Trial Outcomes & Findings for Treatment of Staphylococcus Aureus Colonization in Hand Eczema (NCT NCT01591785)
NCT ID: NCT01591785
Last Updated: 2020-12-03
Results Overview
Physician's Global Assessment PGA 0 = Clear (no inflammatory signs of atopic dermatitis) 1 = Almost clear (just perceptible erythema and papulation/infiltration)
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
60 participants
Primary outcome timeframe
Day 15
Results posted on
2020-12-03
Participant Flow
The study was conducted from January 2012 to August 2012, all subjects were enrolled at one site.
Participant milestones
| Measure |
Retapamulin 1% Ointment
twice daily topical application of clobetasol propionate foam 0.05% for 14 days and Retapamulin 1% ointment for 5 days
|
Placebo Ointment
twice daily topical application of clobetasol propionate foam 0.05% for 14 days and placebo ointment for 5 days
|
|---|---|---|
|
Overall Study
STARTED
|
30
|
30
|
|
Overall Study
COMPLETED
|
26
|
28
|
|
Overall Study
NOT COMPLETED
|
4
|
2
|
Reasons for withdrawal
| Measure |
Retapamulin 1% Ointment
twice daily topical application of clobetasol propionate foam 0.05% for 14 days and Retapamulin 1% ointment for 5 days
|
Placebo Ointment
twice daily topical application of clobetasol propionate foam 0.05% for 14 days and placebo ointment for 5 days
|
|---|---|---|
|
Overall Study
worsening condition
|
1
|
2
|
|
Overall Study
Protocol Violation
|
2
|
0
|
|
Overall Study
Lost to Follow-up
|
1
|
0
|
Baseline Characteristics
Treatment of Staphylococcus Aureus Colonization in Hand Eczema
Baseline characteristics by cohort
| Measure |
Retapamulin 1% Ointment
n=30 Participants
twice daily topical application of clobetasol propionate foam 0.05% for 14 days and Retapamulin 1% ointment for 5 days
|
Placebo Ointment
n=30 Participants
twice daily topical application of clobetasol propionate foam 0.05% for 14 days and placebo ointment for 5 days
|
Total
n=60 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
41.5 years
n=5 Participants
|
44.4 years
n=7 Participants
|
43 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
17 Participants
n=5 Participants
|
20 Participants
n=7 Participants
|
37 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
13 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
23 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
6 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
16 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
24 Participants
n=5 Participants
|
20 Participants
n=7 Participants
|
44 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
2 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
11 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
17 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
17 Participants
n=5 Participants
|
23 Participants
n=7 Participants
|
40 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Physician Global Assessment (PGA)
|
3.5 units on a scale
n=5 Participants
|
3.7 units on a scale
n=7 Participants
|
3.6 units on a scale
n=5 Participants
|
PRIMARY outcome
Timeframe: Day 15Physician's Global Assessment PGA 0 = Clear (no inflammatory signs of atopic dermatitis) 1 = Almost clear (just perceptible erythema and papulation/infiltration)
Outcome measures
| Measure |
Retapamulin 1% Ointment
n=30 Participants
twice daily topical application of clobetasol propionate foam 0.05% for 14 days and Retapamulin 1% ointment for 5 days
|
Placebo Ointment
n=30 Participants
twice daily topical application of clobetasol propionate foam 0.05% for 14 days and placebo ointment for 5 days
|
|---|---|---|
|
Number of Participants With PGA of 0 or 1
|
22 participants
|
14 participants
|
PRIMARY outcome
Timeframe: Day 28Physician's Global Assessment PGA 0 = Clear (no inflammatory signs of atopic dermatitis) 1 = Almost clear (just perceptible erythema and papulation/infiltration)
Outcome measures
| Measure |
Retapamulin 1% Ointment
n=30 Participants
twice daily topical application of clobetasol propionate foam 0.05% for 14 days and Retapamulin 1% ointment for 5 days
|
Placebo Ointment
n=30 Participants
twice daily topical application of clobetasol propionate foam 0.05% for 14 days and placebo ointment for 5 days
|
|---|---|---|
|
Number of Participants With PGA of 0 or 1
|
15 participants
|
11 participants
|
SECONDARY outcome
Timeframe: Day 15The 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
Outcome measures
| Measure |
Retapamulin 1% Ointment
n=30 Participants
twice daily topical application of clobetasol propionate foam 0.05% for 14 days and Retapamulin 1% ointment for 5 days
|
Placebo Ointment
n=30 Participants
twice daily topical application of clobetasol propionate foam 0.05% for 14 days and placebo ointment for 5 days
|
|---|---|---|
|
Staph Aureus Culture Results
|
61 percentage of participants
|
30 percentage of participants
|
SECONDARY outcome
Timeframe: Day 28The 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
Outcome measures
| Measure |
Retapamulin 1% Ointment
n=30 Participants
twice daily topical application of clobetasol propionate foam 0.05% for 14 days and Retapamulin 1% ointment for 5 days
|
Placebo Ointment
n=30 Participants
twice daily topical application of clobetasol propionate foam 0.05% for 14 days and placebo ointment for 5 days
|
|---|---|---|
|
Staph Aureus Culture Results
|
28 percentage of participants
|
13 percentage of participants
|
Adverse Events
Retapamulin 1% Ointment
Serious events: 0 serious events
Other events: 5 other events
Deaths: 0 deaths
Placebo Ointment
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Retapamulin 1% Ointment
n=30 participants at risk
twice daily topical application of clobetasol propionate foam 0.05% for 14 days and Retapamulin 1% ointment for 5 days
|
Placebo Ointment
n=30 participants at risk
twice daily topical application of clobetasol propionate foam 0.05% for 14 days and placebo ointment for 5 days
|
|---|---|---|
|
Renal and urinary disorders
Urinary Tract Infection
|
3.3%
1/30 • 8 months
|
0.00%
0/30 • 8 months
|
|
Respiratory, thoracic and mediastinal disorders
Upper respiratory infection
|
6.7%
2/30 • 8 months
|
3.3%
1/30 • 8 months
|
|
Skin and subcutaneous tissue disorders
Eczema flare
|
3.3%
1/30 • 8 months
|
3.3%
1/30 • 8 months
|
|
Skin and subcutaneous tissue disorders
Dryness
|
0.00%
0/30 • 8 months
|
3.3%
1/30 • 8 months
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
3.3%
1/30 • 8 months
|
0.00%
0/30 • 8 months
|
Additional Information
Gary Goldenberg, MD
Icahn School of Medicine at Mount Sinai
Phone: 212-241-6500
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place