FiteBac Hand Sanitizer in the Management of Hand Dermatitis in Adults
| Status: | Completed |
|---|---|
| Conditions: | Dermatology |
| Therapuetic Areas: | Dermatology / Plastic Surgery |
| Healthy: | No |
| Age Range: | 18 - 70 |
| Updated: | 2/7/2015 |
| Start Date: | September 2013 |
| End Date: | September 2015 |
| Contact: | Jami Henriksen |
| Email: | henriksenj@njhealth.org |
| Phone: | 303-398-1233 |
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
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.
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.
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
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
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
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