Treatment of Staphylococcus Aureus Colonization in Hand Eczema

December 2, 2020 updated by: Gary Goldenberg

An Investigator-Initiated Study: Treatment of Staphylococcus Aureus Colonization in Hand Eczema Decreases Severity of Disease

Atopic dermatitis is a chronic disease characterized by itching and eczematous lesions. In adults, eczema commonly localizes to the hands or feet. Several studies have implicated bacterial contamination, especially with Staphylococcus aureus (S. aureus), to be a factor in atopic dermatitis, as infection with this bacteria correlates with disease severity. No trial to date has investigated how to treat S. aureus infection in adults with hand or hand/foot dermatitis. Using retapamulin ointment in the nose and on the hands or hands/feet, the investigators expect to have a significant clearance rate of s. aureus infection. The investigators believe that treating the bacterial infection along with treating the condition with a topical corticosteroid will significantly decrease the severity of hand/foot dermatitis in our study population.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Primary Study Objectives:

  1. To evaluate the efficacy of retapamulin 1% ointment with clobetasol propionate 0.05% foam versus vehicle ointment with clobetasol propionate 0.05% foam as a treatment regimen for hand or hand/foot atopic dermatitis.
  2. To evaluate the incidence of intranasal and hand/foot S aureus carriage rates in subjects with hand/foot atopic dermatitis via cultures of an anterior nare and the most severely graded target lesion of the hand/foot dermatitis.
  3. To evaluate the incidence of mupirocin-resistance and methicillin-resistance in S aureus isolates in subjects with hand/foot atopic dermatitis via cultures of an anterior nare and the most severely graded target lesion of the hand/foot dermatitis.

Primary and secondary endpoints will be analyzed by appropriate statistical models by a qualified statistician. Any results of this pilot study will be treated as exploratory and hypothesis generating.

Study Type

Interventional

Enrollment (Actual)

60

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • New York
      • New York, New York, United States, 10029
        • Mount Sinai School of Medicine

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Male or female subjects at least 18 years of age with a clear diagnosis of moderate-to-severe hand or hand/foot dermatitis.
  • Subjects must be in general good health as confirmed by a medical history.
  • Subjects must be capable of understanding and willing to provide a signed and dated written voluntary informed consent before any protocol specific procedures are performed.
  • At the Baseline Visit, Subjects must have a Physician's Global Assessment (PGA) of at least 3 (moderate severity).
  • Subject must be willing and able to participate in the study as an outpatient, making frequent visits to the study center during the treatment and follow-up period periods and comply with all study requirements.
  • If a subject is a female of childbearing potential she must have a negative urine pregnancy test prior to study treatment initiation and must agree to use an approved method of birth control during the study period (barrier, oral, injection, intrauterine). NOTE: Post-menopausal (amenorrhea for at least one year) or surgically sterile (tubal ligation and/or hysterectomy) females are categorized as non-childbearing potential.

Exclusion Criteria:

  • Non-English speaking subjects
  • Females who are pregnant, breast feeding, or attempting to conceive.
  • Subjects with a history of known or suspected intolerance to any of the excipients of retapamulin 1% ointment or clobetasol propionate 0.05% foam.
  • Subjects who have used any topical corticosteroids, topical antibiotics, topical immunosuppressants, other topical therapies (tar, calcineurin inhibitors), or phototherapy (PUVA, UVB) within eight weeks of the Baseline Visit.
  • Subjects who have used any systemic corticosteroids, systemic antibiotics, or systemic immunosuppressants therapies within eight weeks of the Baseline Visit.
  • Subjects with any overt signs of skin atrophy, telangiectasias, and/or striae in the target area(s).
  • Subjects with any active skin malignancy.
  • Subjects requiring the use of medications known to alter the course of atopic dermatitis during the study period.
  • Subjects who are currently participating in or, within the previous 28 days, have participated in another study for the treatment for atopic dermatitis.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: DOUBLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
ACTIVE_COMPARATOR: Retapamulin 1% ointment
Retapamulin 1% ointment for 5 days AND clobetasol propionate foam for 14 days
Drug: Retapamulin 1% ointment
Retapamulin 1% ointment for 5 days AND clobetasol propionate foam for 14 days
Other Names:
  • Altabax and Olux Foam
PLACEBO_COMPARATOR: Placebo ointment
Placebo ointment for 5 days AND clobetasol propionate foam for 14 days
Drug: Placebo
Placebo ointment for 5 days AND clobetasol propionate foam for 14 days
Other Names:
  • Petroleum jelly

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of Participants With PGA of 0 or 1
Time Frame: Day 15

Physician's Global Assessment PGA 0 = Clear (no inflammatory signs of atopic dermatitis)

1 = Almost clear (just perceptible erythema and papulation/infiltration)
Day 15
Number of Participants With PGA of 0 or 1
Time Frame: Day 28

Physician's Global Assessment PGA 0 = Clear (no inflammatory signs of atopic dermatitis)

1 = Almost clear (just perceptible erythema and papulation/infiltration)
Day 28

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Staph Aureus Culture Results
Time Frame: Day 15
The percentage of subjects who had both negative S. aureus skin and nares cultures with a PGA of clear/almost clear at day 15 compared to baseline
Day 15
Staph Aureus Culture Results
Time Frame: Day 28
The percentage of subjects who had both negative S. aureus skin and nares cultures with a PGA of clear/almost clear at day 28 compared to baseline
Day 28

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Gary Goldenberg

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2012

Primary Completion (ACTUAL)

August 1, 2012

Study Completion (ACTUAL)

August 1, 2012

Study Registration Dates

First Submitted

April 30, 2012

First Submitted That Met QC Criteria

May 2, 2012

First Posted (ESTIMATE)

May 4, 2012

Study Record Updates

Last Update Posted (ACTUAL)

December 3, 2020

Last Update Submitted That Met QC Criteria

December 2, 2020

Last Verified

December 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • GCO 11-0038

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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