Clinical trial NCT01816542: Evaluation of Irritancy/Allergic Sensitivity to Natural Personal-care Products by Patch Tests
Official title: Dermatologically Tested - Patch Tests - to Assess the Irritancy/Allergic Sensitivity of the Natural Personal-care Products Developed by "Mother's Choice".
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Cutaneous Patch
Dermatitis
Allergy
Cosmetic Allergy
Eczema; Contact, Allergic
Keywords: patch-testing
personal-care
cosmetic
dermatitis
allergy
sensitive skin
Lead sponsor: Mother's Choice Ltd
Sponsor class: INDUSTRY
First posted: 2013-03-22
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SCREENING

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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Number of participants with positive reactions, number of positive reactions.
timeFrame: One week
Secondary outcomes:
measure: Number of irritant versus allergic reactions, as determined by confocal microscopy.
timeFrame: On the spot
Other outcomes:
Locations:
city: Jerusalem
country: Israel
facility: Department of Dermatology, Hadassah University Hospital
Study officials:
affiliation: Hadassah University Hospital, Department of Dermatology
name: Arieh Ingber, MD Prof.
role: PRINCIPAL_INVESTIGATOR
affiliation: Hadassah University Hospital, Department of Dermatology
name: Liran Horev, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Mahmood T, Akhtar N. Short term study of human skin irritation by single application closed patch test: assessment of four multiple emulsion formulations loaded with botanical extracts. Cutan Ocul Toxicol. 2013 Mar;32(1):35-40. doi: 10.3109/15569527.2012.700472. Epub 2012 Jul 5.
citation: Davies RF, Johnston GA. New and emerging cosmetic allergens. Clin Dermatol. 2011 May-Jun;29(3):311-5. doi: 10.1016/j.clindermatol.2010.11.010.