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Phase 4 N=31 Randomized Triple-blind Treatment

Pain Outcomes Following Intralesional Corticosteroid Injections

Keloid · Alopecia Areata · Acne · Hypertrophic Scar · Epidermal Inclusion Cyst

Enrolled (actual)
31
Serious AEs
0.0%
Results posted
Mar 2021
Primary outcome: Primary: Pain Outcome: Visual Analog Scale — 5.4; 2.7 Score on a scale

Study Design & Population

Study type
Interventional
Phase
Phase 4
Interventions
Corticosteroid with lidocaine (Drug); Corticosteroid with normal saline (Drug)
Age
Pediatric, Adult, Older Adult · 12+ yrs
Sex
All
Sponsor
Vanderbilt University Medical Center
Primary completion
Sep 2019

Outcome Measures

OutcomeResultp-value
PRIMARY
Pain Outcome: Visual Analog Scale
0.9; 0.1; 0; 0

Summary

Corticosteroid therapy, including intralesional and topical applications, has many indications within the fields of Dermatology, Plastic Surgery, and Orthopedics. However, these injections can be quite painful, which leads many patients to discontinue treatment. Often, the injection involves a mixture of local anesthetic and corticosteroids despite a lack of evidence that the use of lidocaine improves pain. Due to the acidic pH, the lidocaine component of the injection can actually cause a significant burning sensation during the procedure. Lidocaine does not have anti-inflammatory properties and does not treat the underlying pathology. By including another medication, lidocaine also adds cost and risk to the procedure. The purpose of this study is to see if removing lidocaine from intralesional injections decreases the pain of injection.

Eligibility Criteria

Inclusion Criteria

  • >12 years old presenting with an indication for intralesional steroid injection

Exclusion Criteria

  • Unconsentable
  • Not a candidate for corticosteroid injection
  • Contraindication to lidocaine
View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT03630198). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.

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