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FiteBac Hand Sanitizer in the Management of Hand Dermatitis in Adults (FiteBac)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01950494
Recruitment Status : Completed
First Posted : September 25, 2013
Last Update Posted : January 5, 2017
Sponsor:
Information provided by (Responsible Party):
Donald Leung, MD, PhD, National Jewish Health

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.


Condition or disease Intervention/treatment Phase
Hand Dermatitis Other: fiteBac Hand Sanitizer Not Applicable

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

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 22 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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 Start Date : September 2013
Actual Primary Completion Date : July 2014
Actual Study Completion Date : July 2014

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: fiteBac Hand Sanitizer
Blinded fitBac Hand sanitizer
Other: fiteBac Hand Sanitizer
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 Name: Brand name: fiteBac Hand Sanitizer

Placebo Comparator: Blinded emollient therapy
Blinded emollient therapy
Other: fiteBac Hand Sanitizer
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 Name: Brand name: fiteBac Hand Sanitizer




Primary Outcome Measures :
  1. Efficacy of fiteBac compared to emollient therapy [ Time Frame: 1 month ]
    - 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.


Secondary Outcome Measures :
  1. Bacterial counts [ Time Frame: 1 month ]
    - To compare the bacterial counts on the hands of patients with hand dermatitis treated with one month of fiteBac skin care versus emollient therapy

  2. Physician Global Assessment [ Time Frame: 1 month ]
    - To determine the Physician Global Assessment (PGA) of overall hand dermatitis severity with excellent response defined as clear or almost clear hands

  3. Adverse events [ Time Frame: 1 month ]
    - Number of adverse events on fiteBac versus emollient control

  4. Number of flares [ Time Frame: 1 month ]
    - To determine the number of flares on fiteBac versus emollient control

  5. Number of study discontinuations [ Time Frame: 1 month ]
    - To determine the number of study discontinuations on fiteBac versus emollient control

  6. Patients Global Assessment score [ Time Frame: 1 month ]
    - To determine the Patient's Global Assessment score on fiteBac versus emollient control



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01950494


Locations
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United States, Colorado
National Jewish Health
Denver, Colorado, United States, 80206
Sponsors and Collaborators
National Jewish Health
Investigators
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Principal Investigator: Donald Leung, MD, PhD National Jewish Health

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Responsible Party: Donald Leung, MD, PhD, Principal Investigator, National Jewish Health
ClinicalTrials.gov Identifier: NCT01950494    
Other Study ID Numbers: FiteBacFINAL
Fite Bac Hand Sanitizer ( Other Identifier: FiteBac Hand Sanitizer )
First Posted: September 25, 2013    Key Record Dates
Last Update Posted: January 5, 2017
Last Verified: January 2017
Keywords provided by Donald Leung, MD, PhD, National Jewish Health:
hand dermatitis
health care workers
hand sanitizer
Additional relevant MeSH terms:
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Dermatitis
Skin Diseases
Hand Sanitizers
Emollients
Dermatologic Agents
Anti-Infective Agents, Local
Anti-Infective Agents
Disinfectants