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.
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
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
60
Retapamulin 1% ointment for 5 days AND clobetasol propionate foam for 14 days
Placebo ointment for 5 days AND clobetasol propionate foam for 14 days
Mount Sinai School of Medicine
New York, New York, United States
Number of Participants With PGA of 0 or 1
Physician's Global Assessment PGA 0 = Clear (no inflammatory signs of atopic dermatitis) 1 = Almost clear (just perceptible erythema and papulation/infiltration)
Time frame: Day 15
Number of Participants With PGA of 0 or 1
Physician's Global Assessment PGA 0 = Clear (no inflammatory signs of atopic dermatitis) 1 = Almost clear (just perceptible erythema and papulation/infiltration)
Time frame: Day 28
Staph Aureus Culture Results
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
Time frame: Day 15
Staph Aureus Culture Results
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
Time frame: Day 28
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