50 Human Subject Repeat Insult Patch Test | NCT04498676

Studies
50 Human Subject Repeat Insult Patch Test

NCT04498676

Sponsor

CAGE Bio Inc.

Status

Completed

Last Update Posted

Aug 4, 2020Actual

Enrollment

50Actual

Phase

Not Applicable

Conditions

Erythema
Sensitisation

Interventions

CB-0002B

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jul 2020

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 18, 2017Actual

Primary Completion Date

Feb 8, 2017Actual

Completion Date

Mar 2, 2017Actual

First Submitted Date

Jul 29, 2020

First Submission Date that Met QC Criteria

Jul 31, 2020

First Posted Date

Aug 4, 2020Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jul 31, 2020

Last Update Posted Date

Aug 4, 2020Actual

Name	Class
AMA Laboratories, Inc.	INDUSTRY

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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 provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

50Actual

Label	Type	Description	Intervention Names
Test product	Experimental		Other: CB-0002B

Name	Type	Description	Arm Group Labels	Other Names
CB-0002B	Other	CB-0002B (choline geranate) is a viscous transparent colorless to light yellow liquid	Test product

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility 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.

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

21 Years

Maximum Age

67 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Name	Affiliation	Role
Director	AMA Laboratories, Inc.	Study Director

Facility	Status	City	State	ZIP	Country	Contacts
AMA Laboratories Inc.		New City	New York	10956	United States

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

ID	Term
D012871	Skin Diseases
D017437	Skin and Connective Tissue Diseases
D012877	Skin Manifestations
D012816	Signs and Symptoms