Allergy Clinical Trial
Official title:
Dermatologically Tested - Patch Tests - to Assess the Irritancy/Allergic Sensitivity of the Natural Personal-care Products Developed by "Mother's Choice".
The purpose of the study is to determine if any of Mother's Choice' all-natural
personal-care products cause either irritation or allergic reaction when applied to both
normal or sensitive skin.
Each product will be tested on the skin using patch tests.
Volunteers will be seen on Day #0 and the study purpose will be explained. Each volunteer
will be interviewed to determine if he/she has any exclusion criteria.
If there is no contraindication, and agreement is achieved,consent forms will be signed.
Volunteers will be examined by a lactic acid test to determine if he/she has normal or
sensitive skin. In this test, a Finn's cell (plastic cell, size 1*1 cm) with lactic acid (50
microliter, 10%w/v) will be placed on the volunteer's cheek for ten minutes. The volunteer
will be defined as "sensitive" or "normal" according to the degree of discomfort they
report.
Patch-tests will be performed in the standard method. The materials to be tested will be
placed in Finn's cells and attached to the participants healthy skin's back by a plaster
(Micropore).The chambers will be left on the skin for 48 hours. The test will be read by a
specialist one hour after chambers' removal and 48 hours afterwards. Any erythema,edema,
blisters, pustules or erosions on the skin in the patch area will be considered a positive
response, and will be evaluated by clinical tools as being of the irritant or the allergic
type. in case of uncertainty we may use a confocal microscope for in vivo diagnosis.
Ingredients: appropriate concentrations and solvents of the test materials will be prepared
according to accepted standards (refer to: Anton C. De Groot: Patch Testing, 3ed Edition,
Wapserveen, The Netherlands, 2009).Leave on products will be tested 'as is'. Rinse off
products will be diluted to 5% and 0.5%.
If the skin stays normal after the patch removal, it means that contact with the material
did not cause allergy or irritation.
;
Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Screening
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