At visit 8, you will sit quietly (no reading, music or talking) for at least 20 minutes in a climate-controlled room with your test sites exposed and an evaluator will examine your lower inner forearms for dryness and erythema (redness/rash). Following visual assessments, instrumental readings (Corneometer, Skicon and TEWL) will then be taken from each test site.

Follow-Up Visit(s)

N/A

Other Notes

Bring valid ID