Evaluation of Irritancy/Allergic Sensitivity to Natural Personal-care Products by Patch Tests
Recruitment status was: Not yet recruiting
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.
Eczema; Contact, Allergic
Other: patch tests on healthy skin
|Study Design:||Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: 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".|
- Number of participants with positive reactions, number of positive reactions. [ Time Frame: One week ] [ Designated as safety issue: Yes ]
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 ] [ Designated as safety issue: No ]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.
|Study Start Date:||June 2013|
|Estimated Study Completion Date:||September 2013|
|Estimated Primary Completion Date:||August 2013 (Final data collection date for primary outcome measure)|
|patch tests on healthy skin||
Other: patch tests on healthy skin
Patches will be placed on healthy skin.
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01816542
|Department of Dermatology, Hadassah University Hospital|
|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|