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Pain Outcomes Following Intralesional Corticosteroid Injections

NCT03630198 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 31

Last updated 2021-03-11

Study results available
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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.

Conditions

  • Keloid
  • Alopecia Areata
  • Acne
  • Hypertrophic Scar
  • Epidermal Inclusion Cyst
  • Frontal Fibrosing Alopecia
  • Lichen Plano-Pilaris
  • Keratoacanthoma
  • Plaque Psoriasis
  • Lichen Simplex Chronicus
  • Prurigo Nodularis
  • Nummular Eczema
  • Granuloma Annulare
  • Morphea
  • Lichen Planus

Interventions

DRUG

Corticosteroid with lidocaine

Intralesional corticosteroid injection

DRUG

Corticosteroid with normal saline

Intralesional corticosteroid injection

Sponsors & Collaborators

  • Vanderbilt University Medical Center

    lead OTHER

Principal Investigators

  • Brian Drolet, MD · Vanderbilt University Medical Center

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
12 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2018-10-01
Primary Completion
2019-09-01
Completion
2019-09-01
FDA Drug
Yes

Countries

  • United States

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03630198 on ClinicalTrials.gov