KeloidNCT02996097
Fractional Laser Assisted Steroid Therapy vs Intralesional Steroids in the Treatment of Keloids
A study testing The Lutronic electronic carbon dioxide (eCO2) Plus laser system and Intralesional Triamcinolone Acetonide in people with Keloid, run by Johns Hopkins University at 1 site in United States.
Trial summary
The purpose of this study is to compare the effects of fractional carbon dioxide (CO2) laser therapy immediately followed by intralesional steroid therapy against intralesional steroid therapy alone for the treatment of keloids. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Keloid
- What is being tested?
- The Lutronic electronic carbon dioxide (eCO2) Plus laser system and Intralesional Triamcinolone Acetonide
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2016to 15 Jun 2018
- Phase
- Interventional
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male or female older than 17 at the screening visit;
- The subject is healthy, as determined by the investigator based on a medical evaluation including medical history;
- The subject has at least two keloids of comparative size and texture located on the same general anatomic location (trunk or back);
- The subject is willing and able to comply with the requirements of the protocol. In particular, subject must adhere to the visits schedule and concomitant therapy. The subject is willing to comply with the 4 week washout period;
- The subject has understood and signed an Informed Consent Form approved by the Institutional Review Board (IRB) prior to any investigational procedure
Who cannot join
- Any subject who is meeting one or more of the following exclusion criteria at the screening visit and/or at the baseline visit will not be included in this study:
- The subject has an underlying known disease, a surgical or medical condition that in the opinion of the investigator might put the subject at risk
- The subject is pregnant or breastfeeding at the time of enrollment or is planning to become pregnant at any point during the study period
- The subject has a past history of coagulopathy
- The subject has an underlying dermatological disease that in the opinion of the investigator could interfere with the study evaluations
- The subject has used prohibited topical or systemic treatments without sufficient protocol-defined wash-out period prior to Baseline (checked at Screening and Baseline) or is unwilling to refrain from use during the study
Show all 11Show fewer
- The subject is treated with anticoagulants or antiplatelet therapies
- The subject has a known allergy or sensitivity to any local anesthetic drug (e.g. EMLA or tetracaine 7%/lidocaine 23%) or a local antiseptic planned to be used for the laser.
- The subject is in an exclusion period from a previous study or is participating in another clinical trial
- The subject is an adult under guardianship or is hospitalized in a public or private institution, or is deprived of freedom
- The subject is unable to communicate or cooperate with the Investigator due to language problems, poor mental development, or impaired cerebral function
Trial locations and contacts
1 site in 1 country.
United States1 site
Johns Hopkins School of Medicine, Department of Dermatology
Baltimore, Maryland, 21287
About this study
The purpose of this study is to compare the effects of fractional carbon dioxide (CO2) laser therapy immediately followed by intralesional steroid therapy against intralesional steroid therapy alone for the treatment of keloids.
Read the detailed description
Intralesional corticosteroids remain the gold standard treatment for keloids. However, more effective therapies are desperately desired. Ablative fractional laser (AFL) treatment facilitates delivery of intralesional steroid more deeply and uniformly into the skin by creating vertical channels. Recent studies have showed that fractional laser assisted steroid therapy can be effective in the treatment of keloids. However the studies are lacking in comparing this treatment modality to the gold standard of intralesional steroids.
- Conditions
- Keloid
- Being tested
- The Lutronic electronic carbon dioxide (eCO2) Plus laser system, Intralesional Triamcinolone Acetonide
- Medical subject headings
- Keloid
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
The Lutronic electronic carbon dioxide (eCO2) Plus laser systemDevice
CO2 ablative laser plus intralesional triamcinolone acetonide A topical EMLA cream or tetracaine 7%/lidocaine 23% will be applied to the both treatment sites and after sufficient anesthesia is attained, one keloid will be treated with the fractional CO2 laser using standard protocol as practiced in our clinics followed by intralesional triamcinolone acetonide. One lesion would be treated with fractional CO2 ablative laser followed with intralesional triamcinolone acetonide at 4 weeks intervals
Intralesional Triamcinolone AcetonideDrug
| Study group | Role | What they receive |
|---|---|---|
| CO2 ablative laser plus intralesional triamcinolone acetonide | Experimental | A topical eutectic mixture of local anesthetics (EMLA) cream or tetracaine 7%/lidocaine 23% will be applied to the both treatment sites and after sufficient anesthesia is attained, one keloid will be treated with the fractional CO2 laser using standard protocol as practiced in our clinics followed by intralesional triamcinolone acetonide. One lesion would be treated with fractional CO2 ablative laser followed with intralesional triamcinolone acetonide at 4 weeks intervals Receives: Device: The Lutronic electronic carbon dioxide (eCO2) Plus laser system; Drug: Intralesional Triamcinolone Acetonide |
| Intralesional triamcinolone acetonide alone | Active comparator | A topical EMLA cream or tetracaine 7%/lidocaine 23% will be applied to the both treatment sites and after sufficient anesthesia is attained, one keloid will be treated with the fractional CO2 laser using standard protocol as practiced in our clinics followed by intralesional triamcinolone acetonide. The other chosen lesion would be treated with intralesional triamcinolone acetonide alone at 4 week intervals. Receives: Drug: Intralesional Triamcinolone Acetonide |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean Change in Composite Observer Score for Patient and Observer Scar Assessment Scale (POSAS)
Data from POSAS Observer Scale will be collected and reported to assess vascularity, pigmentation, thickness, relief, pliability, and surface area of the keloids chosen for the research study. Total score range: 6-60; Higher scores mean a worse outcome. Mean composite score of the final visit was compared to the mean baseline score.
Measured: Once every 4 weeks for 16 weeks
Mean Change in Composite Patient Score for Patient and Observer Scar Assessment Scale (POSAS)
Data from POSAS Observer Scale will be collected and reported to assess vascularity, pigmentation, thickness, relief, pliability, and surface area of the keloids chosen for the research study. Total score range: 6-60; Higher scores mean a worse outcome. Mean composite score of the final visit was compared to the mean baseline score.
Measured: Once every 4 weeks for 16 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Dec 2016 (estimated)
- Study startApr 2016
- Primary completion15 Jun 2018
- Study completion15 Jun 2018
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.
- Other trials for KeloidStudies of the same condition, open and under way.
- More trials run by Johns Hopkins UniversityThe 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Johns Hopkins University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Ginette Okoye, MD, Principal investigator, Johns Hopkins University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02996097
- Sponsor's protocol ID
- IRB00082453
- Status last verified
- Dec 2020
- First submitted
- 14 Dec 2016
- Last updated
- 17 Dec 2020
- Results posted
- Yes, on ClinicalTrials.gov
Study at a glance
From the registry record, last updated by the sponsor on 17 Dec 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Fractional Laser Assisted Steroid Therapy vs Intralesional Steroids in the Treatment of Keloids
- ClinicalTrials.gov ID
- NCT02996097
- Acronym / sponsor ID
- IRB00082453
- Conditions
- Keloid
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Johns Hopkins UniversityUniversity, hospital or other
- Study start
- Apr 2016 (actual)
- Primary completion
- 15 Jun 2018 (actual)
- Study completion
- 15 Jun 2018 (actual)
- First posted
- 19 Dec 2016 (estimated)
- Results
- Posted 25 Apr 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to compare the effects of fractional carbon dioxide (CO2) laser therapy immediately followed by intralesional steroid therapy against intralesional steroid therapy alone for the treatment of keloids.
Detailed description
Intralesional corticosteroids remain the gold standard treatment for keloids. However, more effective therapies are desperately desired. Ablative fractional laser (AFL) treatment facilitates delivery of intralesional steroid more deeply and uniformly into the skin by creating vertical channels. Recent studies have showed that fractional laser assisted steroid therapy can be effective in the treatment of keloids. However the studies are lacking in comparing this treatment modality to the gold standard of intralesional steroids.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| CO2 ablative laser plus intralesional triamcinolone acetonide | Experimental | Device: The Lutronic electronic carbon dioxide (eCO2) Plus laser system, Drug: Intralesional Triamcinolone AcetonideA topical eutectic mixture of local anesthetics (EMLA) cream or tetracaine 7%/lidocaine 23% will be applied to the both treatment sites and after sufficient anesthesia is attained, one keloid will be treated with the fractional CO2 laser using standard protocol as practiced in our clinics followed by intralesional triamcinolone acetonide. One lesion would be treated with fractional CO2 ablative laser followed with intralesional triamcinolone acetonide at 4 weeks intervals |
| Intralesional triamcinolone acetonide alone | Active comparator | Drug: Intralesional Triamcinolone AcetonideA topical EMLA cream or tetracaine 7%/lidocaine 23% will be applied to the both treatment sites and after sufficient anesthesia is attained, one keloid will be treated with the fractional CO2 laser using standard protocol as practiced in our clinics followed by intralesional triamcinolone acetonide. The other chosen lesion would be treated with intralesional triamcinolone acetonide alone at 4 week intervals. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Male or female older than 17 at the screening visit;
- The subject is healthy, as determined by the investigator based on a medical evaluation including medical history;
- The subject has at least two keloids of comparative size and texture located on the same general anatomic location (trunk or back);
- The subject is willing and able to comply with the requirements of the protocol. In particular, subject must adhere to the visits schedule and concomitant therapy. The subject is willing to comply with the 4 week washout period;
- The subject has understood and signed an Informed Consent Form approved by the Institutional Review Board (IRB) prior to any investigational procedure
Key exclusion criteria (11 listed)
- Any subject who is meeting one or more of the following exclusion criteria at the screening visit and/or at the baseline visit will not be included in this study:
- The subject has an underlying known disease, a surgical or medical condition that in the opinion of the investigator might put the subject at risk
- The subject is pregnant or breastfeeding at the time of enrollment or is planning to become pregnant at any point during the study period
- The subject has a past history of coagulopathy
- The subject has an underlying dermatological disease that in the opinion of the investigator could interfere with the study evaluations
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 |
|---|---|---|
| The Lutronic electronic carbon dioxide (eCO2) Plus laser systemCO2 ablative laser plus intralesional triamcinolone acetonide A topical EMLA cream or tetracaine 7%/lidocaine 23% will be applied to the both treatment sites and after sufficient anesthesia is attained, one keloid will be treated with the fractional CO2 laser using standard protocol as practiced in our clinics followed by intralesional triamcinolone acetonide. One lesion would be treated with fractional CO2 ablative laser followed with intralesional triamcinolone acetonide at 4 weeks intervals | Device | CO2 ablative laser plus intralesional triamcinolone acetonide |
| Intralesional Triamcinolone Acetonide | Drug | CO2 ablative laser plus intralesional triamcinolone acetonide, Intralesional triamcinolone acetonide alone |
Primary outcome
Mean Change in Composite Observer Score for Patient and Observer Scar Assessment Scale (POSAS)
Time frame: Once every 4 weeks for 16 weeks
Data from POSAS Observer Scale will be collected and reported to assess vascularity, pigmentation, thickness, relief, pliability, and surface area of the keloids chosen for the research study. Total score range: 6-60; Higher scores mean a worse outcome. Mean composite score of the final visit was compared to the mean baseline score.
Mean Change in Composite Patient Score for Patient and Observer Scar Assessment Scale (POSAS)
Time frame: Once every 4 weeks for 16 weeks
Data from POSAS Observer Scale will be collected and reported to assess vascularity, pigmentation, thickness, relief, pliability, and surface area of the keloids chosen for the research study. Total score range: 6-60; Higher scores mean a worse outcome. Mean composite score of the final visit was compared to the mean baseline score.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Dec 2020.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
Ginette Okoye, MD principal investigator
Johns Hopkins University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing The Lutronic electronic carbon dioxide (eCO2) Plus laser system and Intralesional Triamcinolone Acetonide in people with Keloid, run by Johns Hopkins University 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 5 inclusion and 11 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 17 Dec 2020. 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.
Are results available for this study?
Yes. Results are posted in the registry (first posted 25 Apr 2019). 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?
Mean Change in Composite Observer Score for Patient and Observer Scar Assessment Scale (POSAS) (time frame: Once every 4 weeks for 16 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 17 Dec 2020; AzTrials last refreshed its copy on 8 Nov 2026.