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

Allergy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT01816542
• Other study ID #: MC-2013-PT-BA
• Status: Not yet recruiting
• Phase: N/A
• First received: February 12, 2013
• Last updated: March 19, 2013
• Start date: June 2013
• Est. completion date: September 2013

Study information

• Verified date: March 2013
• Source: Mother's Choice Ltd
• Contact: Tova Silberstein, Dr.
• Phone: 972-25610752
• Email: clinical.mc.2013[@]gmail.com
• Is FDA regulated: No
• Health authority: Israel: Ministry of Health
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 100
• Est. completion date: September 2013
• Est. primary completion date: August 2013
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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.

Study Design

Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Screening

Related Conditions & MeSH terms

• Allergy
• Cosmetic Allergy
• Cutaneous Patch
• Dermatitis
• Dermatitis, Contact
• Eczema; Contact, Allergic
• Hypersensitivity

Intervention

Other:
• patch tests on healthy skin
Patches will be placed on healthy skin.

Locations

Country	Name	City	State
Israel	Department of Dermatology, Hadassah University Hospital	Jerusalem

Sponsors (1)

Lead Sponsor	Collaborator
Mother's Choice Ltd

Country where clinical trial is conducted

Israel, 

References & Publications (2)

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. Review. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of participants with positive reactions, number of positive reactions.	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.	One week	Yes
Secondary	Number of irritant versus allergic reactions, as determined by confocal microscopy.	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.	On the spot	No