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WithdrawnNCT00893048Updated Jul 25, 2017

The Use of Oral Steroids in the Treatment of Cellulitis

A Phase 2 interventional study of Prednisone and Placebo Oral Tablet in Cellulitis and Erysipelas, sponsored by Milton S. Hershey Medical Center. Withdrawn. Open to participants aged 18 Years to 70 Years. Per ClinicalTrials.gov, last updated 2017-07-25.

Sponsored by Milton S. Hershey Medical Center · Phase 2, Interventional, and Treatment

Why this study was withdrawn
Study never enrolled any subjects before auto-terminated by the internal IRB.
Phase
Phase 2
Study type
Interventional
Enrollment
0
Allocation
Randomized
Ages
18 Years to 70 Years
Sex
All
01

Study summary

The prevalence of cellulitis in society is very high, as much as 3% of visits to Emergency Departments are for the treatment of this disease. The treatment of cellulitis varies depending on the severity. Low severity cases are treated with pain control and antibiotics by mouth and high severity are treated with antibiotics intravenously and pain control. The investigator's hypothesis is to see if the addition of steroids, which are known to decrease inflammation, will decrease the length of the disease process. If so, it will decrease the length of stay if IV antibiotics are needed, it will decrease duration of days out of work and decrease the overall pain control required and therefore patient satisfaction.

Read the detailed description

The incidence of cellulitis is about 24.6 cases per 1000 person-years, which is an estimate, since cellulitis is not a reportable disease. In some Emergency Departments up to 3% of visits are for cellulitis. Depending on the severity of the disease, some are treated as outpatients, and others are admitted for IV antibiotics. In some Emergency Departments cases of cellulitis are treated in an observation area for 23 hours with doses of IV antibiotics. My proposed research is to see if the addition of one dose of prednisone the treatment will decrease the inflammatory reaction enough to decrease length of stay and treatment and increase patient satisfaction.

02

Conditions studied

  • Cellulitis
  • Erysipelas

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Keywords

  • prednisone
  • cellulitis
  • erysipelas
  • steroids
  • oral
03

In context

Cellulitis

147 studies on the registry are indexed under Cellulitis; 14 are open to participants now.

Browse Cellulitis studies →

Lead sponsor

Milton S. Hershey Medical Center is the lead sponsor of 480 studies on the registry; 61 are open to participants now.

Of its 56 completed or terminated interventional studies of FDA-regulated products, 42 (75%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 70 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • 18-70 years old
  • signs/symptoms of cellulitis

Exclusion criteria

Exclusion Criteria:

  • steroid use in last 2 weeks
  • hx of adrenal insufficiency
  • suspicion for dvt or abcess
  • systemic signs of sepsis
  • ICU admission
05

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Outcomes assessor)
Enrollment
0 participants (actual)

Study arms

  • Experimental
    Prednisone

    Use of prednisone to decrease LOS and overall treatment time of cellulitis

    Drug: Prednisone

  • Experimental
    Placebo

    Drug: Placebo Oral Tablet

Interventions

  • DrugPrednisone

    Prednisone, 60 mg, one time at time of diagnosis

    Also known as: sterapred, sterapred DS

  • DrugPlacebo Oral Tablet

    Placebo

06

What researchers measure

Primary outcomes

  1. Time to cellulitis resolving

    Time frame: 48 hours after initiation of treatment

Secondary outcomes

  1. Length of stay

    Time frame: after treatment completed

07

Study locations

No study locations are listed for this record.

08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 25, 2017, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT00893048
Lead sponsor
Milton S. Hershey Medical Center
Responsible party
Sponsor
First posted
May 5, 2009
Start date
Jan 15, 2010
Primary completion
Aug 31, 2010
Completion
Aug 31, 2010
Last update
Jul 25, 2017

Study contacts

Scott Goldstein, DO
principal investigator · Penn State

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is withdrawn, as verified in Jul 2017. You cannot join it, but the record below documents what was studied.

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