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

This study is not yet open for participant recruitment. (see Contacts and Locations)
Verified March 2013 by Mother's Choice Ltd
Sponsor:
Information provided by (Responsible Party):
Mother's Choice Ltd
ClinicalTrials.gov Identifier:
NCT01816542
First received: February 12, 2013
Last updated: March 19, 2013
Last verified: March 2013
  Purpose

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 Intervention
Cutaneous Patch
Dermatitis
Allergy
Cosmetic Allergy
Eczema; Contact, Allergic
Other: patch tests on healthy skin

Study Type: Interventional
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".

Resource links provided by NLM:


Further study details as provided by Mother's Choice Ltd:

Primary Outcome Measures:
  • 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.



Secondary Outcome Measures:
  • 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.


Estimated Enrollment: 100
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)
Arms Assigned Interventions
patch tests on healthy skin Other: patch tests on healthy skin
Patches will be placed on healthy skin.

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

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01816542

Contacts
Contact: Tova Silberstein, Dr. 972-25610752 clinical.mc.2013@gmail.com
Contact: Liran Horev, MD 972-26776366

Locations
Israel
Department of Dermatology, Hadassah University Hospital Not yet recruiting
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
  More Information

Publications:
Responsible Party: Mother's Choice Ltd
ClinicalTrials.gov Identifier: NCT01816542     History of Changes
Other Study ID Numbers: MC-2013-PT-BA
Study First Received: February 12, 2013
Last Updated: March 19, 2013
Health Authority: Israel: Ministry of Health

Keywords provided by Mother's Choice Ltd:
patch-testing
personal-care
cosmetic
dermatitis
allergy
sensitive skin

Additional relevant MeSH terms:
Dermatitis
Hypersensitivity
Dermatitis, Contact
Skin Diseases
Immune System Diseases
Skin Diseases, Eczematous

ClinicalTrials.gov processed this record on September 18, 2014