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50 Human Subject Repeat Insult Patch Test (HRIPT)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04498676
Recruitment Status : Completed
First Posted : August 4, 2020
Last Update Posted : August 4, 2020
Sponsor:
Collaborator:
AMA Laboratories Inc.
Information provided by (Responsible Party):
CAGE Bio Inc.

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.

Condition or disease Intervention/treatment Phase
Erythema Sensitisation Other: CB-0002B Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 50 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Screening
Official Title: 50 Human Subject Repeat Insult Patch Test Skin Irritation/Sensitization Evaluation (Occlusive Patch)
Actual Study Start Date : January 18, 2017
Actual Primary Completion Date : February 8, 2017
Actual Study Completion Date : March 2, 2017

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




Primary Outcome Measures :
  1. 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)

  2. 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

  3. 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



Information from the National Library of Medicine

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Ages Eligible for Study:   21 Years to 67 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04498676


Locations
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United States, New York
AMA Laboratories Inc.
New City, New York, United States, 10956
Sponsors and Collaborators
CAGE Bio Inc.
AMA Laboratories Inc.
Investigators
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Study Director: Director AMA Laboratories Inc.
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Responsible Party: CAGE Bio Inc.
ClinicalTrials.gov Identifier: NCT04498676    
Other Study ID Numbers: MS17.RIPT.P1200O.50.CBIO
First Posted: August 4, 2020    Key Record Dates
Last Update Posted: August 4, 2020
Last Verified: July 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by CAGE Bio Inc.:
HRIPT
irritant
Additional relevant MeSH terms:
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Erythema
Skin Diseases
Skin Manifestations