50 Human Subject Repeat Insult Patch Test

NCT04498676 | Completed

• 1 other identifier: MS17.RIPT.P1200O.50.CBIO
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

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.

Conditions

Erythema; Sensitisation

Keywords

HRIPT; irritant

Outcome Measures

Primary Outcomes (3)

• Erythema

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

  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

  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

  48 hours

Study Arms (1)

Test product

EXPERIMENTAL

Other: CB-0002B

Interventions

CB-0002B OTHER

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

Test product

Eligibility Criteria

• Age: 21 Years - 67 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• CAGE Bio Inc.: lead
• AMA Laboratories Inc.: collaborator

Study Sites (1)

AMA Laboratories Inc.

New City, New York, 10956, United States

Location

MeSH Terms

Conditions

Erythema

Condition Hierarchy (Ancestors)

Skin Diseases; Skin and Connective Tissue Diseases; Skin Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Director

  AMA Laboratories Inc.

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SCREENING
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 29, 2020
• First Posted: August 4, 2020
• Study Start: January 18, 2017
• Primary Completion: February 8, 2017
• Study Completion: March 2, 2017
• Last Updated: August 4, 2020

Record last verified: 2020-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)