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| ID | Type | Description | Link |
|---|---|---|---|
| Fite Bac Hand Sanitizer | Other Identifier | FiteBac Hand Sanitizer |
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Hand dermatitis, (a rash, or eczema, on the hands) is a common skin condition that affects approximately 10% of the population. It can be caused by a wide variety of things, such as allergens or irritants. For some, it can be painful and disfiguring. In moderate to severe cases, hand dermatitis can interfere greatly in the quality of life of the affected person, interfering with work and social functions. This can have a negative psychological effect as well.
FiteBac Skin Care Gel is a new over-the-counter hand sanitizer that has been used for hospital and dental hand infection control. This product contains a germicide, to prevent infection. It also contains a silicone polymer. This makes the hand gel more durable, causing it to remain on the skin longer. Despite this durability, the hand gel still allows the skin to naturally perspire (sweat).
As people in the health-care industry have used this new product with the goal of reducing hand infections, it has been noted that FiteBac Skin Care Gel also seems to have reduced hand dermatitis and improved personal skin condition. The purpose of this study is to scientifically measure skin improvement in a population of study subjects with hand dermatitis.
3.2.3. Exclusion criteria
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| fiteBac Hand Sanitizer | Experimental | Blinded fitBac Hand sanitizer |
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| Blinded emollient therapy | Placebo Comparator | Blinded emollient therapy |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| fiteBac Hand Sanitizer | Other | Skin gel created for health care workers that is currently on the market. This sanitizer has an additive layer to protect the skin that is also thought to helpo hand dermatitis. |
| Measure | Description | Time Frame |
|---|---|---|
| Efficacy of fiteBac compared to emollient therapy | - To compare the efficacy of fiteBac skin care versus emollient therapy using standardized questionnaires, physical findings and photography over a one month treatment period in adults with hand dermatitis. | 1 month |
| Measure | Description | Time Frame |
|---|---|---|
| Bacterial counts | - To compare the bacterial counts on the hands of patients with hand dermatitis treated with one month of fiteBac skin care versus emollient therapy | 1 month |
| Physician Global Assessment |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Donald Leung, MD, PhD | National Jewish Health | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| National Jewish Health | Denver | Colorado | 80206 | United States |
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- To determine the Physician Global Assessment (PGA) of overall hand dermatitis severity with excellent response defined as clear or almost clear hands
| 1 month |
| Adverse events | - Number of adverse events on fiteBac versus emollient control | 1 month |
| Number of flares | - To determine the number of flares on fiteBac versus emollient control | 1 month |
| Number of study discontinuations | - To determine the number of study discontinuations on fiteBac versus emollient control | 1 month |
| Patients Global Assessment score | - To determine the Patient's Global Assessment score on fiteBac versus emollient control | 1 month |