FiteBac Hand Sanitizer in the Management of Hand Dermatitis in Adults

• 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

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