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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 Description
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Brief Summary:
This study examined the possible sensitization and irritation effects of a moisturizer with sunscreen SPF 50+.

Condition or disease Intervention/treatment Phase
Skin Irritation Drug: Facial Moisturizer with SPF 50+ Phase 4

Detailed Description:
The design for this study is standard for human repeat insult patch tests. To test the moisturizer with sunscreen SPF 50+ for the potential to induce contact sensitization by repetitive applications, healthy subjects received 9 applications at 48 to 72 hour intervals of the moisturizer to the upper back. Patches were remained on the skin for approximately 48 to 72 hours. Twelve to 24 days after the previous applications, subjects were patched with the moisturizer at the original site and an alternative site for 48 hours.
Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 128 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: Cetaphil® Daily Facial Moisturizer With Sunscreen SPF 50+ - Human Repeat Insult Patch Test Skin Irritation/Sensitization Evaluation (Semi-occlusive Patch)
Study Start Date : March 2008
Actual Primary Completion Date : May 2008
Actual Study Completion Date : August 2008

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Sun Exposure
Drug Information available for: Cetaphil

Arms and Interventions
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Arm Intervention/treatment
Experimental: Facial Moisturizer with SPF 50+
All subjects received Cetaphil Daily Facial Moisturizer with SPF 50+
 Drug: Facial Moisturizer with SPF 50+
All subjects received applications of occlusive patches dosed with Cetaphil Daily Facial Moisturizer with SPF 50+
Other Name: Cetaphil Daily Facial Moisturizer with SPF 50+


Outcome Measures
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Primary Outcome Measures :
  1. Area of Erythema and Elevated Responses of Skin to Product [ Time Frame: 3 consecutive weeks ]
    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.


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Men or women 18 to 70 years of age in general good health
  • Can read, understand, and sign informed consent

Exclusion Criteria:

  • History of acute or chronic disease
  • Diagnosed with chronic skin allergies
  • Pregnant or lactating
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01892657


Locations
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United States, Colorado
Thomas J. Stephens and Associates, Inc.
Colorado Springs, Colorado, United States, 89015
Sponsors and Collaborators
Galderma Laboratories, L.P.
Investigators
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Study Director: Ronald Gottschalk, MD Galderma Laboratories, L.P.
More Information
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Responsible Party: Galderma Laboratories, L.P.
ClinicalTrials.gov Identifier: NCT01892657    
Other Study ID Numbers: GLI.04.SRE.US10093
First Posted: July 4, 2013    Key Record Dates
Results First Posted: September 25, 2013
Last Update Posted: September 25, 2013
Last Verified: August 2008
Keywords provided by Galderma Laboratories, L.P.:
Cetaphil Daily Facial Moisturizer with SPF 50+
Hypoallergenicity
Skin Irritation