Back to resultsPatch Test Skin Irritation/Sensitization of Cetaphil Daily Advance Ultra Hydration Lotion
Primary Purpose
Determine Sensitivity of Skin to Cetaphil Daily Advance Ultra Hydrating Lotion
Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Cetaphil Daily Advance Ultra Hydrating Lotion
Sponsored by
About this trial
This is an interventional supportive care trial for Determine Sensitivity of Skin to Cetaphil Daily Advance Ultra Hydrating Lotion
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
Sites / Locations
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Cetaphil Daily Advance Ultra Hydrating Lotion
Arm Description
All subjects receive Cetaphil Daily Advance Ultra Hydrating Lotion
Outcomes
Primary Outcome Measures
area of erythema and edema is measured
9 consecutive 24hr exposures for every Monday, Wednesday, and Friday for 3 consecutive weeks
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01885130
Brief Title
Patch Test Skin Irritation/Sensitization of Cetaphil Daily Advance Ultra Hydration Lotion
Official Title
100 Human Subject Repeat Insult Patch Test Skin Irritation/Sensitization Evaluation (Occlusive Patch)
Study Type
Interventional
2. Study Status
Record Verification Date
June 2013
Overall Recruitment Status
Completed
Study Start Date
December 2012 (undefined)
Primary Completion Date
January 2013 (Actual)
Study Completion Date
undefined (undefined)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Galderma R&D
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
Determine if Cetaphil Daily Advance Ultra Hydrating Lotion proves to be a contact sensitizer or irritant in certain individuals.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Determine Sensitivity of Skin to Cetaphil Daily Advance Ultra Hydrating Lotion
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
100 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Cetaphil Daily Advance Ultra Hydrating Lotion
Arm Type
Experimental
Arm Description
All subjects receive Cetaphil Daily Advance Ultra Hydrating Lotion
Intervention Type
Other
Intervention Name(s)
Cetaphil Daily Advance Ultra Hydrating Lotion
Intervention Description
0.2ml or 0.2g of Cetaphil on occlusive, hypoallergenic patch applied to skin for 24 hrs 9 times on Monday, Wednesday, and Friday for 3 weeks
Primary Outcome Measure Information:
Title
area of erythema and edema is measured
Description
9 consecutive 24hr exposures for every Monday, Wednesday, and Friday for 3 consecutive weeks
Time Frame
3 consecutive weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mayya Tastene, MD
Organizational Affiliation
AMA Laboratories
Official's Role
Principal Investigator
12. IPD Sharing Statement
Learn more about this trial
Patch Test Skin Irritation/Sensitization of Cetaphil Daily Advance Ultra Hydration Lotion
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