Repeat Insult Patch Test for Daily Advance Cetaphil Moist... | NCT01892423

Studies
Repeat Insult Patch Test for Daily Advance Cetaphil Moisturizing Lotion

NCT01892423

Sponsor

Galderma R&D

Status

Completed

Last Update Posted

Jul 29, 2022Actual

Enrollment

146Actual

Phase

Not Applicable

Conditions

Skin Irritation

Interventions

Cetaphil Moisturizing Lotion Daily Advance

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

Aug 2006

Primary Completion Date

Sep 2006Actual

Completion Date

Not provided

First Submitted Date

Jun 26, 2013

First Submission Date that Met QC Criteria

Jul 1, 2013

First Posted Date

Jul 4, 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

146Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Cetaphil Moisturizing Lotion Daily Advance	Experimental	Each subject had Cetaphil Moisturizing Lotion Daily Advance applied	Other: Cetaphil Moisturizing Lotion Daily Advance

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Cetaphil Moisturizing Lotion Daily Advance	Other		Cetaphil Moisturizing Lotion Daily Advance

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Irritation responses	all patients will be assessed at 14 visits for redness (erythema), spreading, weeping, papules, vesicles, and bullae at application site	average of 5 weeks

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Age 18-65 years
Good health
willingness to cooperate and participate
willingness to avoid topical products at test sites
willingness to avoid direct sun exposure to test sites

Exclusion Criteria:

Individuals with active psoriasis or eczema
individuals with sunburn, acne, abrasions, scar tissue, or tattoos on test sites, or disease of skin that might interfere
individuals who have had a mastectomy with axillary nodes were removed
individuals receiving anticancer, immunosuppressive treatments or medications, or radiation
pregnant, nursing, or planned to become pregnant
use of topical steroids or drugs at test sites
active or untreated skin cancer
active hepatitis
current routine or frequent use of high doses of anti-inflammatory drugs
individuals who have had les than two week rest period since completion of previous patch testing on upper back or upper arms
individuals with uncontrolled metabolic diseases

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

65 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
James H Herndon, MD, FAAD		Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Thomas J Stephens and Associates Inc		Carrollton	Texas	75006	United States