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This study examined the possible sensitization and irritation effects of a moisturizer with sunscreen SPF 50+.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Facial Moisturizer with SPF 50+ | Experimental | All subjects received Cetaphil Daily Facial Moisturizer with SPF 50+ |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Facial Moisturizer with SPF 50+ | Drug | All subjects received applications of occlusive patches dosed with Cetaphil Daily Facial Moisturizer with SPF 50+ |
|
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Ronald Gottschalk, MD | Galderma R&D | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Thomas J. Stephens and Associates, Inc. | Colorado Springs | Colorado | 89015 | United States |
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Subjects were screened at a single US center.
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| ID | Title | Description |
|---|---|---|
| FG000 | Facial Moisturizer With SPF 50+ | All subjects received Cetaphil Daily Facial Moisturizer with SPF 50+ |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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All subjects who were enrolled in the study and participated in all scheduled visits during the study were analyzed.
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| ID | Title | Description |
|---|---|---|
| BG000 | Facial Moisturizer With SPF 50+ | All subjects received Cetaphil Daily Facial Moisturizer with SPF 50+ |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | Posted | Number | participants | 3 consecutive weeks |
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Facial Moisturizer With SPF 50+ | All subjects received Cetaphil Daily Facial Moisturizer with SPF 50+ |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Elizabeth M. Nieman, Medical Information Specialist | Galderma Laboratories, L.P. | 817-961-5130 | elizabeth.nieman@galderma.com |
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|
| Participants |
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| Age, Continuous | Mean | Standard Deviation | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Race/Ethnicity, Customized | Number | Participants |
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| Region of Enrollment | Number | participants |
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Subjects received a patch dosed with 100 microliters of Cetaphil Daily Facial Moisturizer with SPF 50+ |
| OG002 | Patch 3 | Subjects received a patch dosed with 100 microliters of Cetaphil Daily Facial Moisturizer with SPF 50+ |
| OG003 | Patch 4 | Subjects received a patch dosed with 100 microliters of Cetaphil Daily Facial Moisturizer with SPF 50+ |
| OG004 | Patch 5 | Subjects received a patch dosed with 100 microliters of Cetaphil Daily Facial Moisturizer with SPF 50+ |
| OG005 | Patch 6 | Subjects received a patch dosed with 100 microliters of Cetaphil Daily Facial Moisturizer with SPF 50+ |
| OG006 | Patch 7 | Subjects received a patch dosed with 100 microliters of Cetaphil Daily Facial Moisturizer with SPF 50+ |
| OG007 | Patch 8 | Subjects received a patch dosed with 100 microliters of Cetaphil Daily Facial Moisturizer with SPF 50+ |
| OG008 | Patch 9 | Subjects received a patch dosed with 100 microliters of Cetaphil Daily Facial Moisturizer with SPF 50+ |
| OG009 | Challenge Patch (Original Site) - 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 at 48 hours. |
| OG010 | Challenge Patch (Original Site) - 96 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. |
| OG011 | Challenge Patch (Alternate Site) - 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 at 48 hours. |
| OG012 | Challenge Patch (Alternate Site) - 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 again at 96 hours. |
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| 0 |
| 110 |
| 0 |
| 110 |
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