Clinical trial NCT01950494: FiteBac Hand Sanitizer in the Management of Hand Dermatitis in Adults
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hand Dermatitis
Keywords: hand dermatitis
health care workers
hand sanitizer
Lead sponsor: National Jewish Health
Sponsor class: OTHER
First posted: 2013-09-25
Enrollment: 22
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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

Eligibility criteria: Inclusion Criteria:

1. Males or females, 18-70 years of age, in generally good health with no significant underlying systemic disease requiring ongoing medications.
2. Hand eczema severity index (HECSI) with a score of greater than 50 (see Table 1 and reference 5)
3. 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:

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

Primary outcomes:
measure: Efficacy of fiteBac compared to emollient therapy
timeFrame: 1 month
Secondary outcomes:
measure: Bacterial counts
timeFrame: 1 month
measure: Physician Global Assessment
timeFrame: 1 month
measure: Adverse events
timeFrame: 1 month
measure: Number of flares
timeFrame: 1 month
measure: Number of study discontinuations
timeFrame: 1 month
measure: Patients Global Assessment score
timeFrame: 1 month
Other outcomes:
Locations:
city: Denver
country: United States
facility: National Jewish Health
state: Colorado
Study officials:
affiliation: National Jewish Health
name: Donald Leung, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: