- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01887860
Patch Test Skin Irritation/Sensitization of Cetaphil Daily Facial Moisturizer SPF 50
July 28, 2022 updated by: Galderma R&D
Subject Repeat Insult Patch Test Skin Irritation/Sensitization Evaluation (Occlusive Patch)
Determine if Cetaphil Daily Facial Moisturizer SPF 50 proves to be a contact sensitizer or irritant in certain individuals.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
100
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
New York
-
New City, New York, United States, 10956
- AMA Laboratories
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Cetaphil Daily Facial Moisturizer SPF50
All subjects receive Cetaphil Daily Facial Moisturizer SPF 50
|
Other: Cetaphil Daily Advance Ultra Hydrating Lotion 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
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Area of erythema and edema measured
Time Frame: 3 consecutive weeks
|
9 consecutive 24hr exposures for every Monday, Wednesday, and Friday for 3 consecutive weeks
|
3 consecutive weeks
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
December 1, 2012
Primary Completion (Actual)
January 1, 2013
Study Registration Dates
First Submitted
June 24, 2013
First Submitted That Met QC Criteria
June 26, 2013
First Posted (Estimate)
June 27, 2013
Study Record Updates
Last Update Posted (Actual)
July 29, 2022
Last Update Submitted That Met QC Criteria
July 28, 2022
Last Verified
June 1, 2013
More Information
Terms related to this study
Other Study ID Numbers
- GLI.04.SRE.US10232c
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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