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

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

Detailed Description
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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.

Official Title
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Cetaphil® Daily Facial Moisturizer With Sunscreen SPF 50+ - Human Repeat Insult Patch Test Skin Irritation/Sensitization Evaluation (Semi-occlusive Patch)

Conditions
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Skin Irritation

Intervention / Treatment
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* Drug: Facial Moisturizer with SPF 50+


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Facial Moisturizer with SPF 50+<br>All subjects received Cetaphil Daily Facial Moisturizer with SPF 50+ | Drug: Facial Moisturizer with SPF 50+<br>* All subjects received applications of occlusive patches dosed with Cetaphil Daily Facial Moisturizer with SPF 50+<br>* Other names: Cetaphil Daily Facial Moisturizer with SPF 50+;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Area of Erythema and Elevated Responses of Skin to Product | 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. | 3 consecutive weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Cetaphil Daily Facial Moisturizer with SPF 50+, Hypoallergenicity, Skin Irritation