Back to results50 Human Subject Repeat Insult Patch Test (HRIPT)
Primary Purpose
Erythema, Sensitisation
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
CB-0002B
Sponsored by
About this trial
This is an interventional screening trial for Erythema focused on measuring HRIPT, irritant
Eligibility Criteria
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.
Sites / Locations
- AMA Laboratories Inc.
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Test product
Arm Description
Outcomes
Primary Outcome Measures
Erythema
Erythema rated on a numeric scale from 0 - 4. (0: None; 1: Minimal; 2: Mild; 3: Marked and 4: Severe erythema)
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
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
Secondary Outcome Measures
Full Information
NCT ID
NCT04498676
First Posted
July 29, 2020
Last Updated
July 31, 2020
Sponsor
CAGE Bio Inc.
Collaborators
AMA Laboratories Inc.
1. Study Identification
Unique Protocol Identification Number
NCT04498676
Brief Title
50 Human Subject Repeat Insult Patch Test
Acronym
HRIPT
Official Title
50 Human Subject Repeat Insult Patch Test Skin Irritation/Sensitization Evaluation (Occlusive Patch)
Study Type
Interventional
2. Study Status
Record Verification Date
July 2020
Overall Recruitment Status
Completed
Study Start Date
January 18, 2017 (Actual)
Primary Completion Date
February 8, 2017 (Actual)
Study Completion Date
March 2, 2017 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
CAGE Bio Inc.
Collaborators
AMA Laboratories Inc.
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Erythema, Sensitisation
Keywords
HRIPT, irritant
7. Study Design
Primary Purpose
Screening
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
50 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Test product
Arm Type
Experimental
Intervention Type
Other
Intervention Name(s)
CB-0002B
Intervention Description
CB-0002B (choline geranate) is a viscous transparent colorless to light yellow liquid
Primary Outcome Measure Information:
Title
Erythema
Description
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
Title
Sensitisation
Description
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
Title
Sensitisation
Description
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
10. Eligibility
Sex
All
Minimum Age & Unit of Time
21 Years
Maximum Age & Unit of Time
67 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Director
Organizational Affiliation
AMA Laboratories Inc.
Official's Role
Study Director
Facility Information:
Facility Name
AMA Laboratories Inc.
City
New City
State/Province
New York
ZIP/Postal Code
10956
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
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50 Human Subject Repeat Insult Patch Test
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