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

Sponsor

Mother's Choice Ltd (Industry)

Overall Status

Unknown status

CT.gov ID

NCT01816542

Collaborator

(none)

100

Enrollment

Location

Arm

Duration (Months)

33.1

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
Cutaneous Patch Dermatitis Allergy Cosmetic Allergy Eczema; Contact, Allergic	Other: patch tests on healthy skin	N/A

Detailed Description

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.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

100 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Screening

Official Title:

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

Study Start Date :

Jun 1, 2013

Anticipated Primary Completion Date :

Aug 1, 2013

Anticipated Study Completion Date :

Sep 1, 2013

Arms and Interventions

Arm	Intervention/Treatment
Other: patch tests on healthy skin	Other: patch tests on healthy skin Patches will be placed on healthy skin.

Arm

Intervention/Treatment

Other: patch tests on healthy skin

Other: patch tests on healthy skin

Patches will be placed on healthy skin.

Outcome Measures

Primary Outcome Measures

Number of participants with positive reactions, number of positive reactions. [One week]
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.

Secondary Outcome Measures

Number of irritant versus allergic reactions, as determined by confocal microscopy. [On the spot]
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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 65 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Department of Dermatology, Hadassah University Hospital	Jerusalem		Israel	91120

Sponsors and Collaborators

Mother's Choice Ltd

Investigators

Principal Investigator: Arieh Ingber, MD Prof., Hadassah University Hospital, Department of Dermatology
Principal Investigator: Liran Horev, MD, Hadassah University Hospital, Department of Dermatology