Trial Outcomes & Findings for Use of a Single Dose of Oral Prednisone in the Treatment of Cellulitis (NCT NCT01671423)
NCT ID: NCT01671423
Last Updated: 2021-02-10
Results Overview
The level of pain as measured by a Visual Analog Scale(VAS) measured once at day 1 and once during the 48th hour follow-up visit. Minimum value 0, maximum value 100mm, higher scores corresponds to more pain/worse outcomes.
COMPLETED
NA
42 participants
Assessed once at day 1 and then once during the 48 hour follow-up
2021-02-10
Participant Flow
42 participants agreed to participate in the study. Following completion of informed consent process, 1 participant withdrew of their own volition, 1 participant was excluded from analysis for taking NSAID within the first 48 hrs.
Participant milestones
| Measure |
Prednisone
In addition to standard care for cellulitis, subject will receive a single 60 mg dose of Prednisone orally during their initial visit.
Prednisone: See "Prednisone" arm description
|
Placebo
In addition to standard care for cellulitis, subjects will receive a single placebo pill to take during their initial visit.
Placebo: See "Placebo" arm description
|
|---|---|---|
|
Overall Study
STARTED
|
20
|
20
|
|
Overall Study
COMPLETED
|
14
|
9
|
|
Overall Study
NOT COMPLETED
|
6
|
11
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Of the 40 subjects that were randomized, 25 subjects were analyzed; 14 received prednisone, 11 received placebo
Baseline characteristics by cohort
| Measure |
Prednisone
n=14 Participants
In addition to standard care for cellulitis, subject will receive a single 60 mg dose of Prednisone orally during their initial visit.
Prednisone: See "Prednisone" arm description
|
Placebo
n=11 Participants
In addition to standard care for cellulitis, subjects will receive a single placebo pill to take during their initial visit.
Placebo: See "Placebo" arm description
|
Total
n=25 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
40 Years
n=99 Participants • Of the 40 subjects that were randomized, 25 subjects were analyzed; 14 received prednisone, 11 received placebo
|
40 Years
n=107 Participants • Of the 40 subjects that were randomized, 25 subjects were analyzed; 14 received prednisone, 11 received placebo
|
40 Years
n=206 Participants • Of the 40 subjects that were randomized, 25 subjects were analyzed; 14 received prednisone, 11 received placebo
|
|
Sex: Female, Male
Female
|
5 Participants
n=99 Participants • Of the 40 subjects that were randomized, 25 subjects were analyzed; 14 received prednisone, 11 received placebo
|
6 Participants
n=107 Participants • Of the 40 subjects that were randomized, 25 subjects were analyzed; 14 received prednisone, 11 received placebo
|
11 Participants
n=206 Participants • Of the 40 subjects that were randomized, 25 subjects were analyzed; 14 received prednisone, 11 received placebo
|
|
Sex: Female, Male
Male
|
9 Participants
n=99 Participants • Of the 40 subjects that were randomized, 25 subjects were analyzed; 14 received prednisone, 11 received placebo
|
5 Participants
n=107 Participants • Of the 40 subjects that were randomized, 25 subjects were analyzed; 14 received prednisone, 11 received placebo
|
14 Participants
n=206 Participants • Of the 40 subjects that were randomized, 25 subjects were analyzed; 14 received prednisone, 11 received placebo
|
PRIMARY outcome
Timeframe: Assessed once at day 1 and then once during the 48 hour follow-upThe level of pain as measured by a Visual Analog Scale(VAS) measured once at day 1 and once during the 48th hour follow-up visit. Minimum value 0, maximum value 100mm, higher scores corresponds to more pain/worse outcomes.
Outcome measures
| Measure |
Prednisone
n=14 Participants
In addition to standard care for cellulitis, subject will receive a single 60 mg dose of Prednisone orally during their initial visit.
Prednisone: See "Prednisone" arm description
|
Placebo
n=11 Participants
In addition to standard care for cellulitis, subjects will receive a single placebo pill to take during their initial visit.
Placebo: See "Placebo" arm description
|
|---|---|---|
|
Visual Analog Scale(VAS) for Pain - Day 1 to 48 Hours
VAS at Day 1
|
79.64 score on a scale
Standard Deviation 14.89
|
56.45 score on a scale
Standard Deviation 30.25
|
|
Visual Analog Scale(VAS) for Pain - Day 1 to 48 Hours
VAS at 48 hrs
|
39.71 score on a scale
Standard Deviation 34.5
|
25.91 score on a scale
Standard Deviation 33.25
|
SECONDARY outcome
Timeframe: Assessed once during the 48 hour follow-upPopulation: Data is not available on all participants
Number of times the subject needed to use pain medication between day 1 and the 48 hour follow-up
Outcome measures
| Measure |
Prednisone
n=14 Participants
In addition to standard care for cellulitis, subject will receive a single 60 mg dose of Prednisone orally during their initial visit.
Prednisone: See "Prednisone" arm description
|
Placebo
n=11 Participants
In addition to standard care for cellulitis, subjects will receive a single placebo pill to take during their initial visit.
Placebo: See "Placebo" arm description
|
|---|---|---|
|
Amount of Pain Medication - Day 1 to 48 Hours
|
7 medications taken
Interval 0.0 to 16.0
|
2 medications taken
Interval 0.0 to 12.0
|
SECONDARY outcome
Timeframe: Assessed once during the 7 day follow-upPopulation: Data was not collected
Total amount of pain medication used between day 1 and the 7 day follow-up call.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Assessed at the 48 hour follow-up and at the 7 day follow-upPopulation: Data was not collected
Amount of pain medication the subject needed to use between the 48 hour follow-up and the 7 day follow-up.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Assessed continuously from day 1 to the day 7 follow-up callPopulation: Data was not collected
Need for additional medical intervention to treat the current episode of cellulitis.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Assessed once during day 1Population: Data is not available on all participants
Disposition of the subject at the end of the initial visit on day 1; "Disposition Trend" refers to whether the subject was discharged to home or admitted to observation unit in the hospital. This Outcome Measure intends to assess improvement from baseline following intervention.
Outcome measures
| Measure |
Prednisone
n=14 Participants
In addition to standard care for cellulitis, subject will receive a single 60 mg dose of Prednisone orally during their initial visit.
Prednisone: See "Prednisone" arm description
|
Placebo
n=11 Participants
In addition to standard care for cellulitis, subjects will receive a single placebo pill to take during their initial visit.
Placebo: See "Placebo" arm description
|
|---|---|---|
|
Disposition Trend
Discharged to Home
|
12 Participants
|
8 Participants
|
|
Disposition Trend
Data not available/not collected
|
2 Participants
|
3 Participants
|
SECONDARY outcome
Timeframe: Assessed continuously from day 1 to day 7 follow-upPopulation: Data not collected on this outcome measure
Development of adverse events during study period such as: allergic reaction, development of severe sepsis or septic shock, crepitus, change in mentation, fever greater than or equal to 39 degrees Celsius, tachycardia (heart rate over 120 beats per minute)
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Calculated once at 48 hrsPopulation: Data not collected on this outcome measure
Change in erythema size - day 1 to 48 hours = (Mean erythema at Day 1) - (Mean erythema at 48 hrs) Erythema is measured in millimeters using the most proximal and distal area of the erythema. Higher values represent worse outcome.
Outcome measures
Outcome data not reported
Adverse Events
Prednisone
Placebo
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place