50 Human Subject Repeat Insult Patch Test

CAGE Bio Inc.50 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

SCREENING

Masking

NONE

Enrollment

Conditions

Erythema Sensitisation

Interventions

CB-0002BOTHER

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

Eligibility

Sex: ALLMin age: 21 YearsMax age: 67 YearsHealthy volunteers:

Medical Language ↔ Plain English

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.

Locations (1)

AMA Laboratories Inc.

New City, New York, United States

Outcomes

Primary Outcomes

Erythema

Erythema rated on a numeric scale from 0 - 4. (0: None; 1: Minimal; 2: Mild; 3: Marked and 4: Severe erythema)

Time frame: 21 days

Sensitisation

After a 10-14 day rest period, a challenge test was given at a different skin site to look for signals of a sensitization response measured by rating erythema on a scale from 0 - 4

Time frame: 24 hours

Sensitisation

After a 10-14 day rest period, a challenge test was given at a different skin site to look for signals of a sensitization response measured by rating erythema on a scale from 0 - 4

Time frame: 48 hours

Data from ClinicalTrials.gov

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