Treatment of Staphylococcus Aureus Colonization in Hand Eczema

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Gary Goldenberg, Mount Sinai School of Medicine
ClinicalTrials.gov Identifier:
NCT01591785
First received: April 30, 2012
Last updated: May 2, 2013
Last verified: May 2013
  Purpose

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.


Condition Intervention
Hand Eczema
Foot Eczema
Drug: Retapamulin 1% ointment
Drug: Placebo

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: An Investigator-Initiated Study: Treatment of Staphylococcus Aureus Colonization in Hand Eczema Decreases Severity of Disease

Resource links provided by NLM:


Further study details as provided by Mount Sinai School of Medicine:

Primary Outcome Measures:
  • Physician Assessments [ Time Frame: Day 6 ] [ Designated as safety issue: No ]
    PGA (physician's global assessement) and TLSS (target lesion symptom score)

  • Physician Assessments [ Time Frame: Day 15 ] [ Designated as safety issue: No ]
    PGA (physician's global assessement) and TLSS (target lesion symptom score)

  • Physician Assessments [ Time Frame: Day 28 ] [ Designated as safety issue: No ]
    PGA (physician's global assessement) and TLSS (target lesion symptom score)


Secondary Outcome Measures:
  • Staph Aureus culture results [ Time Frame: Day 15 ] [ Designated as safety issue: No ]
    Mean change in S aureus intranasal and hand/foot cultures in subjects who test positive for S aureus at Baseline as compared to Visit 3 (Day 15) and Visit 4 (Day 28).

  • Staph Aureus culture results [ Time Frame: Day 28 ] [ Designated as safety issue: No ]
    Mean change in S aureus intranasal and hand/foot cultures in subjects who test positive for S aureus at Baseline as compared to Visit 3 (Day 15) and Visit 4 (Day 28).


Enrollment: 60
Study Start Date: January 2012
Study Completion Date: August 2012
Primary Completion Date: August 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 Name: 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 Name: Petroleum jelly

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01591785

Locations
United States, New York
Mount Sinai School of Medicine
New York, New York, United States, 10029
Sponsors and Collaborators
Gary Goldenberg
Investigators
Principal Investigator: Gary Goldenberg, MD Mount Sinai School of Medicine
  More Information

Publications:

Responsible Party: Gary Goldenberg, Principal Investigator, Mount Sinai School of Medicine
ClinicalTrials.gov Identifier: NCT01591785     History of Changes
Other Study ID Numbers: GCO 11-0038
Study First Received: April 30, 2012
Last Updated: May 2, 2013
Health Authority: United States: Food and Drug Administration

Keywords provided by Mount Sinai School of Medicine:
Hand
Foot
Eczema
Atopic Dermatitis

Additional relevant MeSH terms:
Eczema
Dermatitis
Skin Diseases
Skin Diseases, Eczematous
Clobetasol
Anti-Inflammatory Agents
Therapeutic Uses
Pharmacologic Actions
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on September 30, 2014