FiteBac Hand Sanitizer in the Management of Hand Dermatitis in Adults

Study Overview
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Brief Summary
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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.

Detailed Description
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Informed consent must be signed and understood by subject. Symptoms and history consistent with hand dermatitis based on symptoms and clinical history (as described in refs 4-7). Males or females, 18-70 years of age, in generally good health with no significant underlying systemic disease requiring ongoing medications. Hand eczema severity index (HECSI) with a score of greater than 50 (see Table 1 and reference 5) Physician global assessment (PGA) of moderate to severe (with PGA severity scores graded as in Table 1 of reference 8: severe, moderate, mild, almost clear, clear). 3.2.3. Exclusion criteria Topical corticosteroid or calcineurin inhibitor treatment during the last 7 days, prior to enrollment, on the hands and forearms Systemic treatment with corticosteroids or other immunosuppressives during the last 14 days. Subjects currently receiving (or received during the previous 4 weeks) other investigational drugs, treatments or devices, or participating in another clinical study. Treatment with ultraviolet (UV) light (including tanning) during the previous 4 weeks. Acute dermatitis outbreak on the arms or hands. Subjects unable to comply with protocol restrictions Subjects known to be unreliable or non-compliant with medical treatment, or unwilling to comply with multiple return visits. Any condition or prior/present treatment, in the opinion of the investigators, should render the patient ineligible for the study Known allergy to benzalkonium chloride or other ingredients in the fiteBac vehicle

Official Title
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A One Month, Randomized, Two-center, Parallel-group, Double-blind,Placebo-controlled Study to Evaluate the Efficacy and Safety of FiteBac Hand Sanitizer TID vs Emollient Therapy in the Management of Hand Dermatitis in Adults

Conditions
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Hand Dermatitis

Intervention / Treatment
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* Other: fiteBac Hand Sanitizer


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Males or females, 18-70 years of age, in generally good health with no significant underlying systemic disease requiring ongoing medications. Hand eczema severity index (HECSI) with a score of greater than 50 (see Table 1 and reference 5) Physician global assessment (PGA) of moderate to severe (with PGA severity scores graded as in Table 1 of reference 8: severe, moderate, mild, almost clear, clear). Exclusion Criteria: Topical corticosteroid or calcineurin inhibitor treatment during the last 7 days, prior to enrollment, on the hands and forearms Systemic treatment with corticosteroids or other immunosuppressives during the last 14 days. Subjects currently receiving (or received during the previous 4 weeks) other investigational drugs, treatments or devices, or participating in another clinical study. Treatment with ultraviolet (UV) light (including tanning) during the previous 4 weeks. Acute dermatitis outbreak on the arms or hands. Subjects unable to comply with protocol restrictions Subjects known to be unreliable or non-compliant with medical treatment, or unwilling to comply with multiple return visits. Any condition or prior/present treatment, in the opinion of the investigators, should render the patient ineligible for the study Known allergy to benzalkonium chloride or other ingredients in the fiteBac vehicle

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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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: fiteBac Hand Sanitizer<br>Blinded fitBac Hand sanitizer | Other: fiteBac Hand Sanitizer<br>* 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.<br>* Other names: Brand name: fiteBac Hand Sanitizer;|
| Placebo Comparator: Blinded emollient therapy<br>Blinded emollient therapy | Other: fiteBac Hand Sanitizer<br>* 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.<br>* Other names: Brand name: fiteBac Hand Sanitizer;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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 | - 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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hand dermatitis, health care workers, hand sanitizer