Pain Outcomes Following Intralesional Corticosteroid Injections

NCT03630198 | Completed Phase 4 Results FDA Drug

• 1 other identifier: 181119
• Study Type: interventional
• Target: 31
• Locations: 1 country
• Sites: 1

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.

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

Keywords

corticosteroid; local anesthetic

Outcome Measures

Primary Outcomes (1)

• Pain Outcome: Visual Analog Scale

  Assessed using the visual analog scale (0-10 scale). Zero indicates no pain, 10 indicates worst pain ever.

  Assessed 1 minute after the injection (in clinic)

Study Arms (2)

Corticosteroid with lidocaine

ACTIVE COMPARATOR

This arm will include an injection mixture of corticosteroid and lidocaine

Drug: Corticosteroid with lidocaine

Corticosteroid with normal saline

EXPERIMENTAL

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.

Drug: Corticosteroid with normal saline

Interventions

Corticosteroid with lidocaine DRUG

Intralesional corticosteroid injection

Corticosteroid with lidocaine

Corticosteroid with normal saline DRUG

Intralesional corticosteroid injection

Corticosteroid with normal saline

Eligibility Criteria

• Age: 12 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• Unconsentable
• Not a candidate for corticosteroid injection
• Contraindication to lidocaine

Sponsors & Collaborators

• Vanderbilt University Medical Center: lead

Study Sites (1)

Vanderbilt University Medical Center

Nashville, Tennessee, 37235, United States

Location

Related Publications (1)

• 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.

  PMID: 33760691 DERIVED

MeSH Terms

Conditions

Keloid; Alopecia Areata; Acne Vulgaris; Cicatrix, Hypertrophic; Dermoid Cyst; Lichen Planus; Keratoacanthoma; Neurodermatitis; Granuloma Annulare; Scleroderma, Localized

Interventions

Adrenal Cortex Hormones; Lidocaine; Saline Solution

Condition Hierarchy (Ancestors)

Collagen Diseases; Connective Tissue Diseases; Skin and Connective Tissue Diseases; Cicatrix; Fibrosis; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Alopecia; Hypotrichosis; Hair Diseases; Skin Diseases; Acneiform Eruptions; Sebaceous Gland Diseases; Cysts; Neoplasms; Teratoma; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Lichenoid Eruptions; Skin Diseases, Papulosquamous; Dermatitis; Skin Diseases, Eczematous; Necrobiotic Disorders; Granuloma

Intervention Hierarchy (Ancestors)

Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Acetanilides; Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines; Crystalloid Solutions; Isotonic Solutions; Solutions; Pharmaceutical Preparations

Results Point of Contact

• Title: Dr. Brian Drolet
• Organization: Vanderbilt Univeristy Medical center

brian.c.drolet@vumc.org

615-322-2918

Study Officials

• Brian Drolet, MD

  Vanderbilt University Medical Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: August 9, 2018
• First Posted: August 14, 2018
• Study Start: October 1, 2018
• Primary Completion: September 1, 2019
• Study Completion: September 1, 2019
• Last Updated: March 11, 2021
• Results First Posted: March 11, 2021

Record last verified: 2021-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)