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CompletedNCT01950494FiteBacUpdated Jan 5, 2017

FiteBac Hand Sanitizer in the Management of Hand Dermatitis in Adults

An interventional study of fiteBac Hand Sanitizer in Hand Dermatitis, sponsored by National Jewish Health. Completed at 1 site in United States. Open to participants aged 18 Years to 70 Years. Per ClinicalTrials.gov, last updated 2017-01-05.

Sponsored by National Jewish Health · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
22
Allocation
Randomized
Ages
18 Years to 70 Years
Sex
All
01

Study 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.

Read the 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
02

Conditions studied

  • Hand Dermatitis

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Keywords

  • hand dermatitis
  • health care workers
  • hand sanitizer
03

In context

Dermatitis

1,435 studies on the registry are indexed under Dermatitis; 131 are open to participants now.

This study's enrollment of 22 is below the median of 64 across 1,131 interventional studies indexed under Dermatitis.

Browse Dermatitis studies →

Lead sponsor

National Jewish Health is the lead sponsor of 108 studies on the registry; 14 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 70 Years
Sexes eligible
All
Accepts healthy volunteers
No

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

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
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
22 participants (actual)

Study arms

  • Experimental
    fiteBac Hand Sanitizer

    Blinded fitBac Hand sanitizer

    Other: fiteBac Hand Sanitizer

  • Placebo comparator
    Blinded emollient therapy

    Blinded emollient therapy

    Other: fiteBac Hand Sanitizer

Interventions

  • OtherfiteBac 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.

    Also known as: Brand name: fiteBac Hand Sanitizer

06

What researchers measure

Primary outcomes

  1. Efficacy of fiteBac compared to emollient therapy

    - 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.

    Time frame: 1 month

Secondary outcomes

  1. Bacterial counts

    - To compare the bacterial counts on the hands of patients with hand dermatitis treated with one month of fiteBac skin care versus emollient therapy

    Time frame: 1 month

  2. Physician Global Assessment

    - To determine the Physician Global Assessment (PGA) of overall hand dermatitis severity with excellent response defined as clear or almost clear hands

    Time frame: 1 month

  3. Adverse events

    - Number of adverse events on fiteBac versus emollient control

    Time frame: 1 month

  4. Number of flares

    - To determine the number of flares on fiteBac versus emollient control

    Time frame: 1 month

  5. Number of study discontinuations

    - To determine the number of study discontinuations on fiteBac versus emollient control

    Time frame: 1 month

  6. Patients Global Assessment score

    - To determine the Patient's Global Assessment score on fiteBac versus emollient control

    Time frame: 1 month

07

Study locations

1 site
  • National Jewish Health
    Denver, Colorado 80206, United States
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jan 5, 2017, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT01950494
Lead sponsor
National Jewish Health
Responsible party
Donald Leung, MD, PhD (Principal Investigator, National Jewish Health) — Principal investigator
First posted
Sep 25, 2013
Start date
Sep 2013
Primary completion
Jul 2014
Completion
Jul 2014
Last update
Jan 5, 2017

Study contacts

Donald Leung, MD, PhD
principal investigator · National Jewish Health

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jan 2017. You cannot join it, but the record below documents what was studied.

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