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Pain Outcomes Following Intralesional Corticosteroid Injections

Primary Purpose

Keloid, Alopecia Areata, Acne

Status
Completed
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Corticosteroid with lidocaine
Corticosteroid with normal saline
Sponsored by
Vanderbilt University Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Keloid focused on measuring corticosteroid, local anesthetic

Eligibility Criteria

12 Years - undefined (Child, Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Vanderbilt University Medical Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Corticosteroid with lidocaine

Corticosteroid with normal saline

Arm Description

This arm will include an injection mixture of corticosteroid and lidocaine

This arm will include a mixture of corticosteroid and normal saline. The purpose of normal saline is to keep the volume and concentration similar when compared to the injections containing lidocaine.

Outcomes

Primary Outcome Measures

Pain Outcome: Visual Analog Scale
Assessed using the visual analog scale (0-10 scale). Zero indicates no pain, 10 indicates worst pain ever.

Secondary Outcome Measures

Full Information

First Posted
August 9, 2018
Last Updated
February 18, 2021
Sponsor
Vanderbilt University Medical Center
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1. Study Identification

Unique Protocol Identification Number
NCT03630198
Brief Title
Pain Outcomes Following Intralesional Corticosteroid Injections
Official Title
The Use of Local Anesthetic in Intralesional Corticosteroid Injections; A Randomized, Double Blind Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
February 2021
Overall Recruitment Status
Completed
Study Start Date
October 1, 2018 (Actual)
Primary Completion Date
September 1, 2019 (Actual)
Study Completion Date
September 1, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Vanderbilt University Medical Center

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
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
Keywords
corticosteroid, local anesthetic

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderOutcomes Assessor
Allocation
Randomized
Enrollment
31 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Corticosteroid with lidocaine
Arm Type
Active Comparator
Arm Description
This arm will include an injection mixture of corticosteroid and lidocaine
Arm Title
Corticosteroid with normal saline
Arm Type
Experimental
Arm Description
This arm will include a mixture of corticosteroid and normal saline. The purpose of normal saline is to keep the volume and concentration similar when compared to the injections containing lidocaine.
Intervention Type
Drug
Intervention Name(s)
Corticosteroid with lidocaine
Intervention Description
Intralesional corticosteroid injection
Intervention Type
Drug
Intervention Name(s)
Corticosteroid with normal saline
Intervention Description
Intralesional corticosteroid injection
Primary Outcome Measure Information:
Title
Pain Outcome: Visual Analog Scale
Description
Assessed using the visual analog scale (0-10 scale). Zero indicates no pain, 10 indicates worst pain ever.
Time Frame
Assessed 1 minute after the injection (in clinic)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
12 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Brian Drolet, MD
Organizational Affiliation
Vanderbilt University Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Vanderbilt University Medical Center
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37235
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
IPD will not be shared with other researchers
Citations:
PubMed Identifier
33760691
Citation
Zakria D, Patrinely JR Jr, Dewan AK, Albers SE, Wheless LE, Simmons AN, Drolet BC. Intralesional corticosteroid injections are less painful without local anesthetic: a double-blind, randomized controlled trial. J Dermatolog Treat. 2022 Jun;33(4):2034-2037. doi: 10.1080/09546634.2021.1906842. Epub 2021 Apr 7.
Results Reference
derived

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Pain Outcomes Following Intralesional Corticosteroid Injections

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