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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-06-30

Study Completion Date

2013-09-30

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.

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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.

Conditions

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Cutaneous Patch Dermatitis Allergy Cosmetic Allergy Eczema; Contact, Allergic

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

SCREENING

Blinding Strategy

NONE

Study Groups

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patch tests on healthy skin

Group Type OTHER

patch tests on healthy skin

Intervention Type OTHER

Patches will be placed on healthy skin.

Interventions

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patch tests on healthy skin

Patches will be placed on healthy skin.

Intervention Type OTHER

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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes