50 Human Subject Repeat Insult Patch Test (HRIPT)

July 31, 2020 updated by: CAGE Bio Inc.

50 Human Subject Repeat Insult Patch Test Skin Irritation/Sensitization Evaluation (Occlusive Patch)

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 Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

50

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • New York
      • New City, New York, United States, 10956
        • AMA Laboratories Inc.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

21 years to 67 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: SCREENING
  • Allocation: NA
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Test product
Other: CB-0002B
CB-0002B (choline geranate) is a viscous transparent colorless to light yellow liquid

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Erythema
Time Frame: 21 days
Erythema rated on a numeric scale from 0 - 4. (0: None; 1: Minimal; 2: Mild; 3: Marked and 4: Severe erythema)
21 days
Sensitisation
Time Frame: 24 hours
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
24 hours
Sensitisation
Time Frame: 48 hours
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
48 hours

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

CAGE Bio Inc.

Collaborators

AMA Laboratories Inc.

Investigators

  • Study Director: Director, AMA Laboratories Inc.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

January 18, 2017

Primary Completion (ACTUAL)

February 8, 2017

Study Completion (ACTUAL)

March 2, 2017

Study Registration Dates

First Submitted

July 29, 2020

First Submitted That Met QC Criteria

July 31, 2020

First Posted (ACTUAL)

August 4, 2020

Study Record Updates

Last Update Posted (ACTUAL)

August 4, 2020

Last Update Submitted That Met QC Criteria

July 31, 2020

Last Verified

July 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MS17.RIPT.P1200O.50.CBIO

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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