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Trial record 37 of 568 for:    applied AND irritation

Cetaphil® Daily Facial Moisturizer With Sunscreen SPF 50+ - Human Repeat Insult Patch Test

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ClinicalTrials.gov Identifier: NCT01892657
Recruitment Status : Completed
First Posted : July 4, 2013
Results First Posted : September 25, 2013
Last Update Posted : September 25, 2013
Sponsor:
Information provided by (Responsible Party):
Galderma Laboratories, L.P.

Study Type Interventional
Study Design Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Supportive Care
Condition Skin Irritation
Intervention Drug: Facial Moisturizer with SPF 50+
Enrollment 128
Recruitment Details Subjects were screened at a single US center.
Pre-assignment Details  
Arm/Group Title Facial Moisturizer With SPF 50+
Hide Arm/Group Description All subjects received Cetaphil Daily Facial Moisturizer with SPF 50+
Period Title: Overall Study
Started 128
Completed 110
Not Completed 18
Reason Not Completed
Withdrawal by Subject             6
Protocol Violation             12
Arm/Group Title Facial Moisturizer With SPF 50+
Hide Arm/Group Description All subjects received Cetaphil Daily Facial Moisturizer with SPF 50+
Overall Number of Baseline Participants 110
Hide Baseline Analysis Population Description
All subjects who were enrolled in the study and participated in all scheduled visits during the study were analyzed.
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 110 participants
<=18 years
0
   0.0%
Between 18 and 65 years
109
  99.1%
>=65 years
1
   0.9%
Age Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 110 participants
44.0  (13.68)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 110 participants
Female
86
  78.2%
Male
24
  21.8%
Race/Ethnicity, Customized  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 110 participants
African American 10
Asian 3
Caucasian 71
Hispanic 23
Caucasian/Hispanic 3
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 110 participants
110
1.Primary Outcome
Title Area of Erythema and Elevated Responses of Skin to Product
Hide Description Subjects were patched 9 times at 48 hour to 72 hour intervals and graded for erythema and elevated responses (edema, papules, vesicles, bullae) on a 4 point scale (0 = none, 1 = mild, 2 = moderate, 3 = severe). 12 to 24 hours after the last patch application, a challenge patch was applied at the same site and a challenge patch was applied to an alternate site. Both were graded for the same criteria at 48 hours and at 96 hours. A total of 11 patches were applied to each subject. All patches were removed after 48 hours.
Time Frame 3 consecutive weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Patch 1 Patch 2 Patch 3 Patch 4 Patch 5 Patch 6 Patch 7 Patch 8 Patch 9 Challenge Patch (Original Site) - 48 Hours Challenge Patch (Original Site) - 96 Hours Challenge Patch (Alternate Site) - 48 Hours Challenge Patch (Alternate Site) - 96 Hours
Hide Arm/Group Description:
Subjects received a patch dosed with 100 microliters of Cetaphil Daily Facial Moisturizer with SPF 50+
Subjects received a patch dosed with 100 microliters of Cetaphil Daily Facial Moisturizer with SPF 50+
Subjects received a patch dosed with 100 microliters of Cetaphil Daily Facial Moisturizer with SPF 50+
Subjects received a patch dosed with 100 microliters of Cetaphil Daily Facial Moisturizer with SPF 50+
Subjects received a patch dosed with 100 microliters of Cetaphil Daily Facial Moisturizer with SPF 50+
Subjects received a patch dosed with 100 microliters of Cetaphil Daily Facial Moisturizer with SPF 50+
Subjects received a patch dosed with 100 microliters of Cetaphil Daily Facial Moisturizer with SPF 50+
Subjects received a patch dosed with 100 microliters of Cetaphil Daily Facial Moisturizer with SPF 50+
Subjects received a patch dosed with 100 microliters of Cetaphil Daily Facial Moisturizer with SPF 50+
The challenge patch dosed with 100 microliters of Cetaphil Daily Facial Moisturizer with SPF 50+ applied to the original application site was graded at 48 hours.
The challenge patch dosed with 100 microliters of Cetaphil Daily Facial Moisturizer with SPF 50+ applied to the original application site was graded again at 96 hours.
A challenge patch dosed with 100 microliters of Cetaphil Daily Facial Moisturizer with SPF 50+ applied to an alternate application site was graded at 48 hours.
A challenge patch dosed with 100 microliters of Cetaphil Daily Facial Moisturizer with SPF 50+ applied to an alternate application site was graded again at 96 hours.
Overall Number of Participants Analyzed 110 110 110 110 110 110 110 110 110 110 110 110 110
Measure Type: Number
Unit of Measure: participants
None 91 68 33 42 39 20 33 33 23 78 85 86 95
Mild 19 41 72 68 69 82 72 72 78 31 24 23 12
Moderate 0 1 5 0 2 8 5 5 9 1 1 1 3
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Facial Moisturizer With SPF 50+
Hide Arm/Group Description All subjects received Cetaphil Daily Facial Moisturizer with SPF 50+
All-Cause Mortality
Facial Moisturizer With SPF 50+
Affected / at Risk (%)
Total   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Facial Moisturizer With SPF 50+
Affected / at Risk (%)
Total   0/110 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Facial Moisturizer With SPF 50+
Affected / at Risk (%)
Total   0/110 (0.00%) 
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Name/Title: Elizabeth M. Nieman, Medical Information Specialist
Organization: Galderma Laboratories, L.P.
Phone: 817-961-5130
Responsible Party: Galderma Laboratories, L.P.
ClinicalTrials.gov Identifier: NCT01892657     History of Changes
Other Study ID Numbers: GLI.04.SRE.US10093
First Submitted: July 1, 2013
First Posted: July 4, 2013
Results First Submitted: July 23, 2013
Results First Posted: September 25, 2013
Last Update Posted: September 25, 2013