Evaluating the Effects of Cleansers on the Skin



Status:Recruiting
Conditions:Psoriasis, Dermatology, Dermatology, Dermatology
Therapuetic Areas:Dermatology / Plastic Surgery
Healthy:No
Age Range:18 - Any
Updated:9/13/2018
Start Date:May 31, 2017
End Date:May 31, 2019

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This will be a single visit study that will take approximately 2 hours. Up to 50 subjects (up
to 25 healthy subjects, and up to 25 subjects with AD) from BUMC dermatology clinics will be
enrolled in this study and randomized to receive the 7 cleansers on 7 test spots on their
upper extremities. One spot will serve as a control and not receive any cleanser. Each spot
will be cleansed with the corresponding cleanser for 15 seconds then rinsed off with tap
water. Skin barrier will be measured at baseline, immediately after, 30, 60 and 90 minutes
after rinse off.

Up to 50 subjects (up to 25 with healthy skin or 25 with atopic dermatitis) meeting the
inclusion criteria will be enrolled in this study. A physical exam will be performed to
ensure the subjects have healthy skin versus atopic dermatitis. For atopic dermatitis
subjects, AD severity will be graded by the EASI score. Site randomization will be performed
to determine which cleansers will be used for each of the 8 test sites (one site will be
randomized to act as a control and not receive any cleanser). Baseline skin barrier function
(TEWL, pH and hydration) will be measured. Then 1ml of each cleansers will be applied to the
corresponding test sites, 2ml of tap water will be added, and lathered in a circular motion
for 15 seconds. The sites will then be rinsed off with tap water for 15 seconds. Arms will be
padded dry. Barrier functions will be measured again immediately after padding dry, and at
30, 60 and 90 minutes after.

Inclusion Criteria:

Male and female, at least 18 years of age Subject must be able to comprehend and read the
English language. Healthy skin without concurrent atopic dermatitis or diagnosed with
atopic dermatitis by a dermatologist

Exclusion Criteria:

Subjects who do not fit the inclusion criteria. Subjects unable to or unwilling to comply
with the study procedures Concurrently have other inflammatory skin conditions. Prior known
allergy to any components to of the cleansers tested A subject who, in the opinion of the
investigator, will be uncooperative or unable to comply with study procedures.

Subject unable to speak or read the English language, since all consents and instructions
will be provided in English.

Those that are prisoners or cognitively impaired
We found this trial at
1
site
7005 North Oracle Road
Tucson, Arizona 85704
Principal Investigator: Vivian Y Shi, MD
Phone: 520-694-1828
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mi
from
Tucson, AZ
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