50 Human Subject Repeat Insult Patch Test

Study Overview
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Brief Summary
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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.

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

Conditions
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Erythema, Sensitisation

Intervention / Treatment
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* Other: CB-0002B


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 21 Years
Maximum Age: 67 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Screening
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Test product<br> | Other: CB-0002B<br>* CB-0002B (choline geranate) is a viscous transparent colorless to light yellow liquid<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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HRIPT, irritant