50 Human Subject Repeat Insult Patch Test

NCT ID: NCT04498676

Last Updated: 2020-08-04

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-01-18

Study Completion Date

2017-03-02

Brief Summary

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Consumer products or raw materials designed for consistent reapplication to areas of the skin may, under proper conditions, prove to be contact sensitizers or irritants in certain individuals. It is the intention of a Repeat Insult Patch Test (RIPT) to provide a basis for evaluation of this irritation/sensitization potential if such exists.

Detailed Description

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Conditions

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Erythema Sensitisation

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

SCREENING

Blinding Strategy

NONE

Study Groups

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Test product

Group Type EXPERIMENTAL

CB-0002B

Intervention Type OTHER

CB-0002B (choline geranate) is a viscous transparent colorless to light yellow liquid

Interventions

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CB-0002B

CB-0002B (choline geranate) is a viscous transparent colorless to light yellow liquid

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* Individuals who are not currently under a doctor's care
* Individuals free of any dermatological or systemic disorder which would interfere with the results, at the discretion of the Investigator.
* Individuals free of any acute or chronic disease that might interfere with or increase the risk of study participation.
* Individuals who will complete a preliminary medical history form mandated by AMA Laboratories, Inc. and are in general good health.
* Individuals, who will read, understand and sign an informed consent document relating to the specific type of study they are subscribing. Consent forms are kept on file and are available for examination on the premises of AMA Laboratories, Inc. only.
* Individuals able to cooperate with the Investigator and research staff, willing to have test materials applied according to the protocol, and complete the full course of the study.

Exclusion Criteria

* Individuals under 18 years of age.
* Individuals who are currently under a doctor's care.
* Individuals who are currently taking any medication (topical or systemic) that may mask or interfere with the test results.
* Subjects with a history of any acute or chronic disease that might interfere with or increase the risk associated with study participation.
* Individuals diagnosed with chronic skin allergies.
* Female volunteers who indicate that they are pregnant or lactating.
Minimum Eligible Age

21 Years

Maximum Eligible Age

67 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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AMA Laboratories Inc.

UNKNOWN

Sponsor Role collaborator

CAGE Bio Inc.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Director

Role: STUDY_DIRECTOR

AMA Laboratories Inc.

Locations

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AMA Laboratories Inc.

New City, New York, United States

Site Status

Countries

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United States

Other Identifiers

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MS17.RIPT.P1200O.50.CBIO

Identifier Type: -

Identifier Source: org_study_id

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