Allergy Clinical Trial - Evaluation of Irritancy/Allergic Sensitivity to

Status Not yet recruiting

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.

Clinical Trial 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. ;

Study Design

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

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT01816542
Study type	Interventional
Source	Mother's Choice Ltd
Contact	Tova Silberstein, Dr.
Phone	972-25610752
Email	clinical.mc.2013@gmail.com
Status	Not yet recruiting
Phase	N/A
Start date	June 2013
Completion date	September 2013

View Details

See also
Status	Clinical Trial	Phase
Terminated	`NCT02032056` - Effect of Probiotics in Reducing Infections and Allergies in Young Children During the Complementary Feeding Period	N/A
Completed	`NCT01842711` - Cumulative Irritation Patch Test	N/A
Completed	`NCT01633840` - New Validated Recipes for Double-blind Placebo-controlled Low Dose Food Challenges	N/A
Completed	`NCT00554983` - Efficacy and Safety From a Recombinant Folding Variant of Bet v 1	Phase 3
Completed	`NCT00997971` - Growth, Tolerance in Healthy Infants Fed a Partially Hydrolyzed Rice Protein	Phase 3
Completed	`NCT00331929` - Respiratory Health Study of Children in Kiryat Tivon	N/A
Completed	`NCT00220753` - Air Cleaners for Children and Adolescents With Asthma and Dog Allergy	N/A
Completed	`NCT00232518` - Randomised Controlled Clinical Trials of the Effect of Therapeutic Hookworm Infection in Allergic Rhinoconjunctivitis	N/A
Completed	`NCT04126096` - Negative Predictive Value and NIC of Beta-Lactam Antibiotics.	N/A
Completed	`NCT04046731` - Neuromuscular Blocking Agents Utilized During Perioperative Hypersensitivity Evaluation	N/A
Completed	`NCT04004351` - Treatment Modalities in Children and Adolescents Suffering From HDM-induced Allergic Rhinitis and/or Asthma
Not yet recruiting	`NCT05997784` - Study of Indoor Air Pollutants and Their Impact in Childhood Health and Wellbeing
Completed	`NCT04418999` - Safety and Efficacy of Intracanalicular Dexamethasone Compared to Loteprednol Etabonate in Patients With Keratoconus	Early Phase 1
Completed	`NCT04186949` - Early Origins of Allergy and Asthma
Completed	`NCT02127801` - Single Ascending-dose Study of the Efficacy, Safety, Tolerability, and Pharmacokinetics of REGN1908-1909 in Allergic, Adult Participants	Phase 1
Enrolling by invitation	`NCT05011071` - The Alberta BLOOM Premature Child Study
Not yet recruiting	`NCT06330974` - Allergy, Asthma, and Atopic Eczema in Finland
Completed	`NCT02596321` - A Study Investigating the Immunologic Effects and Safety of 60-day Treatment of the ALK HDM Tablets in Adult Subjects With HDM-Induced Allergic Rhinitis and/or Atopic Asthma	Phase 3
Terminated	`NCT02601690` - Observational Analysis of T Cell Responses to SPIREs for Multiple Allergens in Subjects With Allergy in North America
Completed	`NCT02306473` - The Leaky Lung Test	Early Phase 1

Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

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

Clinical Trial Summary

Clinical Trial Description

Study Design

Related Conditions & MeSH terms