Irritant Contact Dermatitis Clinical Trial
Official title:
Prospective Single Center Randomized Double Blind Controlled Tolerability Trial of Six Hair Cleansing Conditioners
Hair cleansing product tolerability study
Study Aim: The objective of this study is to evaluate the tolerability of daily use of f hair
cleansing products.
Background/Study Rational/Significance: There have been consumer reports of irritancy and
hair loss with use of Wen cleansing conditioner. A recent study of 142 patients found no
increase in hair loss when used in normal subjects, however skin assessments for tolerability
were not evaluated.
Methodology: This double-blind, randomized, controlled clinical trial will evaluate the
tolerability of six hair cleansing products including Wen cleansing conditioner using two
standard clinical and research methods, Repeat Open Application Tests (ROAT) (a test for
irritancy) and Semi-Open Patch Tests (a test for allergenicity). For the ROAT, participants
will apply the hair cleansing products to 6 separate locations on the forearm using a
standardized, protocol and scored using a 10-point scale. Application site of each cleansing
product will be randomized. Exposure time will be increased in a step-wise fashion over 5
weeks. Participants and investigators will be blinded to location of products. The primary
outcome is intolerance; intolerance will be defined as 1) ROAT skin component scoring >6 (of
10 maximum) or 2) ROAT global score of >4 (of 5 maximum). If intolerance to a specific
product is reached, the ROAT for that product will be discontinued. . Clinical assessments
(global scoring and component scoring) will be performed at 0, 2, and 4 and 5 weeks. Primary
outcomes will be measured at 5 weeks. Allergenicity is a secondary outcome and will be
assessed with semi-open patch tests to the 6 hair cleansing products performed at week 4 and
read at week 5
Setting/ patients: Single center study of 200 patients. To represent a broad spectrum of skin
barrier function, recruitment will target enrollment of 150 individuals with a no history of
childhood eczema (non-atopic) and 50 individuals with a history of childhood eczema (atopic).
Population: Men and women over the age of 18 years old.
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