KeloidPhase 4NCT03630198
Pain Outcomes Following Intralesional Corticosteroid Injections
A Phase 4 study testing Corticosteroid with lidocaine and Corticosteroid with normal saline in people with Keloid and Alopecia Areata, run by Vanderbilt University Medical Center at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 12 years and olderHealthy volunteers can take part
- Conditions the study is for
- Keloid, Alopecia Areata, Acne
- What is being tested?
- Corticosteroid with lidocaine and Corticosteroid with normal saline
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 31 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Oct 2018to 1 Sep 2019
- Phase
- Phase 4
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 12 years and older
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- >12 years old presenting with an indication for intralesional steroid injection
Who cannot join
- Unconsentable
- Not a candidate for corticosteroid injection
- Contraindication to lidocaine
Trial locations and contacts
1 site in 1 country.
United States1 site
Vanderbilt University Medical Center
Nashville, Tennessee, 37235
About this study
Official title: The Use of Local Anesthetic in Intralesional Corticosteroid Injections; A Randomized, Double Blind Controlled Trial
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
- Being tested
- Corticosteroid with lidocaine, Corticosteroid with normal saline
- Keywords
- corticosteroid, local anesthetic
- Medical subject headings
- Keloid, Alopecia Areata, Acne Vulgaris, Cicatrix, Hypertrophic, Dermoid Cyst, Lichen Planus, Keratoacanthoma, Neurodermatitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Corticosteroid with lidocaineDrug
Intralesional corticosteroid injection
Corticosteroid with normal salineDrug
Intralesional corticosteroid injection
| Study group | Role | What they receive |
|---|---|---|
| Corticosteroid with lidocaine | Active comparator | This arm will include an injection mixture of corticosteroid and lidocaine Receives: 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. Receives: Drug: Corticosteroid with normal saline |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain Outcome: Visual Analog Scale
Assessed using the visual analog scale (0-10 scale). Zero indicates no pain, 10 indicates worst pain ever.
Measured: Assessed 1 minute after the injection (in clinic)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Aug 2018
- Study start1 Oct 2018
- Primary completion1 Sep 2019
- Study completion1 Sep 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for KeloidStudies of the same condition, open and under way.
- More trials run by Vanderbilt University Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 31 participants (actual)
Sponsor and investigators
- Lead sponsor
- Vanderbilt University Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Brian Drolet, Vanderbilt University Medical Center
- Investigators
- Brian Drolet, MD, Principal investigator, Vanderbilt University Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03630198
- Sponsor's protocol ID
- 181119
- Status last verified
- Feb 2021
- First submitted
- 9 Aug 2018
- Last updated
- 11 Mar 2021
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No: IPD will not be shared with other researchers
Publications
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.
PubMed 33760691
Study at a glance
From the registry record, last updated by the sponsor on 11 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Use of Local Anesthetic in Intralesional Corticosteroid Injections; A Randomized, Double Blind Controlled Trial
- ClinicalTrials.gov ID
- NCT03630198
- Acronym / sponsor ID
- 181119
- Conditions
- Keloid, Alopecia Areata, Acne, Hypertrophic Scar, Epidermal Inclusion Cyst, Frontal Fibrosing Alopecia
- Keywords
- corticosteroid, local anesthetic
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 31 participants (actual)
- Lead sponsor
- Vanderbilt University Medical CenterUniversity, hospital or other
- Study start
- 1 Oct 2018 (actual)
- Primary completion
- 1 Sep 2019 (actual)
- Study completion
- 1 Sep 2019 (actual)
- First posted
- 14 Aug 2018 (actual)
- Results
- Posted 11 Mar 2021
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Corticosteroid with lidocaine | Active comparator | Drug: Corticosteroid with lidocaineThis arm will include an injection mixture of corticosteroid and lidocaine |
| Corticosteroid with normal saline | Experimental | Drug: Corticosteroid with normal salineThis 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. |
Who may qualify
- Ages
- 12 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- >12 years old presenting with an indication for intralesional steroid injection
Key exclusion criteria (3 listed)
- Unconsentable
- Not a candidate for corticosteroid injection
- Contraindication to lidocaine
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Corticosteroid with lidocaineIntralesional corticosteroid injection | Drug | Corticosteroid with lidocaine |
| Corticosteroid with normal salineIntralesional corticosteroid injection | Drug | Corticosteroid with normal saline |
Primary outcome
Pain Outcome: Visual Analog Scale
Time frame: Assessed 1 minute after the injection (in clinic)
Assessed using the visual analog scale (0-10 scale). Zero indicates no pain, 10 indicates worst pain ever.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Mar 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 33760691Zakria 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.
- Individual participant dataSharing planned: No. IPD will not be shared with other researchers
Related trials for Keloid
Not yet recruiting
Fractional Radiofrequency With Streroids Versus Fractional CO2 Laser With Steroids in the Treatment of Keloids
Keloids
Active, not recruiting
Transdermal Versus Intralesional Betamethasone for Keloids
Keloid
RecruitingPhase 2
Ritlecitinib in Patients With Keloids or Those Undergoing Keloidectomy
Keloid
Recruiting
Radiotherapy for Keloids
Keloid
Not yet recruitingPhase 2
siRNA Microneedle Patches for Ear Keloid Post-Surgical Scars
Keloid of Ear Lobe
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Brian Drolet, MD principal investigator
Vanderbilt University Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Corticosteroid with lidocaine and Corticosteroid with normal saline in people with Keloid and Alopecia Areata, run by Vanderbilt University Medical Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 Mar 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 11 Mar 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pain Outcome: Visual Analog Scale (time frame: Assessed 1 minute after the injection (in clinic)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03630198, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Mar 2021.