Trial · NCT01671423
Use of a Single Dose of Oral Prednisone in the Treatment of Cellulitis
NCT01671423, Not applicable, Completed, Albert Einstein Healthcare Network; results first posted 2021-02-10
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Use of a Single Dose of Oral Prednisone in the Treatment of Cellulitis. Trials, record NCT01671423. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01671423
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Use of a Single Dose of Oral Prednisone in the Treatment of Cellulitis
- NCT number
- NCT01671423
- Status
- Completed
- Phases
- Not applicable
- Enrollment
- 42 participants, actual
- Lead sponsor
- Albert Einstein Healthcare Network
- Conditions
- Cellulitis
- Interventions
- Prednisone, Placebo
- First posted
- 2012-08-23
- Last updated
- 2021-02-10
- Results first posted
- 2021-02-10
- Limitations and caveats
- Small sample size
Source ClinicalTrials.gov
Registered outcomes8
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Visual Analog Scale(VAS) for Pain - Day 1 to 48 Hours | Assessed once at day 1 and then once during the 48 hour follow-up | 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. |
| Secondary | Amount of Pain Medication - Day 1 to 48 Hours | Assessed once during the 48 hour follow-up | Number of times the subject needed to use pain medication between day 1 and the 48 hour follow-up |
| Secondary | Amount of Pain Medication - Day 1 to 7 Days | Assessed once during the 7 day follow-up | Total amount of pain medication used between day 1 and the 7 day follow-up call. |
| Secondary | Amount of Pain Medication - 48 Hours to 7 Days | Assessed at the 48 hour follow-up and at the 7 day follow-up | Amount of pain medication the subject needed to use between the 48 hour follow-up and the 7 day follow-up. |
| Secondary | Number of Participants Requiring Additional Medical Assistance Post-Randomization | Assessed continuously from day 1 to the day 7 follow-up call | Need for additional medical intervention to treat the current episode of cellulitis. |
| Secondary | Disposition Trend | Assessed once during day 1 | 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. |
| Secondary | Adverse Events (AE) | Assessed continuously from day 1 to day 7 follow-up | 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) |
| Secondary | Change in Erythema Size - Day 1 to 48 Hours | Calculated once at 48 hrs | 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. |
Source ClinicalTrials.gov
Outcomes8
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Visual Analog Scale(VAS) for Pain - Day 1 to 48 Hours | Assessed once at day 1 and then once during the 48 hour follow-up | score on a scale | MEAN | |
| SECONDARY | Amount of Pain Medication - Day 1 to 48 Hours | Assessed once during the 48 hour follow-up | Data is not available on all participants | medications taken | MEDIAN |
| SECONDARY | Amount of Pain Medication - Day 1 to 7 Days | Assessed once during the 7 day follow-up | Data was not collected | ||
| SECONDARY | Amount of Pain Medication - 48 Hours to 7 Days | Assessed at the 48 hour follow-up and at the 7 day follow-up | Data was not collected | ||
| SECONDARY | Number of Participants Requiring Additional Medical Assistance Post-Randomization | Assessed continuously from day 1 to the day 7 follow-up call | Data was not collected | ||
| SECONDARY | Disposition Trend | Assessed once during day 1 | Data is not available on all participants | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Adverse Events (AE) | Assessed continuously from day 1 to day 7 follow-up | Data not collected on this outcome measure | ||
| SECONDARY | Change in Erythema Size - Day 1 to 48 Hours | Calculated once at 48 hrs | Data not collected on this outcome measure |
Source ClinicalTrials.gov
Results by group10
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Visual Analog Scale(VAS) for Pain - Day 1 to 48 Hours | Prednisone | VAS at Day 1 | 79.64 | Standard Deviation 14.89 | score on a scale |
| Visual Analog Scale(VAS) for Pain - Day 1 to 48 Hours | Placebo | VAS at Day 1 | 56.45 | Standard Deviation 30.25 | score on a scale |
| Visual Analog Scale(VAS) for Pain - Day 1 to 48 Hours | Prednisone | VAS at 48 hrs | 39.71 | Standard Deviation 34.5 | score on a scale |
| Visual Analog Scale(VAS) for Pain - Day 1 to 48 Hours | Placebo | VAS at 48 hrs | 25.91 | Standard Deviation 33.25 | score on a scale |
| Amount of Pain Medication - Day 1 to 48 Hours | Prednisone | 7 | Full Range 0 to 16 | medications taken | |
| Amount of Pain Medication - Day 1 to 48 Hours | Placebo | 2 | Full Range 0 to 12 | medications taken | |
| Disposition Trend | Prednisone | Discharged to Home | 12 | Participants | |
| Disposition Trend | Placebo | Discharged to Home | 8 | Participants | |
| Disposition Trend | Prednisone | Data not available/not collected | 2 | Participants | |
| Disposition Trend | Placebo | Data not available/not collected | 3 | Participants |
Source ClinicalTrials.gov
Participant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Prednisone | 20 | |
| Overall Study | STARTED | Placebo | 20 | |
| Overall Study | COMPLETED | Prednisone | 14 | |
| Overall Study | COMPLETED | Placebo | 9 | |
| Overall Study | NOT COMPLETED | Prednisone | 6 | |
| Overall Study | NOT COMPLETED | Placebo | 11 |
Source ClinicalTrials.gov
Adverse events0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
None in this release.
Adverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Prednisone | 0 | 20 |
| Total, all-cause mortality | Placebo | 0 | 20 |
| Total, other adverse events | Prednisone | 0 | 20 |
| Total, other adverse events | Placebo | 0 | 20 |
| Total, serious adverse events | Prednisone | 0 | 20 |
| Total, serious adverse events | Placebo | 0 | 20 |
Source ClinicalTrials.gov
Papers5
The papers the trial lists on ClinicalTrials.gov.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons2
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Prednisone vs Placebo: deaths from any cause | Trial comparisons |
| Prednisone vs Placebo: serious adverse events | Trial comparisons |
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT01671423
GET https://conductscience.org/api/trials/v1/NCT01671423/registered