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

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.

Study Overview

• Status: Completed
• Conditions: Hand Dermatitis
• Intervention / Treatment: Other: fiteBac Hand Sanitizer

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

• Study Type: Interventional
• Enrollment (Actual): 22
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Colorado
    • Denver, Colorado, United States, 80206
      • National Jewish Health

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / 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 Names: Brand name: fiteBac Hand Sanitizer
Placebo Comparator: 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 Names: Brand name: fiteBac Hand Sanitizer

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	1 month

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	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	1 month
Adverse events	- Number of adverse events on fiteBac versus emollient control	1 month
Number of flares	- To determine the number of flares on fiteBac versus emollient control	1 month
Number of study discontinuations	- To determine the number of study discontinuations on fiteBac versus emollient control	1 month
Patients Global Assessment score	- To determine the Patient's Global Assessment score on fiteBac versus emollient control	1 month

Collaborators and Investigators

• Sponsor: National Jewish Health

Study record dates

Study Major Dates

• Study Start: September 1, 2013
• Primary Completion (Actual): July 1, 2014
• Study Completion (Actual): July 1, 2014

Study Registration Dates

• First Submitted: September 23, 2013
• First Submitted That Met QC Criteria: September 23, 2013
• First Posted (Estimate): September 25, 2013

Study Record Updates

• Last Update Posted (Estimate): January 5, 2017
• Last Update Submitted That Met QC Criteria: January 3, 2017
• Last Verified: January 1, 2017

More Information

Terms related to this study

• Keywords: hand sanitizer; hand dermatitis; health care workers
• Additional Relevant MeSH Terms: Skin Diseases; Dermatitis; Anti-Infective Agents, Local; Anti-Infective Agents; Disinfectants; Hand Sanitizers
• Other Study ID Numbers: FiteBacFINAL; Fite Bac Hand Sanitizer (Other Identifier: FiteBac Hand Sanitizer)