Hand DermatitisFiteBacNCT01950494
FiteBac Hand Sanitizer in the Management of Hand Dermatitis in Adults
A study testing fiteBac Hand Sanitizer in people with Hand Dermatitis, run by National Jewish Health at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Hand Dermatitis
- What is being tested?
- fiteBac Hand Sanitizer
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 22 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2013to Jul 2014
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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).
Who cannot join
- 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
Show all 9Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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
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
- 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
- Conditions
- Hand Dermatitis
- Being tested
- fiteBac Hand Sanitizer
- Keywords
- hand dermatitis, health care workers, hand sanitizer
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
fiteBac Hand SanitizerOther
Also called Brand name: 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.
| Study group | Role | What they receive |
|---|---|---|
| fiteBac Hand Sanitizer | Experimental | Blinded fitBac Hand sanitizer Receives: Other: fiteBac Hand Sanitizer |
| Blinded emollient therapy | Placebo comparator | Blinded emollient therapy Receives: Other: fiteBac Hand Sanitizer |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 1 month
Secondary outcomes (6)
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
Measured: 1 month
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
Measured: 1 month
Adverse events
- Number of adverse events on fiteBac versus emollient control
Measured: 1 month
Number of flares
- To determine the number of flares on fiteBac versus emollient control
Measured: 1 month
Number of study discontinuations
- To determine the number of study discontinuations on fiteBac versus emollient control
Measured: 1 month
Patients Global Assessment score
- To determine the Patient's Global Assessment score on fiteBac versus emollient control
Measured: 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Sep 2013 (estimated)
- Study startSep 2013
- Primary completionJul 2014
- Study completionJul 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hand DermatitisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 22 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Jewish Health
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Donald Leung, MD, PhD, National Jewish Health
- Investigators
- Donald Leung, MD, PhD, Principal investigator, National Jewish Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01950494
- Sponsor's protocol ID
- FiteBacFINAL
- Other IDs
- Fite Bac Hand Sanitizer
- Acronym
- FiteBac
- Status last verified
- Jan 2017
- First submitted
- 23 Sep 2013
- Last updated
- 5 Jan 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Jan 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT01950494
- Acronym / sponsor ID
- FiteBac / FiteBacFINAL
- Conditions
- Hand Dermatitis
- Keywords
- hand dermatitis, health care workers, hand sanitizer
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 22 participants (actual)
- Lead sponsor
- National Jewish HealthUniversity, hospital or other
- Study start
- Sep 2013
- Primary completion
- Jul 2014 (actual)
- Study completion
- Jul 2014 (actual)
- First posted
- 25 Sep 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- 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
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| fiteBac Hand Sanitizer | Experimental | Other: fiteBac Hand SanitizerBlinded fitBac Hand sanitizer |
| Blinded emollient therapy | Placebo comparator | Other: fiteBac Hand SanitizerBlinded emollient therapy |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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).
Key exclusion criteria (9 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| fiteBac Hand SanitizerAlso: Brand name: fiteBac Hand SanitizerSkin 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 | Blinded emollient therapy, fiteBac Hand Sanitizer |
Primary outcome
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.
6 secondary outcomes
Bacterial counts
Time frame: 1 month
Physician Global Assessment
Time frame: 1 month
Adverse events
Time frame: 1 month
Number of flares
Time frame: 1 month
Number of study discontinuations
Time frame: 1 month
Patients Global Assessment score
Time frame: 1 month
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Jan 2017.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Donald Leung, MD, PhD principal investigator
National Jewish Health
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing fiteBac Hand Sanitizer in people with Hand Dermatitis, run by National Jewish Health at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Jan 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Efficacy of fiteBac compared to emollient therapy (time frame: 1 month). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Jan 2017.