50 Human Subject Repeat Insult Patch Test

Not Applicable

Completed

• Conditions: Erythema; Sensitisation
• Interventions: Other: CB-0002B

• Registration Number: NCT04498676
• Lead Sponsor: 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2017-01-18
• Primary Completion: 2017-02-08
• Study Completion: 2017-03-02
• Status Verified: 2020-07
• Study First Submitted: 2020-07-29
• Study First Submitted QC: 2020-07-31
• Last Update Submitted: 2020-07-31
• Study First Posted: 2020-08-04
• Last Update Posted: 2020-08-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 50

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.

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Test product	CB-0002B	-

Primary Outcome Measures

Name	Time	Method
Erythema	21 days	Erythema rated on a numeric scale from 0 - 4. (0: None; 1: Minimal; 2: Mild; 3: Marked and 4: Severe erythema)
Sensitisation	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

Trial Locations

Locations (1)

AMA Laboratories Inc.; 🇺🇸 New City, New York, United States