Treatment of Staphylococcus Aureus Colonization in Hand Eczema
| Status: | Completed |
|---|---|
| Conditions: | Skin and Soft Tissue Infections, Dermatology |
| Therapuetic Areas: | Dermatology / Plastic Surgery |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 10/14/2017 |
| Start Date: | January 2012 |
| End Date: | August 2012 |
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.
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.
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.
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.
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.
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