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| ID | Type | Description | Link |
|---|---|---|---|
| 31963 |
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The purpose of this study is to find out if the use of a hand cleanser that adds moisture to the skin will help improve skin rashes caused by frequent hand washing (hand dermatitis).
The objective of this protocol is to evaluate compatibility and potential benefits of daily use of a marketed mild, moisturizing hand cleanser for subjects/patients who experience mild to moderate hand dermatitis induced by frequent cleansing.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Mild moisturizing Hand Cleanser | Active Comparator | The test group will be provided with a mild moisturizing hand cleanser for all hand cleansing needs during the duration of the study. |
|
| Current Hand Cleanser | No Intervention | The control group will continue to use their current cleanser for all hand washing. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Mild, moisturizing hand cleanser | Other | Hand cleanser ingredient list: Ammonium Lauryl Sulfate, Ammonium Laureth Sulfate, Cocamide MEA, PEG-5 Cocamide Cocamidopropyl Betaine Sodium Lauroyl Sarcosinate Glycerin Petrolatum Soybean Oil Sodium Hydroxypropyl Starch Phosphate Lauric Acid Lauryl Alcohol PEG-14M Guar hydroxypropyl trimonium chloride DMDM Hydantoin; Iodopropynyl Butylcarbamate Etidronic Acid Tetrasodium EDTA Titanium Dioxide Fragrance Sodium Hydroxide Water |
| Measure | Description | Time Frame |
|---|---|---|
| Investigator Global Assessment | Changes in global disease severity on a scale from 0-4 with 0 being clear and 4 being severe | Wk 4 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Alan Fleischer, MD | Wake Forest University Health Sciences | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Wake Forest University Health Sciences Dermatology | Winston-Salem | North Carolina | 27157 | United States |
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Recruitment was from May 22,2007 to May 12, 2008 at Wake Forest University in Winston Salem.
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| ID | Title | Description |
|---|---|---|
| FG000 | Test Product | The test group was provided with a test product for all hand cleansing needs during the duration of the study. |
| FG001 | Control Group (Current Product) | The control group continued to use their current cleanser for hand washing. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Test Product | The test group was provided with a test product for all hand cleansing needs during the duration of the study. |
| BG001 | Control Group (Current Product) | The control group continued to use their current cleanser for hand washing. |
| 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 | Investigator Global Assessment | Changes in global disease severity on a scale from 0-4 with 0 being clear and 4 being severe | Posted | Mean | 95% Confidence Interval | units on a scale | Wk 4 |
|
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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 | Test Product | The test group was provided with a test product for all hand cleansing needs during the duration of the study. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Jamie Regan | Unilever | 203-381-4448 | Jamie.Regan@unilever.com |
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| ID | Term |
|---|---|
| D006229 | Hand Dermatoses |
| ID | Term |
|---|---|
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
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|
| BG002 | Total | Total of all reporting groups |
| Participants |
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| Age, Continuous | Median | Full Range | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| Units |
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| Counts |
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| Participants |
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| 0 |
| 24 |
| 0 |
| 24 |
| EG001 | Control Group (Current Product) | The control group continued to use their current cleanser for hand washing. | 0 | 18 | 0 | 18 |
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