Evaluation of Irritancy/Allergic Sensitivity to Natural Personal-care Products by Patch Tests
Dermatologically Tested - Patch Tests - to Assess the Irritancy/Allergic Sensitivity of the Natural Personal-care Products Developed by "Mother's Choice".
1 other identifier
interventional
100
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Jun 2013
Shorter than P25 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
February 12, 2013
CompletedFirst Posted
Study publicly available on registry
March 22, 2013
CompletedStudy Start
First participant enrolled
June 1, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2013
CompletedStudy Completion
Last participant's last visit for all outcomes
September 1, 2013
CompletedMarch 22, 2013
March 1, 2013
2 months
February 12, 2013
March 19, 2013
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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
Secondary Outcomes (1)
Number of irritant versus allergic reactions, as determined by confocal microscopy.
On the spot
Study Arms (1)
patch tests on healthy skin
OTHERInterventions
Eligibility Criteria
You may qualify if:
- \- Healthy adults
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Department of Dermatology, Hadassah University Hospital
Jerusalem, 91120, Israel
Related Publications (2)
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.
PMID: 22765292BACKGROUNDDavies 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.
PMID: 21496740BACKGROUND
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Arieh Ingber, MD Prof.
Hadassah University Hospital, Department of Dermatology
- PRINCIPAL INVESTIGATOR
Liran Horev, MD
Hadassah University Hospital, Department of Dermatology
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- SCREENING
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 12, 2013
First Posted
March 22, 2013
Study Start
June 1, 2013
Primary Completion
August 1, 2013
Study Completion
September 1, 2013
Last Updated
March 22, 2013
Record last verified: 2013-03