NCT01950494

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
22

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Sep 2013

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2013

Completed
22 days until next milestone

First Submitted

Initial submission to the registry

September 23, 2013

Completed
2 days until next milestone

First Posted

Study publicly available on registry

September 25, 2013

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2014

Completed
Last Updated

January 5, 2017

Status Verified

January 1, 2017

Enrollment Period

10 months

First QC Date

September 23, 2013

Last Update Submit

January 3, 2017

Conditions

Hand Dermatitis

Keywords

hand dermatitishealth care workershand sanitizer

Outcome Measures

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.

    1 month

Secondary Outcomes (6)

  • Bacterial counts

    1 month

  • Physician Global Assessment

    1 month

  • Adverse events

    1 month

  • Number of flares

    1 month

  • Number of study discontinuations

    1 month

  • +1 more secondary outcomes

Study Arms (2)

fiteBac Hand Sanitizer

EXPERIMENTAL

Blinded fitBac Hand sanitizer

Other: fiteBac Hand Sanitizer

Blinded emollient therapy

PLACEBO COMPARATOR

Blinded emollient therapy

Other: fiteBac Hand Sanitizer

Interventions

fiteBac Hand SanitizerOTHER

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
Blinded emollient therapyfiteBac Hand Sanitizer

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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).

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

National Jewish Health

Denver, Colorado, 80206, United States

Location

Study Officials

  • Donald Leung, MD, PhD

    National Jewish Health

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

September 23, 2013

First Posted

September 25, 2013

Study Start

September 1, 2013

Primary Completion

July 1, 2014

Study Completion

July 1, 2014

Last Updated

January 5, 2017

Record last verified: 2017-01

Locations

US(1)