FiteBac Hand Sanitizer in the Management of Hand Dermatitis in Adults
Condition: Hand Dermatitis
MeSH terms: Dermatitis
Study type: Interventional

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

Intervention name(s): fiteBac Hand Sanitizer
Intervention type(s): Other
Intervention description(s): 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.
Other intervention name(s): Brand name: fiteBac Hand Sanitizer
Intervention MeSH terms: Hand Sanitizers
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: hand dermatitis; health care workers; hand sanitizer