A Phase 4 interventional study of Corticosteroid with lidocaine and Corticosteroid with normal saline in Keloid, Alopecia Areata and Acne, sponsored by Vanderbilt University Medical Center. Completed at 1 site in United States. Open to participants aged 12 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2021-03-11.
Sponsored by Vanderbilt University Medical Center · Phase 4, Interventional, and Treatment
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.
138 studies on the registry are indexed under Keloid; 26 are open to participants now.
This study's enrollment of 31 is close to the median of 30 across 109 interventional studies indexed under Keloid.
Browse Keloid studies →Vanderbilt University Medical Center is the lead sponsor of 833 studies on the registry; 155 are open to participants now.
Of its 125 completed or terminated interventional studies of FDA-regulated products, 92 (74%) have results posted.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
This arm will include an injection mixture of corticosteroid and lidocaine
Drug: Corticosteroid with 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.
Drug: Corticosteroid with normal saline
Drug page: Lidocaine
Intralesional corticosteroid injection
Intralesional corticosteroid injection
Pain Outcome: Visual Analog Scale
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)
| Milestone | Corticosteroid With Lidocaine | Corticosteroid With Normal Saline |
|---|---|---|
| Started | 13 | 18 |
| Completed | 13 | 18 |
| Not completed | 0 | 0 |
Assessed using the visual analog scale (0-10 scale). Zero indicates no pain, 10 indicates worst pain ever.
| Score on a scale | Corticosteroid With Lidocaine | Corticosteroid With Normal Saline |
|---|---|---|
| Pain Outcome: Visual Analog Scale | 5.4 ± 2.4 | 2.7 ± 2.3 |
Assessed using the visual analog scale (0-10 scale). Zero indicates no pain, 10 indicates worst pain ever.
| Score on a scale | Corticosteroid With Lidocaine | Corticosteroid With Normal Saline |
|---|---|---|
| Pain (6 hour) | 0.9 ± 2.1 | 0.1 ± 1.5 |
| Pain (24 hour) | 0 ± 0 | 0 ± 0 |
Collected over 1 year after injection. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Corticosteroid With Lidocaine | 0/13 (0%) | 0/13 (0%) | 0/13 (0%) |
| Corticosteroid With Normal Saline | 0/18 (0%) | 0/18 (0%) | 0/18 (0%) |
| Age, Categorical(Participants) | Corticosteroid With Lidocaine | Corticosteroid With Normal Saline | Total |
|---|---|---|---|
| <=18 years | 0 | 0 | 0 |
| Between 18 and 65 years | 13 | 18 | 31 |
| >=65 years | 0 | 0 | 0 |
| Age, Continuous(years) | Corticosteroid With Lidocaine | Corticosteroid With Normal Saline | Total |
|---|---|---|---|
| Mean | 33 ± 18.2 | 52 ± 19.2 | 43 ± 20.3 |
| Sex: Female, Male(Participants) | Corticosteroid With Lidocaine | Corticosteroid With Normal Saline | Total |
|---|---|---|---|
| Female | 6 | 10 | 16 |
| Male | 7 | 8 | 15 |
| Race and Ethnicity Not Collected(Participants) | Corticosteroid With Lidocaine | Corticosteroid With Normal Saline | Total |
|---|---|---|---|
| Count of participants | — | — | 0 |
| Region of Enrollment(Participants) | Corticosteroid With Lidocaine | Corticosteroid With Normal Saline | Total |
|---|---|---|---|
| United States | 13 | 18 | 31 |
PDFs hosted by the registry, ClinicalTrials.gov.
Plan to share: No — IPD will not be shared with other researchers
Ran from Oct 2018 to primary completion in Sep 2019, 11 months.
Results were first posted in Mar 2021, 1 year 6 months after primary completion.
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This study is completed, as verified in Feb 2021. You cannot join it, but the record below documents what was studied.
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