Evaluation of Irritancy/Allergic Sensitivity to Natural Personal-care Products by Patch Tests

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Dermatologically Tested - Patch Tests - to Assess the Irritancy/Allergic Sensitivity of the Natural Personal-care Products Developed by Mother's Choice.

Conditions
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Cutaneous Patch, Dermatitis, Allergy, Cosmetic Allergy, Eczema; Contact, Allergic

Intervention / Treatment
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* Other: patch tests on healthy skin


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: - Healthy adults Exclusion Criteria: Pregnant subjects Subjects with an allergy or a skin disease which interferes with the proper results of the tests. Subjects who are taking medications which can interfere with the proper results of the tests. For example: systemic corticosteroids, topical steroids applied to the test area. Subjects with sun or phototherapy induced tanning at the test area. Subject who had been participating in allergy tests within eight weeks prior to the present tests.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Screening
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: patch tests on healthy skin<br> | Other: patch tests on healthy skin<br>* Patches will be placed on healthy skin.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of participants with positive reactions, number of positive reactions. | Erythema, edema, blisters, pustules or erosions on the skin in the patch area will be considered a positive response. If the skin is normal after the patch removal, it means that contact with the material do not cause allergy or irritation. | One week | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of irritant versus allergic reactions, as determined by confocal microscopy. | In case of a positive reaction, it will be examined by confocal microscopy, by a specialist, to determine whether the reaction is irritant or allergic in nature. | On the spot | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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patch-testing, personal-care, cosmetic, dermatitis, allergy, sensitive skin