Evaluation of Irritancy/Allergic Sensitivity to Natural Personal-care Products by Patch Tests
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT01816542|
Recruitment Status : Unknown
Verified March 2013 by Mother's Choice Ltd.
Recruitment status was: Not yet recruiting
First Posted : March 22, 2013
Last Update Posted : March 22, 2013
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||Not Applicable|
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 Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||100 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|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 :||June 2013|
|Estimated Primary Completion Date :||August 2013|
|Estimated Study Completion Date :||September 2013|
|patch tests on healthy skin||
Other: patch tests on healthy skin
Patches will be placed on healthy skin.
- Number of participants with positive reactions, number of positive reactions. [ Time Frame: 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.
- Number of irritant versus allergic reactions, as determined by confocal microscopy. [ Time Frame: 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01816542
|Contact: Tova Silberstein, Dr.||firstname.lastname@example.org|
|Contact: Liran Horev, MD||972-26776366|
|Department of Dermatology, Hadassah University Hospital||Not yet recruiting|
|Jerusalem, Israel, 91120|
|Principal Investigator:||Arieh Ingber, MD Prof.||Hadassah University Hospital, Department of Dermatology|
|Principal Investigator:||Liran Horev, MD||Hadassah University Hospital, Department of Dermatology|