Foot Eczema, Hand Eczema
Conditions
Keywords
Hand, Foot, Eczema, Atopic Dermatitis
Brief summary
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.
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.
Interventions
Retapamulin 1% ointment for 5 days AND clobetasol propionate foam for 14 days
DRUGPlacebo
Placebo ointment for 5 days AND clobetasol propionate foam for 14 days
Sponsors
Gary Goldenberg
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With PGA of 0 or 1 | Day 15 | Physician's Global Assessment PGA 0 = Clear (no inflammatory signs of atopic dermatitis) 1 = Almost clear (just perceptible erythema and papulation/infiltration) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Staph Aureus Culture Results | 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 |
Countries
United States
Participant flow
Recruitment details
The study was conducted from January 2012 to August 2012, all subjects were enrolled at one site.
Participants by arm
| Arm | Count |
|---|---|
| Retapamulin 1% Ointment twice daily topical application of clobetasol propionate foam 0.05% for 14 days and Retapamulin 1% ointment for 5 days | 30 |
| Placebo Ointment twice daily topical application of clobetasol propionate foam 0.05% for 14 days and placebo ointment for 5 days | 30 |
| Total | 60 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Lost to Follow-up | 1 | 0 |
| Overall Study | Protocol Violation | 2 | 0 |
| Overall Study | worsening condition | 1 | 2 |
Baseline characteristics
| Characteristic | Retapamulin 1% Ointment | Placebo Ointment | Total |
|---|---|---|---|
| Age, Continuous | 41.5 years | 44.4 years | 43 years |
| Ethnicity (NIH/OMB) Hispanic or Latino | 6 Participants | 10 Participants | 16 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 24 Participants | 20 Participants | 44 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Physician Global Assessment (PGA) | 3.5 units on a scale | 3.7 units on a scale | 3.6 units on a scale |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 2 Participants | 1 Participants | 3 Participants |
| Race (NIH/OMB) Black or African American | 11 Participants | 6 Participants | 17 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 17 Participants | 23 Participants | 40 Participants |
| Sex: Female, Male Female | 17 Participants | 20 Participants | 37 Participants |
| Sex: Female, Male Male | 13 Participants | 10 Participants | 23 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 30 | 0 / 30 |
| other Total, other adverse events | 5 / 30 | 3 / 30 |
| serious Total, serious adverse events | 0 / 30 | 0 / 30 |
Outcome results
Primary
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
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Retapamulin 1% Ointment | Number of Participants With PGA of 0 or 1 | 22 participants |
| Placebo Ointment | Number of Participants With PGA of 0 or 1 | 14 participants |
p-value: 0.035Chi-squared
Primary
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
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Retapamulin 1% Ointment | Number of Participants With PGA of 0 or 1 | 15 participants |
| Placebo Ointment | Number of Participants With PGA of 0 or 1 | 11 participants |
p-value: 0.28Chi-squared
Secondary
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
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Retapamulin 1% Ointment | Staph Aureus Culture Results | 61 percentage of participants |
| Placebo Ointment | Staph Aureus Culture Results | 30 percentage of participants |
p-value: 0.0495Chi-squared
Secondary
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
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Retapamulin 1% Ointment | Staph Aureus Culture Results | 28 percentage of participants |
| Placebo Ointment | Staph Aureus Culture Results | 13 percentage of participants |
p-value: 0.27Chi-squared