50 Human Subject Repeat Insult Patch Test

Erythema Clinical Trial

— HRIPT  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04498676
• Other study ID #: MS17.RIPT.P1200O.50.CBIO
• Status: Completed
• Phase: N/A
• Start date: January 18, 2017
• Est. completion date: March 2, 2017

Study information

• Verified date: July 2020
• Source: CAGE Bio Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: March 2, 2017
• Est. primary completion date: February 8, 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 21 Years to 67 Years

Eligibility

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.

Related Conditions & MeSH terms

• Erythema
• Sensitisation

Intervention

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

Locations

Country	Name	City	State
United States	AMA Laboratories Inc.	New City	New York

Sponsors (2)

Lead Sponsor	Collaborator
CAGE Bio Inc.	AMA Laboratories Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Erythema	Erythema rated on a numeric scale from 0 - 4. (0: None; 1: Minimal; 2: Mild; 3: Marked and 4: Severe erythema)	21 days
Primary	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
Primary	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