Repeat Insult Patch Test of Skin Irritation/Sensitization... | NCT01888887

Studies
Repeat Insult Patch Test of Skin Irritation/Sensitization for Cetaphil Daily Facial Cleanser

NCT01888887

Sponsor

Galderma R&D

Status

Completed

Last Update Posted

Jul 29, 2022Actual

Enrollment

200Actual

Phase

Not Applicable

Conditions

Skin Irritation

Interventions

Cetaphil Daily Facial Cleanser

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

Jun 2013

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

Dec 2012

Primary Completion Date

Feb 2013Actual

Completion Date

Not provided

First Submitted Date

Jun 26, 2013

First Submission Date that Met QC Criteria

Jun 26, 2013

First Posted Date

Jun 28, 2013Estimated

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 28, 2022

Last Update Posted Date

Jul 29, 2022Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

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

200Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Cetaphil Daily Facial Cleanser	Experimental	All subjects receive Cetaphil Daily Facial Cleanser	Other: Cetaphil Daily Facial Cleanser

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Cetaphil Daily Facial Cleanser	Other		Cetaphil Daily Facial Cleanser

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
area of erythema and edema to test reaction of skin to product	9 consecutive 24hr exposures for every Monday, Wednesday, and Friday for 3 consecutive weeks will be conducted to test the reaction of the skin to the test product	3 consecutive weeks

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Not currently under a doctor's care
Free of dermatological or systemic disorder which would interfere with the results
Free of any acute or chronic disease
Will complete a preliminary medical history form and are in general good health
Can read, understand, and sign informed consent

Exclusion Criteria:

Under 18 years old
Currently under doctor's care
Currently taking any medication
History of acute or chronic disease
Diagnosed with chronic skin allergies
Pregnant or lactating

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Mayya Tastene, MD	AMA Laboratories, Inc.	Principal Investigator

Locations

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